85. 特発性間質性肺炎 Idiopathic interstitial pneumonia Clinical trials / Disease details
臨床試験数 : 627 / 薬物数 : 443 - (DrugBank : 120) / 標的遺伝子数 : 99 - 標的パスウェイ数 : 212
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | NCT05571059 (ClinicalTrials.gov) | June 2023 | 27/9/2022 | Oral Ifetroban in Patients With Idiopathic Pulmonary Fibrosis (IPF) | A Randomized, Double-Blind, Placebo-Controlled Phase II Study With an Open-Label Extension to Determine the Safety and Efficacy of Oral Ifetroban in Patients With Idiopathic Pulmonary Fibrosis (IPF) | Idiopathic Pulmonary Fibrosis | Drug: Ifetroban Sodium;Drug: Placebo | Cumberland Pharmaceuticals | NULL | Not yet recruiting | 40 Years | 80 Years | All | 128 | Phase 2 | NULL |
| 2 | NCT05674994 (ClinicalTrials.gov) | March 15, 2023 | 9/12/2022 | Glucocorticoids Versus Placebo for the Treatment of Acute Exacerbation of Idiopathic Pulmonary Fibrosis | Glucocorticoids Versus Placebo for the Treatment of Acute Exacerbation of Idiopathic Pulmonary Fibrosis: a Randomized Controlled Trial | Acute Exacerbation of Idiopathic Pulmonary Fibrosis | Drug: Methylprednisone/Prednisone;Other: Placebo | Groupe Hospitalier Paris Saint Joseph | NULL | Not yet recruiting | 18 Years | N/A | All | 110 | Phase 3 | France |
| 3 | NCT05195918 (ClinicalTrials.gov) | March 1, 2023 | 2/12/2021 | Study of Oral Epigallocatechin-3-gallate (EGCG) in IPF Patients | Dose Ranging Study of Oral Epigallocatechin-3-gallate (EGCG) Given Daily for 12 Weeks to Patients With Idiopathic Pulmonary Fibrosis (IPF) Evaluating Safety, PK Interactions With Standard of Care Drugs, and Biomarkers of Drug Effect | Idiopathic Pulmonary Fibrosis | Combination Product: EGCG 300 mg + Nintedanib;Combination Product: EGCG 300 mg + Pirfenidone;Combination Product: Placebo 2 capsules + Nintedanib or Pirfenidone;Combination Product: EGCG 600 mg + Nintedanib;Combination Product: EGCG 600 mg + Pirfenidone;Combination Product: Placebo 4 capsules + Nintedanib or Pirfenidone | Hal Chapman | University of Michigan;Cornell University;Massachusetts General Hospital;Temple University;University of Washington | Not yet recruiting | 40 Years | 85 Years | All | 50 | Phase 1 | United States |
| 4 | NCT05349760 (ClinicalTrials.gov) | March 2023 | 31/3/2022 | A Phase 2 Study to Evaluate Safety and Efficacy of AMB-05X in Subjects With Idiopathic Pulmonary Fibrosis | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of AMB-05X in Subjects With Idiopathic Pulmonary Fibrosis | IPF | Biological: AMB-05X;Drug: Placebo | AmMax Bio, Inc. | NULL | Withdrawn | 40 Years | N/A | All | 0 | Phase 2 | NULL |
| 5 | NCT05671835 (ClinicalTrials.gov) | March 2023 | 3/1/2023 | Study of TTI-101 in Participants With Idiopathic Pulmonary Fibrosis | REVERT-IPF: A Phase 2 Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of TTI-101 in Participants With Idiopathic Pulmonary Fibrosis | Idiopathic Pulmonary Fibrosis | Drug: TTI-101;Drug: Placebo | Tvardi Therapeutics, Incorporated | NULL | Recruiting | 40 Years | N/A | All | 100 | Phase 2 | United States |
| 6 | NCT05483907 (ClinicalTrials.gov) | February 21, 2023 | 27/7/2022 | To Evaluate the Efficacy, Safety, and Tolerability of BBT-877 in Patients With IPF | A Phase 2, Randomized, Double-blind, Placebo-controlled, 24-Week Study to Evaluate the Efficacy, Safety, and Tolerability of BBT-877, as Mono- or add-on Therapy, in Patients With Idiopathic Pulmonary Fibrosis (IPF) | Idiopathic Pulmonary Fibrosis | Drug: BBT-877;Drug: Placebo | Bridge Biotherapeutics, Inc. | NULL | Recruiting | 40 Years | N/A | All | 120 | Phase 2 | United States;Australia;Israel |
| 7 | NCT05722964 (ClinicalTrials.gov) | February 2023 | 11/1/2023 | Study on Intravenous Injection of SHR-1906 in the Treatment of Idiopathic Pulmonary Fibrosis | Efficacy and Safety of Intravenous Infusion of SHR-1906 in Patients With Idiopathic Pulmonary Fibrosis: a Multicenter, Randomized, Double-blind, Parallel Placebo-controlled Phase II Trial | Idiopathic Pulmonary Fibrosis | Drug: SHR-1906;Drug: Placebo | Guangdong Hengrui Pharmaceutical Co., Ltd | NULL | Not yet recruiting | 40 Years | 80 Years | All | 108 | Phase 2 | NULL |
| 8 | EUCTR2022-001091-34-DK (EUCTR) | 26/01/2023 | 13/12/2022 | A study to find out whether BI 1015550 improves lung functionin people with Idiopathic Pulmonary Fibrosis (IPF) | A double blind, randomized, placebo-controlled trial evaluatingthe efficacy and safety of BI 1015550 over at least 52 weeks inpatients with Idiopathic Pulmonary Fibrosis (IPF) - PDE4 Phase III trial in IPF (Fibroneer- IPF) | Idiopathic Pulmonary Fibrosis (IPF) MedDRA version: 21.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: BI 1015550 9 mg Film Coated Tablet Product Code: BI 1015550 Other descriptive name: BI 1015550 Product Name: BI 1015550 18 mg Film Coated Tablet Product Code: BI 1015550 Other descriptive name: BI 1015550 | Boehringer Ingelheim France | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 963 | Phase 3 | Serbia;Portugal;United States;Saudi Arabia;Taiwan;Estonia;Greece;Spain;Thailand;Ukraine;Ireland;Russian Federation;Israel;Chile;Italy;Switzerland;India;France;Malaysia;Australia;Denmark;South Africa;Netherlands;China;Korea, Republic of;Czechia;Slovenia;Finland;Turkey;Austria;United Kingdom;Egypt;Hungary;Mexico;Canada;Argentina;Belgium;Poland;Brazil;Singapore;Croatia;Georgia;Norway;Germany;Japan;New Zealand;Sweden | ||
| 9 | NCT05513950 (ClinicalTrials.gov) | January 25, 2023 | 17/8/2022 | A Study to Investigate the Safety, Tolerability, and Pharmacokinetics of Monoclonal Antibody (mAb) in Patients With IPF | A Phase Ib, Randomised, Double-blind, Placebo-controlled Study to Investigate the Safety, Tolerability, and Pharmacokinetics of an Intravenous Monoclonal Antibody (mAB) After Single Ascending Doses in Subjects Affected by Idiopathic Pulmonary Fibrosis | Idiopathic Pulmonary Fibrosis | Biological: CHF10067 starting dose;Biological: CHF10067 intermediate dose;Biological: CHF10067 high dose;Drug: Placebo | Chiesi Farmaceutici S.p.A. | NULL | Recruiting | 40 Years | 80 Years | All | 24 | Phase 1 | United Kingdom |
| 10 | NCT03800017 (ClinicalTrials.gov) | January 1, 2023 | 21/11/2018 | Skeletal Muscle Function in Interstitial Lung Disease | Investigating the Role of Skeletal Muscle Dysfunction on Dyspnea and Exercise Intolerance in Interstitial Lung Disease | Interstitial Lung Disease;Idiopathic Pulmonary Fibrosis;Hypersensitivity Pneumonitis;Scleroderma;Nonspecific Interstitial Pneumonia | Biological: Hyperoxia | University of British Columbia | NULL | Not yet recruiting | 40 Years | 80 Years | All | 40 | N/A | NULL |
| 11 | EUCTR2021-006820-41-GR (EUCTR) | 23/12/2022 | 16/09/2022 | A Randomized Double-blind Trial to Evaluate the Efficacy, Tolerability, Safety and Dose Response of LYT-100 in Patients with Idiopathic Pulmonary Fibrosis | A Randomized Double-blind, Four-Arm Active and Placebo-controlled Dose-Finding Trial to Evaluate the Efficacy, Tolerability, Safety and Dose Response of LYT-100 in Patients with Idiopathic Pulmonary Fibrosis (IPF). | Idiopathic Pulmonary Fibrosis (IPF);Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: deupirfenidone Product Code: LYT-100 INN or Proposed INN: deupirfenidone Other descriptive name: Pirfenidone, deuterated Product Name: pirfenidone INN or Proposed INN: Pirfenidone Other descriptive name: Pirfenidone | PureTech LYT 100, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 240 | Phase 2 | Serbia;United States;Czechia;Taiwan;Greece;Thailand;Chile;Colombia;India;Mexico;Argentina;Malaysia;Poland;Romania;Georgia;Korea, Republic of | ||
| 12 | EUCTR2022-001091-34-GR (EUCTR) | 21/12/2022 | 02/11/2022 | A study to find out whether BI 1015550 improves lung functionin people with Idiopathic Pulmonary Fibrosis (IPF) | A double blind, randomized, placebo-controlled trial evaluatingthe efficacy and safety of BI 1015550 over at least 52 weeks inpatients with Idiopathic Pulmonary Fibrosis (IPF) - PDE4 Phase III trial in IPF (Fibroneer- IPF) | Idiopathic Pulmonary Fibrosis (IPF) MedDRA version: 21.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: BI 1015550 9 mg Film Coated Tablet Product Code: BI 1015550 INN or Proposed INN: BI 1015550 Other descriptive name: BI 1015550 Product Name: BI 1015550 18 mg Film Coated Tablet Product Code: BI 1015550 INN or Proposed INN: BI 1015550 Other descriptive name: BI 1015550 | Boehringer Ingelheim B.V | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 963 | Phase 3 | Serbia;Portugal;United States;Saudi Arabia;Taiwan;Estonia;Greece;Spain;Thailand;Ukraine;Ireland;Russian Federation;Israel;Chile;Italy;Switzerland;India;France;Malaysia;Denmark;Australia;South Africa;Netherlands;China;Korea, Republic of;Czechia;Slovenia;Finland;Turkey;Austria;United Kingdom;Egypt;Hungary;Mexico;Canada;Argentina;Belgium;Poland;Brazil;Singapore;Croatia;Georgia;Norway;Germany;Japan;New Zealand;Sweden | ||
| 13 | EUCTR2022-001091-34-IE (EUCTR) | 19/12/2022 | 28/07/2022 | A study to find out whether BI 1015550 improves lung functionin people with Idiopathic Pulmonary Fibrosis (IPF) | A double blind, randomized, placebo-controlled trial evaluatingthe efficacy and safety of BI 1015550 over at least 52 weeks inpatients with Idiopathic Pulmonary Fibrosis (IPF) - FIBRONEER-IPF | Idiopathic Pulmonary Fibrosis (IPF) MedDRA version: 21.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: BI 1015550 9 mg Film Coated Tablet Product Code: BI 1015550 Other descriptive name: BI 1015550 Product Name: BI 1015550 18 mg Film Coated Tablet Product Code: BI 1015550 Other descriptive name: BI 1015550 | Boehringer Ingelheim International GmbH | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 963 | Phase 3 | Germany;Japan;New Zealand;Sweden;Serbia;Portugal;United States;Saudi Arabia;Taiwan;Estonia;Greece;Spain;Thailand;Ireland;Israel;Chile;Italy;Switzerland;India;France;Malaysia;Denmark;Australia;South Africa;Netherlands;China;Korea, Republic of;Czechia;Slovenia;Finland;Turkey;Austria;United Kingdom;Egypt;Hungary;Mexico;Canada;Argentina;Belgium;Poland;Brazil;Singapore;Croatia;Georgia;Norway | ||
| 14 | EUCTR2022-001091-34-NL (EUCTR) | 05/12/2022 | 13/10/2022 | A study to find out whether BI 1015550 improves lung functionin people with Idiopathic Pulmonary Fibrosis (IPF) | A double blind, randomized, placebo-controlled trial evaluatingthe efficacy and safety of BI 1015550 over at least 52 weeks inpatients with Idiopathic Pulmonary Fibrosis (IPF) - PDE4 Phase III trial in IPF (Fibroneer- IPF) | Idiopathic Pulmonary Fibrosis (IPF) MedDRA version: 21.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: BI 1015550 9 mg Film Coated Tablet Product Code: BI 1015550 INN or Proposed INN: Not assigned yet Other descriptive name: BI 1015550 Product Name: BI 1015550 18 mg Film Coated Tablet Product Code: BI 1015550 INN or Proposed INN: Not assigned yet Other descriptive name: BI 1015550 | Boehringer Ingelheim BV Netherlands | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 963 | Phase 3 | Serbia;Portugal;United States;Saudi Arabia;Taiwan;Estonia;Greece;Spain;Thailand;Ukraine;Ireland;Russian Federation;Israel;Chile;Italy;Switzerland;India;France;Malaysia;Denmark;Australia;South Africa;Netherlands;China;Korea, Republic of;Czechia;Slovenia;Finland;Turkey;Austria;United Kingdom;Egypt;Hungary;Mexico;Canada;Argentina;Belgium;Poland;Brazil;Singapore;Croatia;Georgia;Norway;Germany;Japan;New Zealand;Sweden | ||
| 15 | NCT05497284 (ClinicalTrials.gov) | November 10, 2022 | 5/8/2022 | To Assess the Efficacy of the Investigational Products Compared to Placebo in Participants With IPF | A Participant- and Investigator-blinded, Randomized, Placebo-controlled, Multicenter, Platform Study to Investigate Efficacy, Safety, and Tolerability of Various Single Treatments in Participants With Idiopathic Pulmonary Fibrosis | Idiopathic Pulmonary Fibrosis | Drug: LTP001;Drug: Placebo;Drug: Standard of Care (SoC) | Novartis Pharmaceuticals | NULL | Recruiting | 40 Years | N/A | All | 94 | Phase 2 | United States;Argentina;Australia |
| 16 | NCT05255991 (ClinicalTrials.gov) | October 4, 2022 | 15/2/2022 | Multinational Study of Efficacy and Safety of Inhaled Treprostinil in Subjects With Idiopathic Pulmonary Fibrosis | A Randomized, Double-blind, Placebo-controlled, Multinational, Phase 3 Study of the Efficacy and Safety of Inhaled Treprostinil in Subjects With Idiopathic Pulmonary Fibrosis (TETON-2) | Idiopathic Pulmonary Fibrosis;Interstitial Lung Disease | Drug: Placebo;Drug: Inhaled Treprostinil;Device: Treprostinil Ultrasonic Nebulizer | United Therapeutics | NULL | Recruiting | 40 Years | N/A | All | 396 | Phase 3 | Argentina;Australia;Chile;Denmark;France;Israel;Korea, Republic of;Mexico;Spain;Taiwan |
| 17 | NCT05468502 (ClinicalTrials.gov) | October 2022 | 12/7/2022 | Phase I/IIa Clinical Trial of Human Umbilical Cord Mesenchymal Stem Cell Injection in the Treatment of Idiopathic Pulmonary Fibrosis (IPF) | An Open Clinical Study to Explore the Safety, Tolerance and Preliminary Efficacy of Human Umbilical Cord Mesenchymal Stem Cell Injection in the Treatment of Idiopathic Pulmonary Fibrosis (IPF) | Idiopathic Pulmonary Fibrosis | Drug: Human umbilical cord mesenchymal stem cell injection | Shanghai Life Science & Technology | NULL | Recruiting | 50 Years | 75 Years | All | 18 | Phase 1 | China |
| 18 | NCT05321069 (ClinicalTrials.gov) | September 19, 2022 | 4/4/2022 | A Study to Find Out Whether BI 1015550 Improves Lung Function in People With Idiopathic Pulmonary Fibrosis (IPF) | A Double Blind, Randomized, Placebo-controlled Trial Evaluating the Efficacy and Safety of BI 1015550 Over at Least 52 Weeks in Patients With Idiopathic Pulmonary Fibrosis (IPF) | Idiopathic Pulmonary Fibrosis | Drug: BI 1015550;Drug: Placebo | Boehringer Ingelheim | NULL | Recruiting | 40 Years | N/A | All | 963 | Phase 3 | United States;Australia;Austria;Belgium;Brazil;Canada;China;Denmark;Estonia;Finland;France;Germany;Greece;Italy;Japan;Korea, Republic of;Malaysia;Mexico;Netherlands;New Zealand;Norway;Poland;Puerto Rico;Singapore;Spain;Sweden;Taiwan;Thailand;United Kingdom |
| 19 | EUCTR2021-005881-17-DK (EUCTR) | 12/09/2022 | 15/07/2022 | A study evaluating the efficacy and safety of inhaled treprostinil in subjects with idiopathic pulmonary fibrosis | A Randomized, Double-blind, Placebo-controlled, Multinational, Phase 3 Study of the Efficacy and Safety of Inhaled Treprostinil in Subjects with Idiopathic Pulmonary Fibrosis (TETON-2) | Idiopathic Pulmonary Fibrosis MedDRA version: 21.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Trade Name: TYVASO® (treprostinil) inhalation solution, for oral inhalation use Product Name: Treprostinil INN or Proposed INN: Treprostinil | UNITED THERAPEUTICS CORPORATION | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 396 | Phase 3 | Taiwan;Spain;Chile;Israel;United Kingdom;Italy;France;Mexico;Argentina;Belgium;Denmark;Australia;Peru;Germany;Netherlands;New Zealand;Korea, Republic of | ||
| 20 | NCT05570058 (ClinicalTrials.gov) | September 8, 2022 | 28/9/2022 | Study to Assess the Safety, Pharmacokinetics, Pharmacodynamics and Clinical Activity of RXC007 in Idiopathic Pulmonary Fibrosis | A Multi-Cohort, Randomised, Placebo-Controlled Phase 2a Study to Assess the Safety, Pharmacokinetics, Pharmacodynamics and Clinical Activity of Ascending Doses of RXC007 in Patients With Idiopathic Pulmonary Fibrosis | IPF;Fibrosis | Drug: RXC007;Drug: Placebo | Redx Pharma Plc | Simbec Research | Recruiting | 40 Years | 80 Years | All | 64 | Phase 2 | Belgium;Czechia;Italy;Spain;United Kingdom |
| 21 | EUCTR2021-006278-22-NL (EUCTR) | 29/08/2022 | 01/06/2022 | A study to find out if orvepitant is safe to use and reduces the severity of cough in patients with idiopathic pulmonary fibrosis | A DOUBLE-BLIND, RANDOMISED, PLACEBO CONTROLLED, TWO PERIOD CROSS-OVER STUDY TO EVALUATE THE EFFICACY AND SAFETY OF ORVEPITANT IN CHRONIC COUGH IN PATIENTS WITH IDIOPATHIC PULMONARY FIBROSIS | Chronic cough in patients with idiopathic pulmonary fibrosis MedDRA version: 21.1;Level: LLT;Classification code 10066656;Term: Chronic cough;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: Orvepitant INN or Proposed INN: ORVEPITANT Product Name: Orvepitant INN or Proposed INN: ORVEPITANT | NeRRe Therapeutics Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 108 | Phase 2 | United States;Netherlands;United Kingdom | ||
| 22 | NCT05428150 (ClinicalTrials.gov) | August 8, 2022 | 15/6/2022 | Randomized, Crossover, Multi-Dose Pharmacokinetics of EXCL-100 Pirfenidone-Sustained Release Tablet and Esbriet in Healthy Volunteers | Randomized, Crossover, Multi-Dose, Steady State, Comparative Pharmacokinetics and Relative Bioavailability Study of EXCL-100 Pirfenidone-Sustained Release Tablet (EXCL-100), and Esbriet® in Healthy Volunteers | Idiopathic Pulmonary Fibrosis | Drug: Esbriet 267 MG Oral Capsule;Drug: EXCL-100, 600 MG Oral Tablet | Excalibur Pharmaceuticals, Inc. | NULL | Completed | 18 Years | 65 Years | All | 32 | Phase 1 | United States |
| 23 | NCT05185089 (ClinicalTrials.gov) | August 1, 2022 | 23/12/2021 | Efficacy and Safety Study of Orvepitant for Chronic Cough in Patients With Idiopathic Pulmonary Fibrosis | A Double-Blind, Randomised, Placebo Controlled, Two Period Cross-Over Study to Evaluate the Efficacy and Safety of Orvepitant in Chronic Cough in Patients With Idiopathic Pulmonary Fibrosis | Cough;Idiopathic Pulmonary Fibrosis | Drug: Orvepitant Maleate;Drug: Placebo | Nerre Therapeutics Ltd. | Pharm-Olam International | Recruiting | 40 Years | N/A | All | 88 | Phase 2 | United States;Netherlands;United Kingdom |
| 24 | NCT05389215 (ClinicalTrials.gov) | July 29, 2022 | 17/4/2022 | Clinical Trial to Evaluate the Safety and Efficacy of DWN12088 in Patients With IPF | A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of DWN12088 in Patients With Idiopathic Pulmonary Fibrosis | Idiopathic Pulmonary Fibrosis | Drug: DWN12088;Drug: Placebo | Daewoong Pharmaceutical Co. LTD. | NULL | Recruiting | 40 Years | N/A | All | 102 | Phase 2 | United States;Korea, Republic of |
| 25 | NCT05321420 (ClinicalTrials.gov) | July 29, 2022 | 2/4/2022 | LYT-100 in Patients With Idiopathic Pulmonary Fibrosis (IPF) | A Randomized Double-blind, Four-Arm Active and Placebo-controlled Dose-Finding Trial to Evaluate the Efficacy, Tolerability, Safety and Dose Response of LYT-100 in Patients With Idiopathic Pulmonary Fibrosis (IPF) | Idiopathic Pulmonary Fibrosis | Drug: Placebo;Drug: Pirfenidone;Drug: Deupirfenidone | PureTech | NULL | Recruiting | 40 Years | N/A | All | 240 | Phase 2 | United States;Argentina;Georgia;Greece;India;Malaysia;Romania;Thailand |
| 26 | NCT05241275 (ClinicalTrials.gov) | July 19, 2022 | 3/2/2022 | Xenon MRI and Progressive ILD | XENON ILD: 129Xe MRI to Evaluate aNtifibrotic respOnse and progressioN in ILD | Idiopathic Pulmonary Fibrosis;Progressive Pulmonary Fibrosis | Drug: Hyperpolarized 129 Xenon Gas Comparing Progressive Pulmonary Fibrosis Treatment | Duke University | Boehringer Ingelheim | Recruiting | 18 Years | N/A | All | 75 | Phase 2 | United States |
| 27 | NCT05621252 (ClinicalTrials.gov) | July 13, 2022 | 2/11/2022 | Imaging Evaluation of PLN-74809 in Participants With IPF (PLN-74809) | A Phase 2a, Randomized, Double-Blind, Placebo-Controlled, Evaluation of PLN-74809 on Type 1 Collagen Deposition Using 68Ga-CBP8 PET/MRI Imaging in Participants With Idiopathic Pulmonary Fibrosis (IPF) | Idiopathic Pulmonary Fibrosis | Drug: PLN-74809;Drug: Placebo | Pliant Therapeutics, Inc. | NULL | Recruiting | 40 Years | N/A | All | 12 | Phase 2 | United States |
| 28 | NCT05016817 (ClinicalTrials.gov) | July 3, 2022 | 17/8/2021 | Safety of Cultured Allogeneic Adult Umbilical Cord Derived Mesenchymal Stem Cell Intravenous Infusion for IPF | Safety of Cultured Allogeneic Adult Umbilical Cord Derived Mesenchymal Stem Cell Intravenous Infusion for the Treatment of Idiopathic Pulmonary Fibrosis | Idiopathic Pulmonary Fibrosis | Biological: AlloRx | The Foundation for Orthopaedics and Regenerative Medicine | NULL | Recruiting | N/A | N/A | All | 20 | Phase 1 | Antigua and Barbuda;Argentina;Mexico |
| 29 | ChiCTR2200058688 | 2022-07-01 | 2022-04-14 | A prospective, single-center, randomized controlled trial of glucocorticoid impulse therapy for acute exacerbation of idiopathic pulmonary fibrosis | A prospective, single-center, randomized controlled trial of glucocorticoid impulse therapy for acute exacerbation of idiopathic pulmonary fibrosis | Acute exacerbation of idiopathic pulmonary fibrosis | Glucocorticoid impulse therapy group:Methylprednisolone 500mg/qd intravenous for 3 days;High dose glucocorticoid control group:Methylprednisolone 160mg/qd intravenous for 3 days,then taped gradually.; | Nanjing Drum Tower Hospital, The Affiliated Nanjing University Medical School | NULL | Pending | Both | Glucocorticoid impulse therapy group:30;High dose glucocorticoid control group:30; | N/A | China | ||
| 30 | NCT05427253 (ClinicalTrials.gov) | June 15, 2022 | 7/6/2022 | First-in-human Trial to Evaluate the Safety, Tolerability and Pharmacokinetics of C106 in Healthy Subjects | A Double-blind, Placebo-controlled, Randomised, First in Human Trial to Evaluate the Safety, Tolerability and Pharmacokinetics of Single and Multiple Ascending Oral Doses of C106 in Healthy Male and Female Subjects | Safety Issues;Tolerance;Idiopathic Pulmonary Fibrosis;Pulmonary Hypertension | Drug: C106 solution;Drug: Placebo | Vicore Pharma AB | NULL | Recruiting | 18 Years | 65 Years | All | 72 | Phase 1 | Sweden |
| 31 | NCT05387785 (ClinicalTrials.gov) | June 2022 | 17/5/2022 | Study to Assess the Safety and Tolerability of ANG-3070 in Subjects With Idiopathic Pulmonary Fibrosis | A Multicenter, Randomized, Double-Blind, Placebo-Controlled, 2-Period, 2-Arm, 4-Sequence, Crossover Phase 1b Study to Assess the Safety, Tolerability, and Pharmacokinetics of Ang-3070 in Subjects With Idiopathic Pulmonary Fibrosis Who Are Treatment-Naïve or Who Have Failed or Refused Standard of Care Treatment | Idiopathic Pulmonary Fibrosis (IPF) | Drug: ANG-3070;Drug: Placebo | Angion Biomedica Corp | NULL | Not yet recruiting | 40 Years | N/A | All | 20 | Phase 1 | NULL |
| 32 | NCT05373914 (ClinicalTrials.gov) | May 31, 2022 | 10/5/2022 | RESPIRARE - Efficacy and Safety of Cudetaxestat in Patients With Idiopathic Pulmonary Fibrosis (IPF) | RESPIRARE - A Phase 2, Randomized, Double-blinded, Placebo-controlled, Efficacy and Safety Study of Cudetaxestat (BLD-0409) Assessed Across Three Dose Ranges With or Without Standard of Care (Nintedanib or Pirfenidone) in Patients With Idiopathic Pulmonary Fibrosis (IPF) | Idiopathic Pulmonary Fibrosis | Drug: Cudetaxestat (BLD-0409);Drug: Control: Matching Placebo | Blade Therapeutics | NULL | Not yet recruiting | 40 Years | 85 Years | All | 200 | Phase 2 | NULL |
| 33 | EUCTR2021-003162-12-DK (EUCTR) | 21/04/2022 | 10/12/2021 | CSL312 Safety, Pharmacokinetics, and Pharmacodynamics in Idiopathic Pulmonary Fibrosis | A Randomized, Double-blind, Placebo-controlled, Study to Investigate the Safety, Pharmacokinetics, and Pharmacodynamics of CSL312 in Subjects with Idiopathic Pulmonary Fibrosis | Idiopathic Pulmonary Fibrosis MedDRA version: 21.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders MedDRA version: 20.0;Level: SOC;Classification code 10038738;Term: Respiratory, thoracic and mediastinal disorders;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: Factor XIIa antagonist monoclonal antibody Product Code: CSL312 Garadacimab INN or Proposed INN: FXIIa inhibitor monoclonal antibody Other descriptive name: Garadacimab | CSL Behring LLC | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 80 | Phase 2 | United States;Czechia;Spain;Ukraine;Lithuania;Austria;United Kingdom;Italy;Switzerland;France;Canada;Belgium;Poland;Denmark;Australia;Norway;Germany;Latvia;Netherlands;Sweden | ||
| 34 | EUCTR2021-001253-32-NL (EUCTR) | 11/04/2022 | 19/01/2022 | A Study to Evaluate the Efficacy, Safety and Tolerability of HZN-825 in Subjects with Idiopathic Pulmonary Fibrosis | A Phase 2b Randomized, Double-blind, Placebo-controlled, Repeat-dose, Multicenter Trial to Evaluate the Efficacy, Safety and Tolerability of HZN-825 in Subjects with Idiopathic Pulmonary Fibrosis | Idiopathic Pulmonary Fibrosis MedDRA version: 21.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Code: HZN-825 INN or Proposed INN: HZN-825 Other descriptive name: SAR100842 | Horizon Therapeutics Ireland DAC | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 360 | Phase 2 | United States;Taiwan;Greece;Spain;Turkey;Chile;United Kingdom;Italy;France;Mexico;Canada;Argentina;Belgium;Poland;Australia;South Africa;Netherlands;Germany;Korea, Republic of | ||
| 35 | EUCTR2021-001253-32-GR (EUCTR) | 04/03/2022 | 27/12/2021 | A Study to Evaluate the Efficacy, Safety and Tolerability of HZN-825 in Subjects with Idiopathic Pulmonary Fibrosis | A Phase 2b Randomized, Double-blind, Placebo-controlled, Repeat-dose, Multicenter Trial to Evaluate the Efficacy, Safety and Tolerability of HZN-825 in Subjects with Idiopathic Pulmonary Fibrosis | Idiopathic Pulmonary Fibrosis MedDRA version: 21.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Code: HZN-825 INN or Proposed INN: HZN-825 Other descriptive name: SAR100842 | Horizon Therapeutics Ireland DAC | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 360 | Phase 2 | United States;Taiwan;Greece;Spain;Turkey;Chile;United Kingdom;Italy;France;Mexico;Canada;Argentina;Belgium;Poland;Australia;South Africa;Germany;Netherlands;Korea, Republic of | ||
| 36 | NCT05154240 (ClinicalTrials.gov) | February 21, 2022 | 17/11/2021 | A Phase 1, Evaluate the Safety, Tolerability, and Pharmacokinetics of INS018_055 in Healthy Subjects | A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Oral Single and Multiple Ascending Doses, Parallel Group Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of INS018_055 in Healthy Subjects | Idiopathic Pulmonary Fibrosis | Drug: INS018_055;Drug: Placebo | InSilico Medicine Hong Kong Limited | NULL | Recruiting | 18 Years | 55 Years | All | 80 | Phase 1 | New Zealand |
| 37 | EUCTR2021-001253-32-ES (EUCTR) | 16/02/2022 | 07/12/2021 | A Study to Evaluate the Efficacy, Safety and Tolerability of HZN-825 in Subjects with Idiopathic Pulmonary Fibrosis | A Phase 2b Randomized, Double-blind, Placebo-controlled, Repeat-dose, Multicenter Trial to Evaluate the Efficacy, Safety and Tolerability of HZN-825 in Subjects with Idiopathic Pulmonary Fibrosis | Idiopathic Pulmonary Fibrosis MedDRA version: 21.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Code: HZN-825 INN or Proposed INN: HZN-825 Other descriptive name: SAR100842 | Horizon Therapeutics Ireland DAC | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 360 | Phase 2 | United States;Taiwan;Greece;Spain;Turkey;Chile;United Kingdom;Italy;France;Mexico;Canada;Argentina;Poland;Belgium;Australia;South Africa;Netherlands;Germany;Korea, Republic of | ||
| 38 | NCT05130970 (ClinicalTrials.gov) | January 27, 2022 | 12/11/2021 | CSL312 Safety, Pharmacokinetics, and Pharmacodynamics in Idiopathic Pulmonary Fibrosis | A Randomized, Double-blind, Placebo-controlled, Study to Investigate the Safety, Pharmacokinetics, and Pharmacodynamics of CSL312 in Subjects With Idiopathic Pulmonary Fibrosis | Idiopathic Pulmonary Fibrosis | Drug: CSL312;Drug: Placebo | CSL Behring | NULL | Recruiting | 40 Years | N/A | All | 80 | Phase 2 | United States;Australia;Austria;Belgium;Canada;Denmark;Germany;Poland;Spain;United Kingdom |
| 39 | JPRN-jRCT2051210169 | 16/01/2022 | 05/02/2022 | A Phase 3, Randomized, Double-Blind, Placebo-Controlled Efficacy and Safety Study of Pamrevlumab in Subjects with Idiopathic Pulmonary Fibrosis (IPF) | A Phase 3, Randomized, Double-Blind, Placebo-Controlled Efficacy and Safety Study of Pamrevlumab in Subjects with Idiopathic Pulmonary Fibrosis (IPF) | Idiopathic Pulmonary Fibrosis | Pamrevlumab or placebo, 30 mg/kg, IV, Day 1 and every 3 weeks thereafter, up to Week 48, for a total of up to 17 infusions. | Tracy Ganske | NULL | Recruiting | >= 40age old | <= 85age old | Both | 34 | Phase 3 | United States;Argentina;Chile;Russia;Australia;Taiwan;Hong Kong;South Korea;the People's Republic of China;Japan |
| 40 | NCT03720483 (ClinicalTrials.gov) | January 2022 | 18/7/2018 | Inhaled NAC in Treatment of IPF | Pilot Study to Evaluate Inhaled N-Acetylcysteine in Pulmonary Fibrosis | Idiopathic Pulmonary Fibrosis (IPF) | Drug: N-acetyl cysteine then Placebo;Drug: Placebo then N-acetyl cysteine | University of Colorado, Denver | NULL | Withdrawn | 40 Years | 75 Years | All | 0 | Phase 1/Phase 2 | United States |
| 41 | EUCTR2020-001429-30-AT (EUCTR) | 29/12/2021 | 04/01/2021 | A Study to Evaluate Long Term Safety and Efficacy of Recombinant Human Pentraxin-2 (rhPTX-2; PRM-151) in Patients with Idiopathic Pulmonary Fibrosis | A PHASE III OPEN-LABEL EXTENSION STUDY TO EVALUATE LONG-TERM SAFETY AND EFFICACY OF PRM-151 IN PATIENTS WITH IDIOPATHIC PULMONARY FIBROSIS (IPF) | Idiopathic pulmonary fibrosis (IPF) MedDRA version: 21.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: Recombinant human Pentraxin-2 (PRM-151) Product Code: RO7490677 160mg/8mL INN or Proposed INN: Recombinant human Pentraxin-2 Other descriptive name: PRM-151 Product Name: Recombinant human Pentraxin-2 (PRM-151) Product Code: RO7490677 320mg/16mL (2nd generation) INN or Proposed INN: Recombinant human Pentraxin-2 Other descriptive name: PRM-151 | F. Hoffmann-La Roche Ltd | NULL | Not Recruiting | Female: yes Male: yes | 700 | Phase 3 | Portugal;United States;Hong Kong;Taiwan;Greece;Spain;Ukraine;Russian Federation;Israel;Italy;Switzerland;France;Denmark;Peru;Australia;South Africa;Netherlands;China;Korea, Republic of;Czechia;Finland;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Belgium;Brazil;Poland;Singapore;Norway;Germany;New Zealand;Sweden | ||
| 42 | JPRN-jRCT2051210129 | 05/12/2021 | 05/12/2021 | A PHASE III RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED TRIAL TO EVALUATE THE EFFICACY AND SAFETY OF PRM-151(rhPTX-2) IN PATIENTS WITH IDIOPATHIC PULMONARY FIBROSIS (STARSCAPE) | A PHASE III RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED TRIAL TO EVALUATE THE EFFICACY AND SAFETY OF PRM-151(rhPTX-2) IN PATIENTS WITH IDIOPATHIC PULMONARY FIBROSIS (STARSCAPE) - WA42293 | Idiopathic pulmonary fibrosis | RO7490677 (PRM-151) is administered intravenously at 10 mg / kg every 4 weeks for 48 weeks. | Makino Ryoko | NULL | Recruiting | >= 40age old | <= 85age old | Both | 60 | Phase 3 | Spain;Sweden;Japan;Argentina;Australia;Austria;Belgium;Brazil;Canada;China;Czech Republic;Denmark;Finland;France;Germany;Greece;Hong Kong;Hungary;Israel;Italy;South Korea;Mexico;Netherlands;New Zealand;Norway;Peru;Poland;Portugal;Russian Federation;Singapore;South Africa |
| 43 | NCT05134727 (ClinicalTrials.gov) | November 18, 2021 | 15/11/2021 | Assess the Safety, Tolerability and Pharmacokinetics of AZD5055 Following Single and Multiple Ascending Doses in Healthy Participants | A Double-blind, Randomized, Placebo-controlled Study in Healthy Volunteers to Investigate the Safety, Tolerability and Pharmacokinetics of Oral AZD5055 Following Single and Multiple Ascending Doses | Idiopathic Pulmonary Fibrosis | Drug: AZD5055;Drug: Placebo | AstraZeneca | NULL | Recruiting | 18 Years | 55 Years | All | 90 | Phase 1 | United States |
| 44 | NCT05119972 (ClinicalTrials.gov) | October 21, 2021 | 9/10/2021 | Tolerability, Pharmacokinetics and Efficacy of ZSP1603 in Patients With Idiopathic Pulmonary Fibrosis (IPF) | A Multi-center, Phase Ib/IIa Clinical Trial to Evaluate the Tolerability, PK and Efficacy of ZSP1603 in Patients With Idiopathic Pulmonary Fibrosis | Idiopathic Pulmonary Fibrosis (IPF) | Drug: ZSP1603;Drug: Placebo | Guangdong Raynovent Biotech Co., Ltd | NULL | Recruiting | 40 Years | N/A | All | 36 | Phase 1/Phase 2 | China |
| 45 | NCT05022771 (ClinicalTrials.gov) | October 14, 2021 | 20/8/2021 | A First in Human Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Immunogenicity of PMG1015 | A Phase 1A, First in Human, Randomized, Double-blind, Placebo-controlled, Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Immunogenicity of PMG1015 in Healthy Volunteers | Idiopathic Pulmonary Fibrosis | Drug: PMG1015 Dose 1;Drug: PMG1015 Dose 2;Drug: PMG1015 Dose 3;Drug: PMG1015 Dose 4;Drug: PMG1015 Dose 5;Drug: PMG1015 Dose 6;Drug: Placebo;Drug: PMG1015 Dose 7 | Pulmongene Ltd. | NULL | Completed | 18 Years | 60 Years | All | 54 | Phase 1 | Australia |
| 46 | EUCTR2020-001429-30-NO (EUCTR) | 15/09/2021 | 07/01/2021 | A Study to Evaluate Long Term Safety and Efficacy of Recombinant Human Pentraxin-2 (rhPTX-2; PRM-151) in Patients with Idiopathic Pulmonary Fibrosis | A PHASE III OPEN-LABEL EXTENSION STUDY TO EVALUATE LONG-TERM SAFETY AND EFFICACY OF PRM-151 IN PATIENTS WITH IDIOPATHIC PULMONARY FIBROSIS (IPF) | Idiopathic pulmonary fibrosis (IPF) MedDRA version: 21.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: Recombinant human Pentraxin-2 (PRM-151) Product Code: RO7490677/F01-01 INN or Proposed INN: Recombinant human Pentraxin-2 Other descriptive name: PRM-151 Product Name: Recombinant human Pentraxin-2 (PRM-151) Product Code: RO7490677/F01-02 INN or Proposed INN: Recombinant human Pentraxin-2 Other descriptive name: PRM-151 | F. Hoffmann-La Roche Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 700 | Phase 3 | Portugal;United States;Hong Kong;Taiwan;Greece;Spain;Ukraine;Russian Federation;Israel;Switzerland;Italy;France;Peru;Australia;Denmark;South Africa;Netherlands;China;Korea, Republic of;Czechia;Finland;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Singapore;Germany;Norway;New Zealand;Sweden | ||
| 47 | NCT05032066 (ClinicalTrials.gov) | August 25, 2021 | 27/8/2021 | A Multicenter Trial to Evaluate the Efficacy, Safety and Tolerability of HZN-825 in Subjects With Idiopathic Pulmonary Fibrosis | A Phase 2b Randomized, Double-blind, Placebo-controlled, Repeat-dose, Multicenter Trial to Evaluate the Efficacy, Safety and Tolerability of HZN-825 in Subjects With Idiopathic Pulmonary Fibrosis | Idiopathic Pulmonary Fibrosis | Drug: HZN-825;Drug: Placebo | Horizon Therapeutics Ireland DAC | NULL | Recruiting | 18 Years | N/A | All | 135 | Phase 2 | United States;Argentina;Australia;Canada;Chile;France;Germany;Greece;Italy;Japan;Korea, Republic of;Mexico;Netherlands;Poland;South Africa;Spain;Taiwan;Turkey |
| 48 | NCT04986540 (ClinicalTrials.gov) | August 10, 2021 | 27/7/2021 | A Trial of SHR - 1906 in Healthy Subjects | A Phase 1, Randomized, Double-Blind, Placebo-Controlled Dose Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of Single IV Infusion of SHR-1906 in Healthy Subjects | Idiopathic Pulmonary Fibrosis | Drug: SHR-1906;Placebo | Guangdong Hengrui Pharmaceutical Co., Ltd | NULL | Completed | 18 Years | 55 Years | All | 72 | Phase 1 | China |
| 49 | EUCTR2020-000791-38-DK (EUCTR) | 06/08/2021 | 11/01/2021 | A Study to Evaluate the Efficacy and Safety of PRM-151 in Patients with Idiopathic Pulmonary Fibrosis | A PHASE III RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED TRIAL TO EVALUATE THE EFFICACY AND SAFETY OF PRM-151 IN PATIENTS WITH IDIOPATHIC PULMONARY FIBROSIS | Idiopathic pulmonary fibrosis (IPF) MedDRA version: 21.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: Recombinant human Pentraxin-2 (PRM-151) Product Code: RO7490677 160mg/8mL INN or Proposed INN: Recombinant human Pentraxin-2 Other descriptive name: PRM-151 Product Name: Recombinant human Pentraxin-2 (PRM-151) Product Code: RO7490677 320mg/16mL (2nd generation) INN or Proposed INN: Recombinant human Pentraxin-2 Other descriptive name: PRM-151 | F. Hoffmann-La Roche Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 658 | Phase 3 | Portugal;United States;Hong Kong;Taiwan;Greece;Spain;Ukraine;Russian Federation;Israel;Italy;Switzerland;France;Peru;Australia;Denmark;South Africa;Netherlands;China;Korea, Republic of;Czechia;Finland;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Belgium;Brazil;Poland;Singapore;Norway;Germany;New Zealand;Sweden | ||
| 50 | NCT04888715 (ClinicalTrials.gov) | July 23, 2021 | 28/4/2021 | To Evaluate Drug-drug Interactions Between DWN12088 and Pirfenidone or Nintedanib in Healthy Volunteers | An Open Label, 2-part, One-sequence, 3-period Study to Evaluate Drug-drug Interactions Between DWN12088 and Pirfenidone or Nintedanib in Healthy Volunteers | Idiopathic Pulmonary Fibrosis | Drug: DWN12088;Drug: Pirfenidone;Drug: Nintedanib | Daewoong Pharmaceutical Co. LTD. | NULL | Completed | 19 Years | 55 Years | All | 48 | Phase 1 | Korea, Republic of |
| 51 | JPRN-jRCT2071210016 | 11/07/2021 | 28/04/2021 | Drug-drug interaction study of TAS-115 with lansoprazole in healthy subjects | Drug-drug interaction study of TAS-115 with lansoprazole in healthy subjects | Idiopathic pulmonary fibrosis | Day 1:TAS-115 will be orally administered. Day11-Day14:Lansoprazole will be orally administered once a day. Day 15:Lansoprazole will be orally administered and TAS-115 will be orally administered 1 hour later. | Huang Jinhong | NULL | Complete | >= 20age old | < 40age old | Male | 14 | Phase 1 | Japan |
| 52 | EUCTR2020-001429-30-DK (EUCTR) | 07/07/2021 | 12/01/2021 | A Study to Evaluate Long Term Safety and Efficacy of Recombinant Human Pentraxin-2 (rhPTX-2; PRM-151) in Patients with Idiopathic Pulmonary Fibrosis | A PHASE III OPEN-LABEL EXTENSION STUDY TO EVALUATE LONG-TERM SAFETY AND EFFICACY OF PRM-151 IN PATIENTS WITH IDIOPATHIC PULMONARY FIBROSIS (IPF) | Idiopathic pulmonary fibrosis (IPF) MedDRA version: 21.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: Recombinant human Pentraxin-2 (PRM-151) Product Code: RO7490677/F01-01 INN or Proposed INN: Recombinant human Pentraxin-2 Other descriptive name: PRM-151 Product Name: Recombinant human Pentraxin-2 (PRM-151) Product Code: RO7490677/F01-02 INN or Proposed INN: Recombinant human Pentraxin-2 Other descriptive name: PRM-151 | F. Hoffmann-La Roche Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 700 | Phase 3 | Portugal;United States;Hong Kong;Taiwan;Greece;Spain;Ukraine;Russian Federation;Israel;Switzerland;Italy;France;Peru;Australia;Denmark;South Africa;Netherlands;China;Korea, Republic of;Czechia;Finland;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Singapore;Norway;Germany;New Zealand;Sweden | ||
| 53 | NCT04888728 (ClinicalTrials.gov) | June 30, 2021 | 28/4/2021 | To Evaluate Drug-drug Interactions Between DWN12088 and Nebivolol or Paroxetine in Healthy Volunteers | An Open Label, 2-part, One-sequence, 3-period Study to Evaluate Drug-drug Interactions Between DWN12088 and Nebivolol or Paroxetine in Healthy Male Volunteers | Idiopathic Pulmonary Fibrosis | Drug: DWN12088;Drug: Nebivolol;Drug: Paroxetine | Daewoong Pharmaceutical Co. LTD. | NULL | Completed | 20 Years | 55 Years | Male | 24 | Phase 1 | Korea, Republic of |
| 54 | NCT05383131 (ClinicalTrials.gov) | June 23, 2021 | 12/5/2022 | To Evaluate Drug-drug Interactions Between HEC585 and Pirfenidone or Nintedanib in Healthy Volunteers | A Single Center, Open Label Study to Evaluate Drug-drug Interactions Between HEC585 and Pirfenidone or Nintedanib in Healthy Volunteers | Idiopathic Pulmonary Fibrosis | Drug: HEC585;Drug: Pirfenidone;Drug: Nintedanib | Sunshine Lake Pharma Co., Ltd. | NULL | Completed | 18 Years | 45 Years | All | 33 | Phase 1 | China |
| 55 | NCT04965298 (ClinicalTrials.gov) | June 16, 2021 | 7/7/2021 | Treating People With Idiopathic Pulmonary Fibrosis With the Addition of Lansoprazole | The Effectiveness and Risks of Treating People With Idiopathic Pulmonary Fibrosis With the Addition of Lansoprazole: a Randomised Placebo-controlled Multi-centre Clinical Trial | Idiopathic Pulmonary Fibrosis | Drug: Lansoprazole;Other: Matched placebo | Norfolk and Norwich University Hospitals NHS Foundation Trust | Norwich Clinical Trials Unit | Recruiting | 40 Years | N/A | All | 298 | Phase 3 | United Kingdom |
| 56 | NCT04708782 (ClinicalTrials.gov) | June 1, 2021 | 12/1/2021 | Study of Efficacy and Safety of Inhaled Treprostinil in Subjects With Idiopathic Pulmonary Fibrosis | A Randomized, Double-blind, Placebo-controlled, Phase 3 Study of the Efficacy and Safety of Inhaled Treprostinil in Subjects With Idiopathic Pulmonary Fibrosis | Idiopathic Pulmonary Fibrosis;Interstitial Lung Disease | Drug: Placebo;Drug: Inhaled Treprostinil;Device: Treprostinil Ultrasonic Nebulizer | United Therapeutics | NULL | Recruiting | 40 Years | N/A | All | 396 | Phase 3 | United States |
| 57 | EUCTR2020-000791-38-DE (EUCTR) | 28/05/2021 | 02/12/2020 | A Study to Evaluate the Efficacy and Safety of PRM-151 in Patients with Idiopathic Pulmonary Fibrosis | A PHASE III RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED TRIAL TO EVALUATE THE EFFICACY AND SAFETY OF PRM-151 IN PATIENTS WITH IDIOPATHIC PULMONARY FIBROSIS | Idiopathic pulmonary fibrosis (IPF) MedDRA version: 21.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: Recombinant human Pentraxin-2 (PRM-151) Product Code: RO7490677 160 mg/8mL INN or Proposed INN: Recombinant human Pentraxin-2 Other descriptive name: PRM-151 Product Name: Recombinant human Pentraxin-2 (PRM-151) Product Code: RO7490677 320mg/16mL (2nd generation) INN or Proposed INN: Recombinant human Pentraxin-2 Other descriptive name: PRM-151 | F. Hoffmann-La Roche Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 658 | Phase 3 | Portugal;United States;Hong Kong;Taiwan;Greece;Spain;Ukraine;Russian Federation;Israel;Italy;Switzerland;France;Denmark;Peru;Australia;South Africa;Netherlands;China;Korea, Republic of;Czechia;Finland;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Belgium;Brazil;Poland;Singapore;Norway;Germany;New Zealand;Sweden | ||
| 58 | EUCTR2020-001429-30-DE (EUCTR) | 26/05/2021 | 03/12/2020 | A Study to Evaluate Long Term Safety and Efficacy of Recombinant Human Pentraxin-2 (rhPTX-2; PRM-151) in Patients with Idiopathic Pulmonary Fibrosis | A PHASE III OPEN-LABEL EXTENSION STUDY TO EVALUATE LONG-TERM SAFETY AND EFFICACY OF PRM-151 IN PATIENTS WITH IDIOPATHIC PULMONARY FIBROSIS (IPF) | Idiopathic pulmonary fibrosis (IPF) MedDRA version: 21.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: Recombinant human Pentraxin-2 (PRM-151) Product Code: RO7490677 160mg/8mL INN or Proposed INN: Recombinant human Pentraxin-2 Other descriptive name: PRM-151 Product Name: Recombinant human Pentraxin-2 (PRM-151) Product Code: RO7490677 320mg/16mL (1st generation) INN or Proposed INN: Recombinant human Pentraxin-2 Other descriptive name: PRM-151 Product Name: Recombinant human Pentraxin-2 (PRM-151) Product Code: RO7490677 320mg/16mL (2nd generation) INN or Proposed INN: Recombinant human Pentraxin-2 Other descriptive name: PRM-151 | F. Hoffmann-La Roche Ltd | NULL | Not Recruiting | Female: yes Male: yes | 700 | Phase 3 | Portugal;United States;Hong Kong;Taiwan;Greece;Spain;Ukraine;Russian Federation;Israel;Italy;Switzerland;France;Denmark;Peru;Australia;South Africa;Netherlands;China;Korea, Republic of;Czechia;Finland;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Belgium;Brazil;Poland;Singapore;Norway;Germany;New Zealand;Sweden | ||
| 59 | EUCTR2020-000791-38-NO (EUCTR) | 25/05/2021 | 08/01/2021 | A Study to Evaluate the Efficacy and Safety of PRM-151 in Patients with Idiopathic Pulmonary Fibrosis | A PHASE III RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED TRIAL TO EVALUATE THE EFFICACY AND SAFETY OF PRM-151 IN PATIENTS WITH IDIOPATHIC PULMONARY FIBROSIS | Idiopathic pulmonary fibrosis (IPF) MedDRA version: 21.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: Recombinant human Pentraxin-2 (PRM-151) Product Code: RO7490677 INN or Proposed INN: Recombinant human Pentraxin-2 Other descriptive name: PRM-151 | F. Hoffmann-La Roche Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 658 | Phase 3 | Korea, Republic of;Czechia;Finland;Portugal;United States;Hong Kong;Taiwan;Greece;Spain;Ukraine;Russian Federation;Israel;Switzerland;Italy;France;Peru;Australia;Denmark;South Africa;Netherlands;China;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Singapore;Norway;Germany;New Zealand;Sweden | ||
| 60 | NCT05657184 (ClinicalTrials.gov) | May 14, 2021 | 15/11/2022 | Treatment of Idiopathic Pulmonary Fibrosis(IPF) by REGEND001 | An Open-labelled Clinical Study to Explore the Safety, Tolerability and Preliminary Efficacy of REGEND001 Autologous Therapy Product for Treatment of Idiopathic Pulmonary Fibrosis (IPF). | Idiopathic Pulmonary Fibrosis | Drug: REGEND001 Autologous Therapy Product | Regend Therapeutics | Peking Union Medical College Hospital;Ruijin Hospital;The First Affiliated Hospital of Guangzhou Medical University;Regend Therapeutics XLotus (Jiangxi) Co, Ltd. | Recruiting | 50 Years | 75 Years | All | 24 | Phase 1/Phase 2 | China |
| 61 | NCT04931147 (ClinicalTrials.gov) | May 13, 2021 | 4/6/2021 | A 3-part Study to Evaluate Safety, Tolerability, Food Effect and Drug-drug Interactions of RXC007 in Healthy Volunteers | A Randomised, Double-blind, Placebo-controlled, SAD/MAD First-in-human, Phase 1 Study to Evaluate the Safety, Tolerability and Pharmacokinetics of RXC007 Including Evaluation of Drug-Drug Interaction and Food Effect in Male Participants | Fibrosis;Inflammation;Idiopathic Pulmonary Fibrosis;Non-alcoholic Steatohepatitis;Liver Diseases;Kidney Diseases | Drug: RXC007;Drug: RXC007 Matching Placebo | Redx Pharma Plc | Simbec Research | Recruiting | 18 Years | 55 Years | Male | 80 | Phase 1 | United Kingdom |
| 62 | EUCTR2020-001429-30-NL (EUCTR) | 07/05/2021 | 01/02/2021 | A Study to Evaluate Long Term Safety and Efficacy of Recombinant Human Pentraxin-2 (rhPTX-2; PRM-151) in Patients with Idiopathic Pulmonary Fibrosis | A PHASE III OPEN-LABEL EXTENSION STUDY TO EVALUATE LONG-TERM SAFETY AND EFFICACY OF PRM-151 IN PATIENTS WITH IDIOPATHIC PULMONARY FIBROSIS (IPF) | Idiopathic pulmonary fibrosis (IPF) MedDRA version: 21.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: Recombinant human Pentraxin-2 (PRM-151) Product Code: Zinpetraxin Alfa INN or Proposed INN: Recombinant human Pentraxin-2 Other descriptive name: PRM-151 | F. Hoffmann-La Roche Ltd | NULL | Not Recruiting | Female: yes Male: yes | 658 | Phase 3 | Portugal;United States;Hong Kong;Taiwan;Greece;Spain;Ukraine;Russian Federation;Israel;Italy;Switzerland;France;Denmark;Peru;Australia;South Africa;Netherlands;China;Korea, Republic of;Czechia;Finland;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Belgium;Brazil;Poland;Singapore;Norway;Germany;New Zealand;Sweden | ||
| 63 | EUCTR2020-001429-30-SE (EUCTR) | 07/05/2021 | 04/12/2020 | A Study to Evaluate Long Term Safety and Efficacy of Recombinant Human Pentraxin-2 (rhPTX-2; PRM-151) in Patients with Idiopathic Pulmonary Fibrosis | A PHASE III OPEN-LABEL EXTENSION STUDY TO EVALUATE LONG-TERM SAFETY AND EFFICACY OF PRM-151 IN PATIENTS WITH IDIOPATHIC PULMONARY FIBROSIS (IPF) | Idiopathic pulmonary fibrosis (IPF) MedDRA version: 21.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: Recombinant human Pentraxin-2 (PRM-151) Product Code: RO7490677/F01-01 INN or Proposed INN: Recombinant human Pentraxin-2 Other descriptive name: PRM-151 Product Name: Recombinant human Pentraxin-2 (PRM-151) Product Code: RO7490677/F01-02 INN or Proposed INN: Recombinant human Pentraxin-2 Other descriptive name: PRM-151 Product Name: Recombinant human Pentraxin-2 (PRM-151) Product Code: RO7490677/F01-03 INN or Proposed INN: Recombinant human Pentraxin-2 Other descriptive name: PRM-151 | F. Hoffmann-La Roche Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 700 | Phase 3 | Portugal;United States;Hong Kong;Taiwan;Greece;Spain;Ukraine;Russian Federation;Israel;Switzerland;Italy;France;Peru;Australia;Denmark;South Africa;Netherlands;China;Korea, Republic of;Czechia;Finland;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Singapore;Norway;Germany;New Zealand;Sweden | ||
| 64 | EUCTR2020-000697-22-IE (EUCTR) | 04/05/2021 | 02/12/2020 | A study to compare the use of Pamrevlumab with Placebo in patients with Idiopathic Pulmonary Fibrosis. | Zephyrus II: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Efficacy and Safety Study of Pamrevlumab in Subjects with Idiopathic Pulmonary Fibrosis (IPF). | Idiopathic Pulmonary Fibrosis MedDRA version: 21.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17] | Product Name: Pamrevlumab Product Code: FG-3019 INN or Proposed INN: PAMREVLUMAB | FibroGen, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 340 | Phase 3 | Serbia;Czechia;Spain;Ukraine;Ireland;Lebanon;Colombia;United Kingdom;Switzerland;Italy;France;Hungary;Mexico;Poland;Brazil;Dominican Republic;Peru;Denmark;Georgia;Netherlands;Germany | ||
| 65 | EUCTR2020-000791-38-NL (EUCTR) | 29/04/2021 | 21/01/2021 | A Study to Evaluate the Efficacy and Safety of PRM-151 in Patients with Idiopathic Pulmonary Fibrosis | A PHASE III RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED TRIAL TO EVALUATE THE EFFICACY AND SAFETY OF PRM-151 IN PATIENTS WITH IDIOPATHIC PULMONARY FIBROSIS | Idiopathic pulmonary fibrosis (IPF) MedDRA version: 21.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: Recombinant human Pentraxin-2 (PRM-151) Product Code: Zinpetraxin Alfa INN or Proposed INN: Recombinant human Pentraxin-2 Other descriptive name: PRM-151 | F. Hoffmann-La Roche Ltd | NULL | Not Recruiting | Female: yes Male: yes | 658 | Phase 3 | Portugal;United States;Hong Kong;Taiwan;Greece;Spain;Ukraine;Russian Federation;Israel;Italy;Switzerland;France;Denmark;Peru;Australia;South Africa;Netherlands;China;Korea, Republic of;Czechia;Finland;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Belgium;Brazil;Poland;Singapore;Norway;Germany;New Zealand;Sweden | ||
| 66 | EUCTR2020-005103-39-PL (EUCTR) | 24/04/2021 | 24/03/2021 | Access to Pirfenidone Solution for Inhalation (AP01) for Treatment of Progressive, Fibrosing Interstitial Lung Diseases, including Idiopathic Pulmonary Fibrosis | Access to Pirfenidone Solution for Inhalation (AP01) for Treatment of Progressive, Fibrosing Interstitial Lung Diseases, including Idiopathic Pulmonary Fibrosis | Interstitial Lung Diseases (ILD), including but not limited to idiopathic pulmonary fibrosis (IPF) MedDRA version: 21.1;Level: PT;Classification code 10022611;Term: Interstitial lung disease;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: Pirfenidone Solution for Inhalation Product Code: AP01 INN or Proposed INN: PIRFENIDONE Other descriptive name: NA | Avalyn Pharma, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 100 | Phase 2 | Czechia;Czech Republic;Poland;Australia;Netherlands;United Kingdom;New Zealand | ||
| 67 | EUCTR2020-005103-39-NL (EUCTR) | 21/04/2021 | 07/01/2021 | Access to Pirfenidone Solution for Inhalation (AP01) for Treatment of Progressive, Fibrosing Interstitial Lung Diseases, including Idiopathic Pulmonary Fibrosis | Access to Pirfenidone Solution for Inhalation (AP01) for Treatment of Progressive, Fibrosing Interstitial Lung Diseases, including Idiopathic Pulmonary Fibrosis | Interstitial Lung Diseases (ILD), including but not limited to idiopathic pulmonary fibrosis (IPF) MedDRA version: 21.1;Level: PT;Classification code 10022611;Term: Interstitial lung disease;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: Pirfenidone Solution for Inhalation Product Code: AP01 INN or Proposed INN: PIRFENIDONE Other descriptive name: NA | Avalyn Pharma, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 100 | Phase 2 | Czechia;Czech Republic;Poland;Australia;Netherlands;United Kingdom;New Zealand | ||
| 68 | EUCTR2020-005103-39-CZ (EUCTR) | 16/04/2021 | 22/12/2020 | Access to Pirfenidone Solution for Inhalation (AP01) for Treatment of Progressive, Fibrosing Interstitial Lung Diseases, including Idiopathic Pulmonary Fibrosis | Access to Pirfenidone Solution for Inhalation (AP01) for Treatment of Progressive, Fibrosing Interstitial Lung Diseases, including Idiopathic Pulmonary Fibrosis | Interstitial Lung Diseases (ILD), including but not limited to idiopathic pulmonary fibrosis (IPF) MedDRA version: 21.1;Level: PT;Classification code 10022611;Term: Interstitial lung disease;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: Pirfenidone Solution for Inhalation Product Code: AP01 INN or Proposed INN: PIRFENIDONE Other descriptive name: NA | Avalyn Pharma, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 100 | Phase 2 | Czechia;Czech Republic;Poland;Australia;Netherlands;United Kingdom;New Zealand | ||
| 69 | EUCTR2020-000791-38-SE (EUCTR) | 14/04/2021 | 27/11/2020 | A Study to Evaluate the Efficacy and Safety of PRM-151 in Patients with Idiopathic Pulmonary Fibrosis | A PHASE III RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED TRIAL TO EVALUATE THE EFFICACY AND SAFETY OF PRM-151 IN PATIENTS WITH IDIOPATHIC PULMONARY FIBROSIS | Idiopathic pulmonary fibrosis (IPF) MedDRA version: 21.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: Recombinant human Pentraxin-2 (PRM-151) Product Code: RO7490677 160mg/8mL INN or Proposed INN: Recombinant human Pentraxin-2 Other descriptive name: PRM-151 Product Name: Recombinant human Pentraxin-2 (PRM-151) Product Code: RO7490677 320mg/16mL (2nd generation) INN or Proposed INN: Recombinant human Pentraxin-2 Other descriptive name: PRM-151 | F. Hoffmann-La Roche Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 658 | Phase 3 | Portugal;United States;Hong Kong;Taiwan;Greece;Spain;Ukraine;Russian Federation;Israel;Italy;Switzerland;France;Peru;Australia;Denmark;South Africa;Netherlands;China;Korea, Republic of;Czechia;Finland;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Singapore;Germany;Norway;New Zealand;Sweden | ||
| 70 | EUCTR2020-000697-22-PL (EUCTR) | 13/04/2021 | 03/12/2020 | A study to compare the use of Pamrevlumab with Placebo in patients with Idiopathic Pulmonary Fibrosis. | Zephyrus II: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Efficacy and Safety Study of Pamrevlumab in Subjects with Idiopathic Pulmonary Fibrosis (IPF). | Idiopathic Pulmonary Fibrosis MedDRA version: 21.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17] | Product Name: Pamrevlumab Product Code: FG-3019 INN or Proposed INN: PAMREVLUMAB | FibroGen, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 340 | Phase 3 | Serbia;Spain;Ukraine;Lebanon;Ireland;Colombia;Italy;India;France;Peru;Denmark;Netherlands;Czechia;United Kingdom;Hungary;Czech Republic;Mexico;Belgium;Brazil;Poland;Dominican Republic;Bulgaria;Georgia;Germany;Norway | ||
| 71 | EUCTR2019-004167-45-CZ (EUCTR) | 12/04/2021 | 18/06/2020 | A study to test how taking BI 1015550 for 12 weeks affects lungfunction in people with idiopathic pulmonary fibrosis (IPF). | A randomised, double-blind, placebo-controlled parallel groupstudy in IPF patients over 12 weeks evaluating efficacy, safety andtolerability of BI 1015550 taken orally. | Idiopathic Pulmonary Fibrosis MedDRA version: 21.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Code: BI 1015550 INN or Proposed INN: BI 1015550 Other descriptive name: BI 1015550 Product Code: BI 1015550 INN or Proposed INN: BI 1015550 Other descriptive name: BI 1015550 | Boehringer Ingelheim RCV GmbH & Co KG | NULL | Not Recruiting | Female: yes Male: yes | 150 | Phase 2 | United States;Slovakia;Greece;Spain;Ukraine;Russian Federation;Chile;Italy;Denmark;Australia;Netherlands;China;Korea, Republic of;Czechia;Finland;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Germany;Japan | ||
| 72 | EUCTR2020-001429-30-PT (EUCTR) | 09/04/2021 | 14/12/2020 | A Study to Evaluate Long Term Safety and Efficacy of Recombinant Human Pentraxin-2 (rhPTX-2; PRM-151) in Patients with Idiopathic Pulmonary Fibrosis | A PHASE III OPEN-LABEL EXTENSION STUDY TO EVALUATE LONG-TERM SAFETY AND EFFICACY OF PRM-151 IN PATIENTS WITH IDIOPATHIC PULMONARY FIBROSIS (IPF) | Idiopathic pulmonary fibrosis (IPF) MedDRA version: 21.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: Recombinant human Pentraxin-2 (PRM-151) Product Code: RO7490677 INN or Proposed INN: Recombinant human Pentraxin-2 Other descriptive name: PRM-151 | F. Hoffmann-La Roche Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 700 | Phase 3 | Portugal;United States;Hong Kong;Taiwan;Greece;Spain;Ukraine;Russian Federation;Israel;Switzerland;Italy;France;Peru;Australia;Denmark;South Africa;Netherlands;China;Korea, Republic of;Czechia;Finland;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Singapore;Norway;Germany;New Zealand;Sweden | ||
| 73 | NCT04767815 (ClinicalTrials.gov) | March 22, 2021 | 15/2/2021 | To Evaluate Food Effect on the PK and Safety After Oral DWN12088 Administration in Healthy Adult Volunteers | A Randomized, Open-label, Single Dose, Crossover Study to Evaluate the Effect of Food on the Pharmacokinetics and Safety After Oral DWN12088 Administration in Healthy Adult Volunteers | Idiopathic Pulmonary Fibrosis | Drug: Diet A group;Drug: Diet B group;Drug: Diet C group | Daewoong Pharmaceutical Co. LTD. | NULL | Completed | 19 Years | 55 Years | All | 36 | Phase 1 | Korea, Republic of |
| 74 | NCT04552899 (ClinicalTrials.gov) | March 19, 2021 | 14/9/2020 | A Study to Evaluate the Efficacy and Safety of Recombinant Human Pentraxin-2 (rhPTX-2; PRM-151) in Participants With Idiopathic Pulmonary Fibrosis | A Phase III Randomized, Double-blind, Placebo Controlled Trial to Evaluate the Efficacy and Safety of PRM-151 in Patients With Idiopathic Pulmonary Fibrosis | Idiopathic Pulmonary Fibrosis | Drug: PRM-151 (Zinpentraxin Alfa);Drug: Placebo | Hoffmann-La Roche | NULL | Completed | 40 Years | 85 Years | All | 665 | Phase 3 | United States;Argentina;Australia;Austria;Belgium;Brazil;Canada;China;Czechia;Denmark;Finland;France;Germany;Greece;Hong Kong;Hungary;Israel;Italy;Japan;Korea, Republic of;Mexico;Netherlands;New Zealand;Norway;Poland;Portugal;Singapore;South Africa;Spain;Sweden;Switzerland;Taiwan;Turkey;Ukraine;United Kingdom;Peru;Puerto Rico;Russian Federation |
| 75 | EUCTR2020-000791-38-PT (EUCTR) | 19/03/2021 | 17/12/2020 | A Study to Evaluate the Efficacy and Safety of PRM-151 in Patients with Idiopathic Pulmonary Fibrosis | A PHASE III RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED TRIAL TO EVALUATE THE EFFICACY AND SAFETY OF PRM-151 IN PATIENTS WITH IDIOPATHIC PULMONARY FIBROSIS | Idiopathic pulmonary fibrosis (IPF) MedDRA version: 21.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: Recombinant human Pentraxin-2 (PRM-151) Product Code: RO7490677 INN or Proposed INN: Recombinant human Pentraxin-2 Other descriptive name: PRM-151 | F. Hoffmann-La Roche Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 658 | Phase 3 | Portugal;United States;Hong Kong;Taiwan;Greece;Spain;Ukraine;Russian Federation;Israel;Switzerland;Italy;France;Peru;Australia;Denmark;South Africa;Netherlands;China;Korea, Republic of;Czechia;Finland;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Singapore;Norway;Germany;New Zealand;Sweden | ||
| 76 | EUCTR2020-000791-38-FI (EUCTR) | 16/03/2021 | 09/12/2020 | A Study to Evaluate the Efficacy and Safety of PRM-151 in Patients with Idiopathic Pulmonary Fibrosis | A PHASE III RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED TRIAL TO EVALUATE THE EFFICACY AND SAFETY OF PRM-151 IN PATIENTS WITH IDIOPATHIC PULMONARY FIBROSIS | Idiopathic pulmonary fibrosis (IPF) MedDRA version: 21.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: Recombinant human Pentraxin-2 (PRM-151) Product Code: RO7490677 160 mg/8 ml INN or Proposed INN: Recombinant human Pentraxin-2 Other descriptive name: PRM-151 Product Name: Recombinant human Pentraxin-2 (PRM-151) Product Code: RO7490677 320 mg/16 ml (2nd generation) INN or Proposed INN: Recombinant human Pentraxin-2 Other descriptive name: PRM-151 | F. Hoffmann-La Roche Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 658 | Phase 3 | Portugal;United States;Hong Kong;Taiwan;Greece;Spain;Ukraine;Russian Federation;Israel;Italy;Switzerland;France;Denmark;Peru;Australia;South Africa;Netherlands;China;Korea, Republic of;Czechia;Finland;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Belgium;Brazil;Poland;Singapore;Norway;Germany;New Zealand;Sweden | ||
| 77 | EUCTR2020-001429-30-FR (EUCTR) | 15/03/2021 | 27/11/2020 | A Study to Evaluate Long Term Safety and Efficacy of Recombinant Human Pentraxin-2 (rhPTX-2; PRM-151) in Patients with Idiopathic Pulmonary Fibrosis | A PHASE III OPEN-LABEL EXTENSION STUDY TO EVALUATE LONG-TERM SAFETY AND EFFICACY OF PRM-151 IN PATIENTS WITH IDIOPATHIC PULMONARY FIBROSIS (IPF) | Idiopathic pulmonary fibrosis (IPF) MedDRA version: 21.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: Recombinant human Pentraxin-2 (PRM-151) Product Code: RO7490677 INN or Proposed INN: Recombinant human Pentraxin-2 Other descriptive name: PRM-151 | F. Hoffmann-La Roche Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 700 | Phase 3 | United States;Portugal;Taiwan;Hong Kong;Greece;Spain;Ukraine;Russian Federation;Israel;Switzerland;Italy;France;Denmark;Australia;Peru;South Africa;Netherlands;China;Korea, Republic of;Czechia;Finland;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Singapore;Germany;Norway;New Zealand;Sweden | ||
| 78 | EUCTR2020-001429-30-GR (EUCTR) | 18/02/2021 | 07/12/2020 | A Study to Evaluate Long Term Safety and Efficacy of Recombinant Human Pentraxin-2 (rhPTX-2; PRM-151) in Patients with Idiopathic Pulmonary Fibrosis | A PHASE III OPEN-LABEL EXTENSION STUDY TO EVALUATE LONG-TERM SAFETY AND EFFICACY OF PRM-151 IN PATIENTS WITH IDIOPATHIC PULMONARY FIBROSIS (IPF) | Idiopathic pulmonary fibrosis (IPF) MedDRA version: 21.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: Recombinant human Pentraxin-2 (PRM-151) Product Code: RO7490677/F01-01 INN or Proposed INN: Recombinant human Pentraxin-2 Other descriptive name: PRM-151 Product Name: Recombinant human Pentraxin-2 (PRM-151) Product Code: RO7490677/F01-02 INN or Proposed INN: Recombinant human Pentraxin-2 Other descriptive name: PRM-151 | F. Hoffmann-La Roche Ltd | NULL | Not Recruiting | Female: yes Male: yes | 700 | Phase 3 | Portugal;United States;Hong Kong;Taiwan;Greece;Spain;Ukraine;Russian Federation;Israel;Italy;Switzerland;France;Denmark;Peru;Australia;South Africa;Netherlands;China;Korea, Republic of;Czechia;Finland;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Belgium;Brazil;Poland;Singapore;Norway;Germany;New Zealand;Sweden | ||
| 79 | EUCTR2020-000791-38-GR (EUCTR) | 18/02/2021 | 07/12/2020 | A Study to Evaluate the Efficacy and Safety of PRM-151 in Patients with Idiopathic Pulmonary Fibrosis | A PHASE III RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED TRIAL TO EVALUATE THE EFFICACY AND SAFETY OF PRM-151 IN PATIENTS WITH IDIOPATHIC PULMONARY FIBROSIS | Idiopathic pulmonary fibrosis (IPF) MedDRA version: 21.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: Recombinant human Pentraxin-2 (PRM-151) Product Code: RO7490677 160mg/8mL INN or Proposed INN: Recombinant human Pentraxin-2 Other descriptive name: PRM-151 Product Name: Recombinant human Pentraxin-2 (PRM-151) Product Code: RO7490677 320mg/16mL (2nd generation) INN or Proposed INN: Recombinant human Pentraxin-2 Other descriptive name: PRM-151 | F. Hoffmann-La Roche Ltd | NULL | Not Recruiting | Female: yes Male: yes | 658 | Phase 3 | Portugal;United States;Hong Kong;Taiwan;Greece;Spain;Ukraine;Russian Federation;Israel;Italy;Switzerland;France;Denmark;Peru;Australia;South Africa;Netherlands;China;Korea, Republic of;Czechia;Finland;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Belgium;Brazil;Poland;Singapore;Norway;Germany;New Zealand;Sweden | ||
| 80 | EUCTR2020-001429-30-FI (EUCTR) | 16/02/2021 | 04/01/2021 | A Study to Evaluate Long Term Safety and Efficacy of Recombinant Human Pentraxin-2 (rhPTX-2; PRM-151) in Patients with Idiopathic Pulmonary Fibrosis | A PHASE III OPEN-LABEL EXTENSION STUDY TO EVALUATE LONG-TERM SAFETY AND EFFICACY OF PRM-151 IN PATIENTS WITH IDIOPATHIC PULMONARY FIBROSIS (IPF) | Idiopathic pulmonary fibrosis (IPF) MedDRA version: 21.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: Recombinant human Pentraxin-2 (PRM-151) Product Code: RO7490677 160 mg/8 ml INN or Proposed INN: Recombinant human Pentraxin-2 Other descriptive name: PRM-151 Product Name: Recombinant human Pentraxin-2 (PRM-151) Product Code: RO7490677 320 mg/16 ml (2nd generation) INN or Proposed INN: Recombinant human Pentraxin-2 Other descriptive name: PRM-151 | F. Hoffmann-La Roche Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 700 | Phase 3 | Portugal;United States;Hong Kong;Taiwan;Greece;Spain;Ukraine;Russian Federation;Israel;Italy;Switzerland;France;Peru;Australia;Denmark;South Africa;Netherlands;China;Korea, Republic of;Czechia;Finland;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Singapore;Germany;Norway;New Zealand;Sweden | ||
| 81 | EUCTR2019-002709-23-NL (EUCTR) | 16/02/2021 | 06/08/2020 | A study to assess the efficacy, safety and pharmacokinetics of PLN-74809 in participants with idiopathic pulmonary fibrosis | A randomized, double-blind, dose-ranging, placebo-controlled Phase 2a evaluation of the safety, tolerability and pharmacokinetics of PLN-74809 in participants with idiopathic pulmonary fibrosis (IPF) (INTEGRIS-IPF) | Idiopathic pulmonary fibrosis (IPF) MedDRA version: 21.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: PLN-74809 Product Code: PLN-74809 INN or Proposed INN: Not Available Other descriptive name: PLN-74809-020 | Pliant Therapeutics Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 112 | Phase 2 | France;United States;Canada;Belgium;Australia;Germany;Netherlands;United Kingdom;New Zealand;Italy;Korea, Republic of | ||
| 82 | NCT04643769 (ClinicalTrials.gov) | February 9, 2021 | 11/11/2020 | Evaluation of Oral ORIN1001 in Subjects With Idiopathic Pulmonary Fibrosis (IPF) | Phase 1b Double-Blind, Placebo-Controlled, Ascending Dose Trial: ORIN1001 in Subjects With Idiopathic Pulmonary Fibrosis (IPF) | Idiopathic Pulmonary Fibrosis | Drug: ORIN1001;Drug: Placebo | Orinove, Inc. | Vanderbilt University | Active, not recruiting | 40 Years | 80 Years | All | 24 | Phase 1 | United States |
| 83 | EUCTR2020-001429-30-HU (EUCTR) | 05/02/2021 | 09/12/2020 | A Study to Evaluate Long Term Safety and Efficacy of Recombinant Human Pentraxin-2 (rhPTX-2; PRM-151) in Patients with Idiopathic Pulmonary Fibrosis | A PHASE III OPEN-LABEL EXTENSION STUDY TO EVALUATE LONG-TERM SAFETY AND EFFICACY OF PRM-151 IN PATIENTS WITH IDIOPATHIC PULMONARY FIBROSIS (IPF) | Idiopathic pulmonary fibrosis (IPF) MedDRA version: 21.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: Recombinant human Pentraxin-2 (PRM-151) Product Code: RO7490677 INN or Proposed INN: Recombinant human Pentraxin-2 Other descriptive name: PRM-151 | F. Hoffmann-La Roche Ltd | NULL | Not Recruiting | Female: yes Male: yes | 700 | Phase 3 | Portugal;United States;Hong Kong;Taiwan;Greece;Spain;Ukraine;Russian Federation;Israel;Switzerland;Italy;France;Peru;Australia;Denmark;South Africa;Netherlands;China;Korea, Republic of;Czechia;Finland;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Singapore;Norway;Germany;New Zealand;Sweden | ||
| 84 | EUCTR2020-000791-38-HU (EUCTR) | 05/02/2021 | 04/12/2020 | A Study to Evaluate the Efficacy and Safety of PRM-151 in Patients with Idiopathic Pulmonary Fibrosis | A PHASE III RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED TRIAL TO EVALUATE THE EFFICACY AND SAFETY OF PRM-151 IN PATIENTS WITH IDIOPATHIC PULMONARY FIBROSIS | Idiopathic pulmonary fibrosis (IPF) MedDRA version: 21.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: Recombinant human Pentraxin-2 (PRM-151) Product Code: RO7490677 INN or Proposed INN: Recombinant human Pentraxin-2 Other descriptive name: PRM-151 | F. Hoffmann-La Roche Ltd | NULL | Not Recruiting | Female: yes Male: yes | 658 | Phase 3 | France;Peru;Australia;Denmark;South Africa;Netherlands;China;Korea, Republic of;Czechia;Finland;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Singapore;Norway;Germany;New Zealand;Sweden;Switzerland;Italy;Portugal;United States;Hong Kong;Taiwan;Greece;Spain;Ukraine;Russian Federation;Israel | ||
| 85 | EUCTR2020-001429-30-PL (EUCTR) | 28/01/2021 | 19/01/2021 | A Study to Evaluate Long Term Safety and Efficacy of Recombinant Human Pentraxin-2 (rhPTX-2; PRM-151) in Patients with Idiopathic Pulmonary Fibrosis | A PHASE III OPEN-LABEL EXTENSION STUDY TO EVALUATE LONG-TERM SAFETY AND EFFICACY OF PRM-151 IN PATIENTS WITH IDIOPATHIC PULMONARY FIBROSIS (IPF) | Idiopathic pulmonary fibrosis (IPF) MedDRA version: 21.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: Recombinant human Pentraxin-2 (PRM-151) Product Code: RO7490677 INN or Proposed INN: Recombinant human Pentraxin-2 Other descriptive name: PRM-151 Product Name: Recombinant human Pentraxin-2 (PRM-151) Product Code: RO7490677/ F01-02 INN or Proposed INN: Recombinant human Pentraxin-2 Other descriptive name: PRM-151 Product Name: Recombinant human Pentraxin-2 (PRM-151) Product Code: RO7490677/F01-03 INN or Proposed INN: Recombinant human Pentraxin-2 Other descriptive name: PRM-151 | F. Hoffmann-La Roche Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 700 | Phase 3 | Portugal;United States;Hong Kong;Taiwan;Greece;Spain;Ukraine;Russian Federation;Israel;Switzerland;Italy;France;Peru;Australia;Denmark;South Africa;Netherlands;China;Korea, Republic of;Czechia;Finland;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Poland;Belgium;Singapore;Norway;Germany;New Zealand;Sweden | ||
| 86 | JPRN-jRCT2031210008 | 27/01/2021 | 02/04/2021 | A Clinical Study to Test How Effective and Safe GLPG1690 is for Subjects With Idiopathic Pulmonary Fibrosis (IPF) When Used Together With Standard of Care | A Phase 3, Randomized, Double-blind, Parallel-group, Placebo-controlled, Multi-center Study to Evaluate the Efficacy and Safety of Two Doses of GLPG1690 in Addition to Local Standard of Care for Minimum 52 Weeks in Subjects With Idiopathic Pulmonary Fibrosis | Idiopathic Pulmonary Fibrosis | This clinical Phase 3 study is a randomized, double-blind, parallel-group, placebo-controlled multicenter study designed to evaluate the efficacy and safety of two doses (200 mg q.d. and 600 mg q.d.) of orally administered GLPG1690 in addition to local standard of care for at least 52 weeks in adult subjects with a centrally confirmed diagnosis of IPF. Local standard of care for IPF is defined as receiving either pirfenidone or nintedanib at a stable dose for at least two months before screening, and during screening; or neither pirfenidone or nintedanib (for any reason). A stable dose is defined as the highest dose tolerated by the subject during those two months. A total of approximately 750 subjects with confirmed diagnosis of IPF will be randomized, 250 subjects in each treatment group (GLPG1690 600 mg q.d., GLPG1690200 mg q.d., or matching placebo). | Kayamori Takefumi | NULL | Not Recruiting | >= 40age old | Not applicable | Both | 49 | Phase 3 | Japan;USA;Denmark;Peru;Australia;Germany;Taiwan;Belgium;Greece;Brazil;Spain;Chile;United Kingdom;Czech Republic;Turkey |
| 87 | EUCTR2020-000791-38-PL (EUCTR) | 22/01/2021 | 19/01/2021 | A Study to Evaluate the Efficacy and Safety of PRM-151 in Patients with Idiopathic Pulmonary Fibrosis | A PHASE III RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED TRIAL TO EVALUATE THE EFFICACY AND SAFETY OF PRM-151 IN PATIENTS WITH IDIOPATHIC PULMONARY FIBROSIS | Idiopathic pulmonary fibrosis (IPF) MedDRA version: 21.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: Recombinant human Pentraxin-2 (PRM-151) Product Code: RO7490677 INN or Proposed INN: Recombinant human Pentraxin-2 Other descriptive name: PRM-151 | F. Hoffmann-La Roche Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 658 | Phase 3 | Portugal;United States;Hong Kong;Taiwan;Greece;Spain;Ukraine;Russian Federation;Israel;Switzerland;Italy;France;Peru;Australia;Denmark;South Africa;Netherlands;China;Korea, Republic of;Czechia;Finland;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Poland;Belgium;Singapore;Norway;Germany;New Zealand;Sweden | ||
| 88 | EUCTR2020-001429-30-CZ (EUCTR) | 20/01/2021 | 02/12/2020 | A Study to Evaluate Long Term Safety and Efficacy of Recombinant Human Pentraxin-2 (rhPTX-2; PRM-151) in Patients with Idiopathic Pulmonary Fibrosis | A PHASE III OPEN-LABEL EXTENSION STUDY TO EVALUATE LONG-TERM SAFETY AND EFFICACY OF PRM-151 IN PATIENTS WITH IDIOPATHIC PULMONARY FIBROSIS (IPF) | Idiopathic pulmonary fibrosis (IPF) MedDRA version: 21.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: Recombinant human Pentraxin-2 (PRM-151) Product Code: RO7490677 INN or Proposed INN: Recombinant human Pentraxin-2 Other descriptive name: PRM-151 | F. Hoffmann-La Roche Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 700 | Phase 3 | United States;Portugal;Taiwan;Hong Kong;Greece;Spain;Ukraine;Russian Federation;Israel;Switzerland;Italy;France;Denmark;Australia;Peru;South Africa;Netherlands;China;Korea, Republic of;Czechia;Finland;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Singapore;Germany;Norway;New Zealand;Sweden | ||
| 89 | EUCTR2020-000791-38-CZ (EUCTR) | 20/01/2021 | 30/11/2020 | A Study to Evaluate the Efficacy and Safety of PRM-151 in Patients with Idiopathic Pulmonary Fibrosis | A PHASE III RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED TRIAL TO EVALUATE THE EFFICACY AND SAFETY OF PRM-151 IN PATIENTS WITH IDIOPATHIC PULMONARY FIBROSIS | Idiopathic pulmonary fibrosis (IPF) MedDRA version: 21.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: Recombinant human Pentraxin-2 (PRM-151) Product Code: RO7490677 INN or Proposed INN: Recombinant human Pentraxin-2 Other descriptive name: PRM-151 | F. Hoffmann-La Roche Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 658 | Phase 3 | United States;Portugal;Taiwan;Hong Kong;Greece;Spain;Ukraine;Russian Federation;Israel;Switzerland;Italy;France;Denmark;Australia;Peru;South Africa;Netherlands;China;Korea, Republic of;Czechia;Finland;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Singapore;Germany;Norway;New Zealand;Sweden | ||
| 90 | JPRN-jRCTs051200109 | 18/01/2021 | 15/01/2021 | DREAM study | A multicenter, open-label, prospective study of durvalumab, etoposide, and carboplatin for unresectable small cell lung cancer with mild idiopathic interstitial pneumonia - DREAM study | Small cell lung cancer | Patients will receive etoposide (<75 years old: 100mg/m2; >=75 years old: 80mg/m2; intravenously on day 1-3), carboplatin (area under the curve 5 mg/mL intravenously on day 1), and durvalumab (1500mg/body intravenously on day1) every three weeks for four cycles. Thereafter, patients will continue to receive durvalumab monotherapy (1500mg/body intravenously on day 1 every three weeks), until relapse, or unacceptable toxicity. | Fujimoto Daichi | NULL | Recruiting | >= 20age old | Not applicable | Both | 22 | N/A | Japan |
| 91 | NCT04525547 (ClinicalTrials.gov) | January 13, 2021 | 21/8/2020 | Safety and Effectiveness of Nintedanib in Korean Patients | A Regulatory Required Non-interventional Study to Monitor the Safety and Effectiveness of Ofev(Nintedanib 150mg/100mg BID) in Korean Patients | Idiopathic Pulmonary Fibrosis | Drug: Nintedanib | Boehringer Ingelheim | NULL | Completed | N/A | N/A | All | 70 | Korea, Republic of | |
| 92 | EUCTR2019-002709-23-IT (EUCTR) | 29/12/2020 | 24/05/2021 | A study to assess the efficacy, safety and pharmacokinetics of PLN-74809 in participants with idiopathic pulmonary fibrosis | A randomized, double-blind, dose-ranging, placebo-controlled Phase 2a evaluation of the safety, tolerability and pharmacokinetics of PLN 74809 in participants with idiopathic pulmonary fibrosis (IPF) (INTEGRIS-IPF) - INTEGRIS-IPF | idiopathic pulmonary fibrosis MedDRA version: 20.0;Level: SOC;Classification code 10038738;Term: Respiratory, thoracic and mediastinal disorders;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: PLN-74809 Product Code: [PLN-74809] Other descriptive name: PLN-74809-000 | Pliant Therapeutics Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 84 | Phase 2 | France;United States;Canada;Belgium;Australia;Netherlands;Germany;United Kingdom;New Zealand;Italy | ||
| 93 | NCT04614441 (ClinicalTrials.gov) | December 25, 2020 | 29/10/2020 | NICEFIT-ON: A Study Under Routine Clinical Practice in Taiwan to Observe the Long-term Outcome of People With Certain Types of Lung Disease (PF-ILD, SSc-ILD, IPF) Who Start Treatment With Nintedanib | Non-Interventional Collecting Evidences For ILD in Taiwan: Optimized Novel Therapy | Idiopathic Pulmonary Fibrosis | Drug: OFEV® | Boehringer Ingelheim | NULL | Active, not recruiting | 20 Years | N/A | All | 214 | Taiwan | |
| 94 | EUCTR2020-000697-22-NL (EUCTR) | 24/12/2020 | 04/06/2020 | A study to compare the use of Pamrevlumab with Placebo in patients with Idiopathic Pulmonary Fibrosis. | Zephyrus II: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Efficacy and Safety Study of Pamrevlumab in Subjects with Idiopathic Pulmonary Fibrosis (IPF). | Idiopathic Pulmonary Fibrosis MedDRA version: 21.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17] | Product Name: Pamrevlumab Product Code: FG-3019 INN or Proposed INN: PAMREVLUMAB | FibroGen, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 340 | Phase 3 | Serbia;Czechia;Spain;Ukraine;Ireland;Lebanon;Colombia;United Kingdom;Switzerland;Italy;France;Hungary;Mexico;Poland;Brazil;Dominican Republic;Peru;Denmark;Georgia;Netherlands;Germany | ||
| 95 | EUCTR2020-000791-38-IT (EUCTR) | 21/12/2020 | 15/06/2021 | A Study to Evaluate the Efficacy and Safety of PRM-151 in Patients with Idiopathic Pulmonary Fibrosis | A PHASE III RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED TRIAL TO EVALUATE THE EFFICACY AND SAFETY OF PRM-151 IN PATIENTS WITH IDIOPATHIC PULMONARY FIBROSIS - - | Idiopathic pulmonary fibrosis (IPF) MedDRA version: 21.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: Recombinant human Pentraxin-2 (PRM-151) Product Code: [RO7490677] INN or Proposed INN: Recombinant human Pentraxin-2 Other descriptive name: PRM-151 | F. HOFFMANN - LA ROCHE LTD. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 658 | Phase 3 | Portugal;United States;Hong Kong;Taiwan;Greece;Spain;Ukraine;Russian Federation;Israel;Switzerland;Italy;France;Peru;Australia;Denmark;South Africa;Netherlands;China;Korea, Republic of;Czechia;Finland;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Singapore;Norway;Germany;New Zealand;Sweden | ||
| 96 | EUCTR2020-001429-30-IT (EUCTR) | 21/12/2020 | 14/06/2021 | A Study to Evaluate Long Term Safety and Efficacy of Recombinant Human Pentraxin-2 (rhPTX-2; PRM-151) in Patients with Idiopathic Pulmonary Fibrosis | A PHASE III OPEN-LABEL EXTENSION STUDY TO EVALUATE LONG-TERM SAFETY AND EFFICACY OF PRM-151 IN PATIENTS WITH IDIOPATHIC PULMONARY FIBROSIS (IPF) - - | Idiopathic pulmonary fibrosis (IPF) MedDRA version: 21.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: Recombinant human Pentraxin-2 (PRM-151) Product Code: [RO7490677] INN or Proposed INN: Recombinant human Pentraxin-2 Other descriptive name: PRM-151 | F. HOFFMANN - LA ROCHE LTD. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 700 | Phase 3 | Portugal;United States;Hong Kong;Taiwan;Greece;Spain;Ukraine;Russian Federation;Israel;Switzerland;Italy;France;Peru;Australia;Denmark;South Africa;Netherlands;China;Korea, Republic of;Czechia;Finland;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Singapore;Norway;Germany;New Zealand;Sweden | ||
| 97 | EUCTR2019-002709-23-DE (EUCTR) | 18/12/2020 | 31/01/2020 | A study to assess the efficacy, safety and pharmacokinetics of PLN-74809 in participants with idiopathic pulmonary fibrosis | A randomized, double-blind, dose-ranging, placebo-controlled Phase 2a evaluation of the safety, tolerability and pharmacokinetics of PLN-74809 inparticipants with idiopathic pulmonary fibrosis (IPF) (INTEGRIS-IPF) | Idiopathic pulmonary fibrosis (IPF) MedDRA version: 21.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: PLN-74809 Product Code: PLN-74809 INN or Proposed INN: Not Available Other descriptive name: PLN-74809-020 | Pliant Therapeutics Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 112 | Phase 2 | United States;France;Canada;Belgium;Australia;Netherlands;Germany;United Kingdom;New Zealand;Italy;Korea, Republic of | ||
| 98 | NCT04300920 (ClinicalTrials.gov) | December 17, 2020 | 6/3/2020 | Prospective Treatment Efficacy in IPF Using Genotype for Nac Selection (PRECISIONS) Trial | Prospective Treatment Efficacy in IPF Using Genotype for Nac Selection (PRECISIONS) Trial | Idiopathic Pulmonary Fibrosis | Drug: N-acetyl cysteine;Drug: Placebo | Weill Medical College of Cornell University | University of Virginia;University of Michigan;Pulmonary Fibrosis Foundation;University of Washington;National Heart, Lung, and Blood Institute (NHLBI);Three Lakes Foundation | Recruiting | 40 Years | N/A | All | 200 | Phase 3 | United States |
| 99 | EUCTR2019-004167-45-GR (EUCTR) | 17/12/2020 | 03/12/2020 | A study to test how taking BI 1015550 for 12 weeks affects lungfunction in people with idiopathic pulmonary fibrosis (IPF). | A randomised, double-blind, placebo-controlled parallel groupstudy in IPF patients over 12 weeks evaluating efficacy, safety andtolerability of BI 1015550 taken orally. | Idiopathic Pulmonary Fibrosis MedDRA version: 21.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Code: BI 1015550 INN or Proposed INN: BI 1015550 Other descriptive name: BI 1015550 Product Code: BI 1015550 INN or Proposed INN: BI 1015550 Other descriptive name: BI 1015550 | NULL | Not Recruiting | Female: yes Male: yes | 150 | Phase 2 | United States;Slovakia;Greece;Spain;Ukraine;Chile;Russian Federation;Italy;Denmark;Australia;Netherlands;China;Korea, Republic of;Czechia;Finland;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Germany;Japan | |||
| 100 | NCT04429516 (ClinicalTrials.gov) | December 17, 2020 | 12/3/2020 | Morphine Sulfate/Placebo for the Treatment of PulmonAry Fibrosis Cough | PAciFy Cough: A Multicentre, Double Blind, Placebo Controlled, Crossover Trial of Morphine Sulfate for the Treatment of PulmonAry Fibrosis Cough | Idiopathic Pulmonary Fibrosis | Drug: Morphine Sulfate;Drug: Placebo oral tablet | Royal Brompton & Harefield NHS Foundation Trust | NULL | Recruiting | 40 Years | 90 Years | All | 44 | Phase 3 | United Kingdom |
| 101 | EUCTR2019-003992-21-IT (EUCTR) | 15/12/2020 | 30/08/2021 | A Study Measuring the Effectiveness, Safety, and Tolerability of BMS-986278 in Participants with Lung Fibrosis | A Multicenter, Randomized, Double-blind, Placebo-controlled, Phase 2 Study of the Efficacy and the Safety and Tolerability of BMS-986278 in Participants with Pulmonary Fibrosis - Phase 2 Study of the Efficacy and Safety of BMS-986278 in Pulmonary Fibrosis | Pulmonary Fibrosis MedDRA version: 21.0;Level: PT;Classification code 10037383;Term: Pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders MedDRA version: 21.1;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: BMS-986278 Product Code: [BMS-986278] INN or Proposed INN: LPA1 Other descriptive name: BMS-986278 Product Name: BMS-986278 Product Code: [BMS-986278] INN or Proposed INN: LPA1 Other descriptive name: BMS-986278 | BRISTOL-MYERS SQUIBB INTERNATIONAL CORPORATION | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 360 | Phase 2 | United States;Taiwan;Spain;Chile;Israel;United Kingdom;Italy;France;Mexico;Canada;Argentina;Brazil;Belgium;Australia;Germany;Japan;Korea, Republic of | ||
| 102 | EUCTR2019-002709-23-GB (EUCTR) | 06/11/2020 | 24/01/2020 | A study to assess the efficacy, safety and pharmacokinetics of PLN-74809 in participants with idiopathic pulmonary fibrosis | A randomized, double-blind, dose-ranging, placebo-controlled Phase 2a evaluation of the safety, tolerability and pharmacokinetics of PLN-74809 in participants with idiopathic pulmonary fibrosis (IPF) (INTEGRIS-IPF) | Idiopathic pulmonary fibrosis (IPF) MedDRA version: 21.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: PLN-74809 Product Code: PLN-74809 INN or Proposed INN: Not Available Other descriptive name: PLN-74809-000 Product Name: PLN-74809 Product Code: PLN-74809 INN or Proposed INN: Not available Other descriptive name: PLN-74809-000 Product Name: PLN-74809 Product Code: PLN-74809 INN or Proposed INN: Not Available Other descriptive name: PLN-74809-000 | Pliant Therapeutics Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 40 | Phase 2 | United States;France;Canada;Belgium;Australia;Netherlands;Germany;New Zealand;Italy;United Kingdom | ||
| 103 | EUCTR2019-004167-45-SK (EUCTR) | 02/11/2020 | 11/08/2020 | A study to test how taking BI 1015550 for 12 weeks affects lungfunction in people with idiopathic pulmonary fibrosis (IPF). | A randomised, double-blind, placebo-controlled parallel groupstudy in IPF patients over 12 weeks evaluating efficacy, safety andtolerability of BI 1015550 taken orally. | Idiopathic Pulmonary Fibrosis MedDRA version: 21.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Code: BI 1015550 INN or Proposed INN: BI 1015550 Other descriptive name: BI 1015550 Product Code: BI 1015550 INN or Proposed INN: BI 1015550 Other descriptive name: BI 1015550 | Boehringer Ingelheim RCV GmbH & Co KG | NULL | Not Recruiting | Female: yes Male: yes | 150 | Phase 2 | United States;Slovakia;Greece;Spain;Ukraine;Russian Federation;Chile;Italy;Denmark;Australia;Netherlands;China;Korea, Republic of;Czechia;Finland;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Germany;Japan | ||
| 104 | EUCTR2019-004167-45-AT (EUCTR) | 23/10/2020 | 06/07/2020 | A randomised, double-blind, placebo-controlled parallel group study in IPF patients over 12 weeks evaluating efficacy, safety and tolerability of BI 1015550 taken orally. | A randomised, double-blind, placebo-controlled parallel group study in IPF patients over 12 weeks evaluating efficacy, safety and tolerability of BI 1015550 taken orally. | Idiopathic Pulmonary Fibrosis MedDRA version: 21.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Code: BI 1015550 INN or Proposed INN: BI 1015550 Other descriptive name: BI 1015550 Product Code: BI 1015550 INN or Proposed INN: BI 1015550 Other descriptive name: BI 1015550 | Boehringer Ingelheim RCV GmbH & Co KG | NULL | Not Recruiting | Female: yes Male: yes | 150 | Phase 2 | United States;Slovakia;Greece;Spain;Ukraine;Russian Federation;Chile;Italy;France;Denmark;Australia;Netherlands;China;Korea, Republic of;Czechia;Finland;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Germany;Japan | ||
| 105 | NCT04589260 (ClinicalTrials.gov) | October 15, 2020 | 8/10/2020 | TD-1058 First-In-Human Study in Healthy Subjects and Subjects With Idiopathic Pulmonary Fibrosis | A Ph 1, Rndmzd, Dbl-Blinded, Pbo-Controlled, 3-Part Study to Eval the Safety, Tolerability, PK, and PD of TD-1058 Admin by Inhalation of Single (A) and Multiple (B) Ascending Doses in Healthy Subjs and Subjs With IPF (C) | Idiopathic Pulmonary Fibrosis (IPF) | Drug: TD-1058;Drug: Placebo | Theravance Biopharma | NULL | Recruiting | 18 Years | N/A | All | 96 | Phase 1 | United Kingdom |
| 106 | EUCTR2020-000697-22-DK (EUCTR) | 13/10/2020 | 14/08/2020 | A study to compare the use of Pamrevlumab with Placebo in patients with Idiopathic Pulmonary Fibrosis. | Zephyrus II: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Efficacy and Safety Study of Pamrevlumab in Subjects with Idiopathic Pulmonary Fibrosis (IPF). | Idiopathic Pulmonary Fibrosis MedDRA version: 21.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17] | Product Name: Pamrevlumab Product Code: FG-3019 INN or Proposed INN: PAMREVLUMAB | FibroGen, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 340 | Phase 3 | Serbia;Czechia;Spain;Ukraine;Ireland;Lebanon;Colombia;United Kingdom;Switzerland;Italy;France;Hungary;Mexico;Poland;Brazil;Dominican Republic;Denmark;Peru;Georgia;Netherlands;Germany | ||
| 107 | EUCTR2020-000697-22-DE (EUCTR) | 13/10/2020 | 05/08/2020 | A study to compare the use of Pamrevlumab with Placebo in patients with Idiopathic Pulmonary Fibrosis. | Zephyrus II: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Efficacy and Safety Study of Pamrevlumab in Subjects with Idiopathic Pulmonary Fibrosis (IPF). | Idiopathic Pulmonary Fibrosis MedDRA version: 21.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17] | Product Name: Pamrevlumab Product Code: FG-3019 INN or Proposed INN: PAMREVLUMAB | FibroGen, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 340 | Phase 3 | Serbia;Czechia;Spain;Ukraine;Ireland;Lebanon;Colombia;United Kingdom;Switzerland;Italy;France;Hungary;Mexico;Poland;Brazil;Dominican Republic;Peru;Denmark;Georgia;Netherlands;Germany | ||
| 108 | NCT04419558 (ClinicalTrials.gov) | September 30, 2020 | 3/6/2020 | Zephyrus II: Efficacy and Safety Study of Pamrevlumab in Participants With Idiopathic Pulmonary Fibrosis (IPF) | Zephyrus II: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Efficacy and Safety Study of Pamrevlumab in Subjects With Idiopathic Pulmonary Fibrosis (IPF) | Idiopathic Pulmonary Fibrosis | Drug: Pamrevlumab;Drug: Placebo | FibroGen | NULL | Recruiting | 40 Years | 85 Years | All | 340 | Phase 3 | United States;Argentina;Brazil;China;Colombia;Czechia;Denmark;Dominican Republic;France;Georgia;Germany;Hungary;Ireland;Italy;Korea, Republic of;Lebanon;Mexico;Netherlands;Peru;Poland;Serbia;Spain;Switzerland;Ukraine;United Kingdom |
| 109 | NCT04312594 (ClinicalTrials.gov) | September 8, 2020 | 27/2/2020 | Jaktinib Dihydrochloride Monohydrate in Idiopathic Pulmonary Fibrosis | A Multicenter, Randomized, Double-Blind,Placebo-controlled,Phase 2 Trial of Jaktinib Dihydrochloride Monohydrate in Idiopathic Pulmonary Fibrosis | Idiopathic Pulmonary Fibrosis | Drug: Jaktinib Dihydrochloride Monohydrate 50mg BID and Mimic tablets of jakitinib hydrochloride 75mg BID and Acetylcysteine Effervescent Tablets;Drug: Jaktinib Dihydrochloride Monohydrate 75mg BID and Mimic tablets of jakitinib hydrochloride 50mg BID and Acetylcysteine Effervescent Tablets;Drug: Placebo oral tablet and Acetylcysteine Effervescent Tablets | Suzhou Zelgen Biopharmaceuticals Co.,Ltd | NULL | Recruiting | 50 Years | N/A | All | 90 | Phase 2 | China |
| 110 | NCT03865927 (ClinicalTrials.gov) | September 7, 2020 | 1/3/2019 | GKT137831 in IPF Patients With Idiopathic Pulmonary Fibrosis | A Randomized, Double-Blind, Placebo-Controlled Phase II Clinical Trial of GKT137831 in Patients With Idiopathic Pulmonary Fibrosis | Idiopathic Pulmonary Fibrosis | Other: Placebo Oral Tablet;Drug: GKT137831 | University of Alabama at Birmingham | NULL | Recruiting | 40 Years | 85 Years | All | 60 | Phase 2 | United States |
| 111 | NCT04534478 (ClinicalTrials.gov) | September 7, 2020 | 31/8/2020 | Oral Prednisone Regimens to Optimize the Therapeutic Strategy in Patients With Organizing Pneumonia Post-COVID-19 | Randomized, Open, Parallel, Single-center, Non-inferiority Clinical Trial, With an Active Control Group, Comparing Two Oral Prednisone Regimens With the Aim of Optimizing the Therapeutic Strategy in Patients With Organizing Pneumonia Post-COVID-19 Infection | COVID-19 Pneumonia | Drug: Prednisone | Hospital Universitari Vall d'Hebron Research Institute | NULL | Not yet recruiting | 18 Years | N/A | All | 120 | Phase 4 | NULL |
| 112 | EUCTR2019-004167-45-DK (EUCTR) | 27/08/2020 | 12/06/2020 | A study to test how taking BI 1015550 for 12 weeks affects lungfunction in people with idiopathic pulmonary fibrosis (IPF). | A randomised, double-blind, placebo-controlled parallel groupstudy in IPF patients over 12 weeks evaluating efficacy, safety andtolerability of BI 1015550 taken orally. | Idiopathic Pulmonary Fibrosis MedDRA version: 21.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Code: BI 1015550 INN or Proposed INN: BI 1015550 Other descriptive name: BI 1015550 Product Code: BI 1015550 INN or Proposed INN: BI 1015550 Other descriptive name: BI 1015550 | Boehringer Ingelheim B.V. | NULL | Not Recruiting | Female: yes Male: yes | 150 | Phase 2 | United States;Slovakia;Greece;Spain;Ukraine;Russian Federation;Chile;Italy;France;Australia;Denmark;Netherlands;China;Korea, Republic of;Czechia;Finland;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Germany;Japan | ||
| 113 | EUCTR2019-004167-45-PL (EUCTR) | 24/08/2020 | 14/07/2020 | A study to test how taking BI 1015550 for 12 weeks affects lungfunction in people with idiopathic pulmonary fibrosis (IPF). | A randomised, double-blind, placebo-controlled parallel groupstudy in IPF patients over 12 weeks evaluating efficacy, safety andtolerability of BI 1015550 taken orally. | Idiopathic Pulmonary Fibrosis MedDRA version: 21.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Code: BI 1015550 INN or Proposed INN: BI 1015550 Other descriptive name: BI 1015550 Product Code: BI 1015550 INN or Proposed INN: BI 1015550 Other descriptive name: BI 1015550 | Boehringer Ingelheim RCV GmbH & Co KG | NULL | Not Recruiting | Female: yes Male: yes | 150 | Phase 2 | United States;Slovakia;Greece;Spain;Ukraine;Chile;Russian Federation;Italy;France;Denmark;Australia;Netherlands;China;Korea, Republic of;Czechia;Finland;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Germany;Japan | ||
| 114 | EUCTR2019-004167-45-GB (EUCTR) | 19/08/2020 | 24/06/2020 | A study to test how taking BI 1015550 for 12 weeks affects lung function in people with idiopathic pulmonary fibrosis (IPF). | A randomised, double-blind, placebo-controlled parallel group study in IPF patients over 12 weeks evaluating efficacy, safety and tolerability of BI 1015550 taken orally. | Idiopathic Pulmonary Fibrosis MedDRA version: 21.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Code: BI 1015550 INN or Proposed INN: BI 1015550 Other descriptive name: BI 1015550 Product Code: BI 1015550 INN or Proposed INN: BI 1015550 Other descriptive name: BI 1015550 | Boehringer Ingelheim Limited | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 150 | Phase 2 | United States;Slovakia;Greece;Finland;Spain;Ukraine;Austria;Russian Federation;Chile;Italy;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Australia;Denmark;Netherlands;Germany;Japan;China;Korea, Republic of | ||
| 115 | EUCTR2019-004167-45-HU (EUCTR) | 17/08/2020 | 24/06/2020 | A study to test how taking BI 1015550 for 12 weeks affects lung function in people with idiopathic pulmonary fibrosis (IPF). | A randomised, double-blind, placebo-controlled parallel group study in IPF patients over 12 weeks evaluating efficacy, safety and tolerability of BI 1015550 18 mg taken orally b.i.d. | Idiopathic Pulmonary Fibrosis MedDRA version: 21.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Code: BI 1015550 INN or Proposed INN: BI 1015550 Other descriptive name: BI 1015550 Product Code: BI 1015550 INN or Proposed INN: BI 1015550 Other descriptive name: BI 1015550 | Boehringer Ingelheim RCV GmbH & Co KG | NULL | Not Recruiting | Female: yes Male: yes | 150 | Phase 2 | United States;Slovakia;Greece;Spain;Russian Federation;Chile;Italy;France;Australia;Denmark;Netherlands;China;Korea, Republic of;Czechia;Finland;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Germany;Japan | ||
| 116 | EUCTR2019-003992-21-DE (EUCTR) | 06/08/2020 | 27/05/2020 | A Study Measuring the Effectiveness, Safety, and Tolerability of BMS-986278 in Participants with Lung Fibrosis | A Multicenter, Randomized, Double-blind, Placebo-controlled, Phase 2 Study of the Efficacy and the Safety and Tolerability of BMS-986278 in Participants with Pulmonary Fibrosis - Phase 2 Study of the Efficacy and Safety of BMS-986278 in Pulmonary Fibrosis | Pulmonary Fibrosis MedDRA version: 21.0;Level: PT;Classification code 10037383;Term: Pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders MedDRA version: 21.1;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: BMS-986278 Product Code: BMS-986278 INN or Proposed INN: LPA1 Other descriptive name: BMS-986278 Product Name: BMS-986278 Product Code: BMS-986278 INN or Proposed INN: LPA1 Other descriptive name: BMS-986278 | Bristol-Myers Squibb International Corporation | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 360 | Phase 2 | United States;Taiwan;Spain;Chile;Israel;United Kingdom;Italy;France;Mexico;Canada;Argentina;Brazil;Belgium;Australia;Germany;Japan;Korea, Republic of | ||
| 117 | NCT04071769 (ClinicalTrials.gov) | August 3, 2020 | 9/8/2019 | Genentech Xenon MRI Idiopathic Pulmonary Fibrosis | Using Xenon MRI to Evaluate the Efficacy of Therapies for Idiopathic Pulmonary Fibrosis | Idiopathic Pulmonary Fibrosis | Drug: Hyperpolarized 129 Xenon Gas Comparing Idiopathic Pulmonary Fibrosis (IPF) Treatment | Duke University | NULL | Recruiting | 18 Years | N/A | All | 20 | Phase 2 | United States |
| 118 | EUCTR2019-004167-45-DE (EUCTR) | 30/07/2020 | 22/06/2020 | A study to test how taking BI 1015550 for 12 weeks affects lungfunction in people with idiopathic pulmonary fibrosis (IPF). | A randomised, double-blind, placebo-controlled parallel groupstudy in IPF patients over 12 weeks evaluating efficacy, safety andtolerability of BI 1015550 taken orally. | Idiopathic Pulmonary Fibrosis MedDRA version: 21.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Code: BI 1015550 INN or Proposed INN: BI 1015550 Other descriptive name: BI 1015550 Product Code: BI 1015550 INN or Proposed INN: BI 1015550 Other descriptive name: BI 1015550 | Boehringer Ingelheim Pharma GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 150 | Phase 2 | United States;Slovakia;Greece;Spain;Ukraine;Russian Federation;Chile;Italy;Denmark;Australia;Netherlands;China;Korea, Republic of;Czechia;Finland;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Germany;Japan | ||
| 119 | EUCTR2020-000697-22-IT (EUCTR) | 29/07/2020 | 21/01/2021 | A study to compare the use of Pamrevlumab with Placebo in patients with Idiopathic Pulmonary Fibrosis. | Zephyrus II: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Efficacy and Safety Study of Pamrevlumab in Subjects with Idiopathic Pulmonary Fibrosis (IPF). - Zephyrus II | Idiopathic Pulmonary Fibrosis MedDRA version: 21.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17] | Product Name: Pamrevlumab Product Code: [FG-3019] INN or Proposed INN: PAMREVLUMAB | FIBROGEN | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 340 | Phase 3 | Serbia;Czechia;Spain;Ukraine;Ireland;Lebanon;Colombia;United Kingdom;Italy;India;France;Hungary;Mexico;Poland;Brazil;Belgium;Dominican Republic;Denmark;Peru;Georgia;Bulgaria;Norway;Netherlands;Germany | ||
| 120 | NCT04419506 (ClinicalTrials.gov) | July 28, 2020 | 4/6/2020 | A Study to Test How Taking BI 1015550 for 12 Weeks Affects Lung Function in People With Idiopathic Pulmonary Fibrosis (IPF) | A Randomised, Double-blind, Placebo-controlled Parallel Group Study in IPF Patients Over 12 Weeks Evaluating Efficacy, Safety and Tolerability of BI 1015550 Taken Orally | Idiopathic Pulmonary Fibrosis | Drug: BI 1015550;Drug: Placebo | Boehringer Ingelheim | NULL | Completed | 40 Years | N/A | All | 147 | Phase 2 | United States;Argentina;Australia;Austria;Canada;Chile;China;Czechia;Denmark;Finland;Germany;Greece;Hungary;Italy;Japan;Korea, Republic of;Netherlands;Poland;Russian Federation;Spain;Ukraine;United Kingdom |
| 121 | EUCTR2019-004998-34-GB (EUCTR) | 16/07/2020 | 04/02/2020 | A clinical study to investigate the safety and effects of a new drug called BLD-2660 in patients with Idiopathic Pulmonary Fibrosis | A Phase 2a, Double-Blind, Placebo-Controlled Study to Evaluate Pharmacodynamics, Pharmacokinetics, and Safety of BLD-2660 Administered Orally in Subjects with Idiopathic Pulmonary Fibrosis - B-2660-203 | Idiopathic Pulmonary Fibrosis MedDRA version: 21.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: BLD-2660 Product Code: BLD-2660 INN or Proposed INN: None Other descriptive name: BLD-2660 | Blade Therapeutics, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 40 | Phase 2 | United Kingdom | ||
| 122 | NCT04512170 (ClinicalTrials.gov) | July 13, 2020 | 7/8/2020 | Single and Multiple Dose Safety, Tolerability, PK and Food Effect Study of HEC585 in Healthy Male and Female Subjects | A Randomized, Double-Blind, Placebo-Controlled Study of Ascending Single and Multiple Doses to Evaluate the Safety, Tolerability, Pharmacokinetics, and Randomized, Open-label,Crossover, Food Effect Study of HEC585 in Healthy Chinese Subjects | Idiopathic Pulmonary Fibrosis | Drug: HEC585;Drug: placebo | Sunshine Lake Pharma Co., Ltd. | NULL | Completed | 18 Years | 45 Years | All | 72 | Phase 1 | China |
| 123 | EUCTR2019-004167-45-NL (EUCTR) | 09/07/2020 | 12/05/2020 | A study to test how taking BI 1015550 for 12 weeks affects lungfunction in people with idiopathic pulmonary fibrosis (IPF). | A randomised, double-blind, placebo-controlled parallel groupstudy in IPF patients over 12 weeks evaluating efficacy, safety andtolerability of BI 1015550 taken orally. | Idiopathic Pulmonary Fibrosis MedDRA version: 21.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Code: BI 1015550 INN or Proposed INN: BI 1015550 Other descriptive name: BI 1015550 Product Code: BI 1015550 INN or Proposed INN: BI 1015550 Other descriptive name: BI 1015550 | Boehringer Ingelheim | NULL | Not Recruiting | Female: yes Male: yes | 150 | Phase 2 | United States;Slovakia;Greece;Spain;Ukraine;Russian Federation;Chile;Italy;Australia;Denmark;Netherlands;China;Korea, Republic of;Czechia;Finland;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Germany;Japan | ||
| 124 | EUCTR2019-004167-45-IT (EUCTR) | 09/07/2020 | 17/06/2021 | A study to test how taking BI 1015550 for 12 weeks affects lung function in people with idiopathic pulmonary fibrosis (IPF). | A randomised, double-blind, placebo-controlled parallel group study in IPF patients over 12 weeks evaluating efficacy, safety and tolerability of BI 1015550 taken orally. - - | Idiopathic Pulmonary Fibrosis MedDRA version: 21.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: - Product Code: [BI 1015550] Other descriptive name: BI 1015550 Product Name: - Product Code: [BI 1015550] Other descriptive name: BI 1015550 | BOEHRINGER-INGELHEIM ITALIA S.P.A. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 150 | Phase 2 | United States;Czechia;Slovakia;Greece;Finland;Spain;Ukraine;Austria;Russian Federation;United Kingdom;Italy;France;Hungary;Czech Republic;Mexico;Canada;Poland;Australia;Denmark;Netherlands;Germany;China;Japan;Korea, Republic of | ||
| 125 | EUCTR2020-000697-22-HU (EUCTR) | 08/07/2020 | 22/05/2020 | A study to compare the use of Pamrevlumab with Placebo in patients with Idiopathic Pulmonary Fibrosis. | Zephyrus II: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Efficacy and Safety Study of Pamrevlumab in Subjects with Idiopathic Pulmonary Fibrosis (IPF). | Idiopathic Pulmonary Fibrosis MedDRA version: 21.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17] | Product Name: Pamrevlumab Product Code: FG-3019 INN or Proposed INN: PAMREVLUMAB | FibroGen, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 340 | Phase 3 | Serbia;Spain;Ukraine;Lebanon;Ireland;Colombia;Italy;United Kingdom;India;France;Hungary;Czech Republic;Mexico;Poland;Belgium;Brazil;Dominican Republic;Peru;Denmark;Bulgaria;Georgia;Norway;Netherlands;Germany | ||
| 126 | EUCTR2020-000822-24-GB (EUCTR) | 06/07/2020 | 03/04/2020 | To investigate the safety, effectiveness and fate of study drug C21 in people with chronic scarring lung disease characterised by a progressive and irreversible decline in lung function. | A Phase 2, Multi-Centre, Open-Label, Single-Arm Trial Investigating the Safety, Efficacy and Pharmacokinetics of C21 in Subjects with Idiopathic Pulmonary Fibrosis - C21 in IPF | Idiopathic Pulmonary Fibrosis MedDRA version: 21.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: C21 INN or Proposed INN: C21 Other descriptive name: 3-[4-(1H-imidazol-1-ylmethyl)phenyl]-5-(2-methylpropyl)thiophene-2-[(N-butyloxylcarbamate)-sulphonamide] sodium salt | Vicore Pharma AB | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 60 | Phase 2 | Ukraine;United Kingdom | ||
| 127 | EUCTR2019-003992-21-BE (EUCTR) | 03/07/2020 | 04/05/2020 | A Multicenter, Randomized, Double-blind, Placebo-controlled, Phase 2 Study of the Efficacy and the Safety and Tolerability of BMS-986278 in Participants with Pulmonary Fibrosis | A Multicenter, Randomized, Double-blind, Placebo-controlled, Phase 2 Study of the Efficacy and the Safety and Tolerability of BMS-986278 in Participants with Pulmonary Fibrosis - Phase 2 Study of the Efficacy and Safety of BMS-986278 in Pulmonary Fibrosis | Pulmonary Fibrosis MedDRA version: 21.0;Level: PT;Classification code 10037383;Term: Pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders MedDRA version: 21.1;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: BMS-986278 Product Code: BMS-986278 INN or Proposed INN: LPA1 Other descriptive name: BMS-986278 Product Name: BMS-986278 Product Code: BMS-986278 INN or Proposed INN: LPA1 Other descriptive name: BMS-986278 | Bristol-Myers Squibb International Corporation | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 360 | Phase 2 | United States;Spain;Chile;Israel;United Kingdom;Italy;France;Mexico;Canada;Argentina;Belgium;Brazil;Australia;Germany;Japan;Korea, Republic of | ||
| 128 | EUCTR2020-000041-14-GB (EUCTR) | 19/06/2020 | 08/07/2020 | Treating people with Idiopathic Pulmonary fibrosis with the Addition of Lansoprazole | The effectiveness and risks of Treating people with Idiopathic Pulmonary fibrosis with the Addition of Lansoprazole (TIPAL): a randomised placebo-controlled multi-centre clinical trial - TIPAL | Idiopathic Pulmonary Fibrosis MedDRA version: 21.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Trade Name: Lansoprazole Product Name: Lansoprazole INN or Proposed INN: lansoprazole Other descriptive name: N/A | Norfolk and Norwich University Hospitals NHS Foundation Trust | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 298 | Phase 3 | United Kingdom | ||
| 129 | EUCTR2018-002664-73-IE (EUCTR) | 25/05/2020 | 20/12/2018 | Clinical study of the inhaled research drug GB0139 to test its effectiveness and safety in patients with a serious scarring disease of the lung over 52 weeks. | GALACTIC-1- A randomized, double-blind, multicentre, parallel, placebo-controlled Phase 2b study in subjects with idiopathic pulmonary fibrosis (IPF) investigating the efficacy and safety of GB0139, an inhaled galectin-3 inhibitor administered via a dry powder inhaler over 52 weeks | Patients with idiopathic pulmonary fibrosis (IPF) MedDRA version: 21.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders MedDRA version: 20.0;Level: LLT;Classification code 10067761;Term: Exacerbation of idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Body processes [G] - Circulatory and Respiratory Physiological Phenomena [G09] | Product Name: GB0139 (previously known as TD139) Product Code: GB0139 (previously known as TD139) INN or Proposed INN: GB0139 (previously known as TD139) Other descriptive name: DEX284 | Galecto Biotech AB | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 210 | Phase 2 | United States;Spain;Ukraine;Ireland;Israel;Russian Federation;United Kingdom;Italy;France;Canada;Belgium;Poland;Australia;Georgia;Germany | ||
| 130 | EUCTR2019-003571-19-GB (EUCTR) | 21/05/2020 | 27/02/2020 | A multicentre, double blind, placebo controlled, crossover trial of morphine sulphate sulfate for the treatment of PulmonAry Fibrosis Cough (PAciFy Cough Trial) | PAciFy Cough: A multicentre, double blind, placebo controlled, crossover trial of morphine sulfate for the treatment of PulmonAry Fibrosis Cough - PACIFY Cough | Idiopathic pulmonary fibrosis MedDRA version: 21.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Trade Name: Morphine Sulfate Product Name: Morphine Sulfate INN or Proposed INN: morphine sulfate | Royal Brompton and Harefield NHS Foundation Trust | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 44 | Phase 3 | United Kingdom | ||
| 131 | EUCTR2019-004167-45-FI (EUCTR) | 18/05/2020 | 15/04/2020 | A study to test how taking BI 1015550 for 12 weeks affects lungfunction in people with idiopathic pulmonary fibrosis (IPF). | A randomised, double-blind, placebo-controlled parallel groupstudy in IPF patients over 12 weeks evaluating efficacy, safety andtolerability of BI 1015550 taken orally. | Idiopathic Pulmonary Fibrosis MedDRA version: 21.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Code: BI 1015550 INN or Proposed INN: BI 1015550 Other descriptive name: BI 1015550 Product Code: BI 1015550 INN or Proposed INN: BI 1015550 Other descriptive name: BI 1015550 | Boehringer Ingelheim Finland Ky | NULL | Not Recruiting | Female: yes Male: yes | 150 | Phase 2 | United States;Slovakia;Greece;Spain;Ukraine;Chile;Russian Federation;Italy;Denmark;Australia;Netherlands;China;Korea, Republic of;Czechia;Finland;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Germany;Japan | ||
| 132 | EUCTR2019-004326-19-FR (EUCTR) | 27/01/2020 | 13/11/2019 | Management of Progressive Disease in Idiopathic Pulmonary Fibrosis | Pragmatic management of progressive disease in idiopathic pulmonary fibrosis: a randomized trial - PROGRESSION-IPF | Idiopathic pulmonary fibrosis MedDRA version: 21.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders ;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Trade Name: pirfenidone INN or Proposed INN: PIRFENIDONE Trade Name: nintedanib Other descriptive name: NINTEDANIB | Hospices Civils de Lyon | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 378 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | France | ||
| 133 | NCT04233814 (ClinicalTrials.gov) | January 20, 2020 | 12/1/2020 | Safety, Tolerability and Pharmacokinetic Study of LTI-03 in Healthy Adult Subjects | A Randomized, Double-Blind, Placebo-Controlled, Ph 1a, First-in-Man, Single Ascending Dose & Multiple Ascending Dose Safety, Tolerability and PK Study of a Caveolin-1-Scaffolding-Protein-Derived Peptide (LTI-03) in Healthy Adult Subjects | Idiopathic Pulmonary Fibrosis | Drug: Caveolin-1-Scaffolding-Protein-Derived Peptide (LTI-03);Drug: Placebo | Lung Therapeutics, Inc | NULL | Completed | 18 Years | 55 Years | All | 71 | Phase 1 | United Kingdom |
| 134 | ChiCTR2000037602 | 2020-01-01 | 2020-08-29 | Clinical observation and study of pirfenidone combined with dextromethorphan on idiopathic pulmonary fibrosis | Clinical observation and study of pirfenidone combined with dextromethorphan on idiopathic pulmonary fibrosis | Interstitial lung disease | 1:Dextromethorphan+Pirfenidone;2:Pirfenidone; | Tianjin Medical University General Hospital | NULL | Recruiting | 18 | 75 | Both | 1:100;2:100; | Phase 4 | China |
| 135 | JPRN-UMIN000039027 | 2019/12/26 | 27/12/2019 | Real world multicenter prospective study of combination therapy of anti-fibrotic agents in idiopathic pulmonary fibrosis(J-AVENGERS) | Real world multicenter prospective study of combination therapy of anti-fibrotic agents in idiopathic pulmonary fibrosis(J-AVENGERS) - J-AVENGERS | idiopathic pulmonary fibrosis | 48 weeks of observational period, administration of nintedanib, 100mg or 150mg twice a day and pirfenidone, 200mg, 400mg, or 600mg 3 times a day | Japanese Red Cross Medical Canter | NULL | Recruiting | 40years-old | Not applicable | Male and Female | 35 | Not selected | Japan |
| 136 | NCT04244825 (ClinicalTrials.gov) | December 15, 2019 | 3/1/2020 | Safety, Pharmacodynamics, and Pharmacokinetics of Orally Administered BLD-2660 in Subjects With IPF | A Phase 2a, Double-Blind, Placebo-Controlled Study to Evaluate Pharmacodynamics, Pharmacokinetics, and Safety of BLD-2660 Administered Orally in Subjects With Idiopathic Pulmonary Fibrosis | Idiopathic Pulmonary Fibrosis | Drug: BLD-2660;Drug: Control: Placebo | Blade Therapeutics | NULL | Withdrawn | 45 Years | N/A | All | 0 | Phase 2 | United Kingdom |
| 137 | NCT04720443 (ClinicalTrials.gov) | November 22, 2019 | 30/12/2020 | A Safety, Tolerability, and Pharmacokinetic Study of NIP292 in Healthy Normal Subjects | A Phase 1, Two-Part Study of NIP292 Tablets in Healthy Adult Subjects: Part 1 - Randomized, Double-Blind, Placebo-Controlled Assessment of Safety, Tolerability and Pharmacokinetics of Single Ascending Oral Doses; Part 2 - Randomized, Double-Blind, Placebo-Controlled Assessment of Safety, Tolerability and Pharmacokinetics of Multiple Ascending Oral Doses. | Idiopathic Pulmonary Fibrosis | Drug: NIP292 tablet;Drug: NIP292 tablets | The National Institutes of Pharmaceutical R&D Co. Ltd, China | NULL | Recruiting | 18 Years | 55 Years | All | 72 | Phase 1 | United States |
| 138 | JPRN-jRCTs031190119 | 28/10/2019 | 18/10/2019 | A phase II Study of CBDCA + ETP + Nintedanib for SCLC with IPF | A Phase II Study of Carboplatin and Etoposide Plus Nintedanib for Unresectable Limited/Extensive Disease Small Cell Lung Cancer with Idiopathic Pulmonary Fibrosis - TORG1835 / NEXT-SHIP | Unresectable limited or extensive disease small cell lung cancer with idiopathic pulmonary fibrosis | The patients receive carboplatin(area under the curve 5 mg/mL, intravenously, day 1), etoposide (<75 years old:100mg/m2:>=75years old:80mg/m2;intravenously,days 1-3), and nintedanib (150mg twice a day, orally). The patients receive combination chemotherapy every3 weeks for 4 cycles until disease progression or unacceptable toxicity occurs. After completion or discontinuation of carboplatin plus etoposide, the patients continue nintedanib until the discontinuation criteria are satisfied. | IKEDA Satoshi | OGURA Takashi;Thoracic Oncology Research Group | Not Recruiting | >= 20age old | Not applicable | Both | 33 | Phase 2 | Japan |
| 139 | ChiCTR1900027121 | 2019-10-28 | 2019-11-01 | The efficacy and safety of immunosuppressant in the treatment of nonspecific interstitial pneumonia (NSIP): a prospective, single-center, open, parallel-controlled trial | The efficacy and safety of immunosuppressant in the treatment of nonspecific interstitial pneumonia (NSIP): a prospective, single-center, open, parallel-controlled trial | nonspecific interstitial pneumonia (NSIP) | Group-1:Mycophenolate mofetil dispersible tablets 2 g /d; Steroid 0.75 mg/kg/d;Group-2:Tacrolimus capsule, 3mg/d, Steroid 0.75 mg/kg/d;Group-3:Cyclophosphamide 1-2mg/kg/d, Steroid 0.75 mg/kg/d;Control group:Steroid from 0.75 mg/kg/d to 15 mg/d.; | Peking Union Medical College Hospital | NULL | Recruiting | 18 | 75 | Both | Group-1:30;Group-2:30;Group-3:30;Control group:30; | Phase 4 | China |
| 140 | EUCTR2018-002664-73-GB (EUCTR) | 24/09/2019 | 22/01/2019 | Clinical study of the inhaled research drug TD139 to test its effectiveness and safety in patients with a serious scarring disease of the lung over 52 weeks. | GALACTIC-1- A randomized, double-blind, multicentre, parallel, placebo-controlled Phase 2b study in subjects with idiopathic pulmonary fibrosis (IPF) investigating the efficacy and safety of TD139, an inhaled galectin-3 inhibitor administered via a dry powder inhaler over 52 weeks | patients with idiopathic pulmonary fibrosis (IPF) MedDRA version: 21.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders MedDRA version: 20.0;Level: LLT;Classification code 10067761;Term: Exacerbation of idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Body processes [G] - Circulatory and Respiratory Physiological Phenomena [G09] | Product Name: TD139 Product Code: TD139 INN or Proposed INN: TD139 Other descriptive name: DEX284 Product Name: TD139 Product Code: TD139 INN or Proposed INN: TD139 Other descriptive name: DEX284 | Galecto Biotech AB | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 450 | Phase 2 | United States;France;Canada;Spain;Poland;Belgium;Ireland;Israel;Germany;Italy;United Kingdom | ||
| 141 | NCT04072315 (ClinicalTrials.gov) | September 9, 2019 | 23/8/2019 | Phase 2a Evaluation of PLN-74809 on avß6 Receptor Occupancy Using PET Imaging in Participants With IPF/ | A Phase 2a Evaluation of PLN-74809 on avß6 Receptor Occupancy Using PET Imaging in Participants With IPF | Idiopathic Pulmonary Fibrosis | Drug: PLN-74809;Radiation: Knottin tracer | Pliant Therapeutics, Inc. | Stanford University | Completed | 40 Years | N/A | All | 12 | Phase 2 | United States |
| 142 | JPRN-jRCTs031190084 | 05/09/2019 | 27/08/2019 | TORG1936 / AMBITIOUS study | A phase II study of Atezolizumab for advanced / recurrent Non-Small Cell Lung Cancer with Idiopathic Interstitial Pneumonias - TORG1936 / AMBITIOUS study | Advanced / recurrent Non-small cell lung cancer with idiopathic interstitial pneumonia | Atezolizumab 1200mg, every 3 weeks | KATO Terufumi | IKEDA Satoshi | Complete | >= 20age old | Not applicable | Both | 38 | Phase 2 | Japan |
| 143 | EUCTR2017-004302-18-RO (EUCTR) | 30/08/2019 | 24/05/2022 | A clinical study to test how effective and safe GLPG1205 is for patients with Idiopathic Pulmonary Fibrosis (IPF) | A Phase II randomized, double-blind, placebo-controlled, 26-week study to evaluate the efficacy, safety and tolerability of GLPG1205 in subjects with idiopathic pulmonary fibrosis. | Idiopathic pulmonary fibrosis MedDRA version: 21.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: GLPG1205 Product Code: G321605 INN or Proposed INN: NA Other descriptive name: GLPG1205 | Galapagos NV | NULL | Not Recruiting | Female: yes Male: yes | 60 | Phase 2 | France;Egypt;Slovakia;Finland;Ukraine;Oman;Croatia;Romania;Bulgaria;Sweden | ||
| 144 | NCT04030026 (ClinicalTrials.gov) | August 8, 2019 | 11/7/2019 | A Study of Nalbuphine (Extended Release) ER in Idiopathic Pulmonary Fibrosis (IPF) for Treatment of Cough | Phase 2, Double-blind, Randomized, Placebo-controlled, Two-Treatment, Two-Period Crossover Efficacy and Safety Study in Idiopathic Pulmonary Fibrosis (IPF) With Nalbuphine ER Tablets for the Treatment of Cough | Nalbuphine;Idiopathic Pulmonary Fibrosis;Cough | Drug: Nalbuphine ER;Drug: Placebo oral tablet | Trevi Therapeutics | Parexel | Completed | 18 Years | 80 Years | All | 42 | Phase 2 | United Kingdom |
| 145 | EUCTR2018-002664-73-IT (EUCTR) | 17/07/2019 | 15/01/2021 | Clinical study of the inhaled research drug TD139 to test its effectiveness and safety in patients with a serious scarring disease of the lung over 52 weeks. | GALACTIC-1- A randomized, double-blind, multicentre, parallel, placebo-controlled Phase 2b study in subjects with idiopathic pulmonary fibrosis (IPF) investigating the efficacy and safety of TD139, an inhaled galectin-3 inhibitor administered via a dry powder inhaler over 52 weeks - - | patients with idiopathic pulmonary fibrosis (IPF) MedDRA version: 21.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders MedDRA version: 20.0;Level: LLT;Classification code 10067761;Term: Exacerbation of idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Body processes [G] - Circulatory and Respiratory Physiological Phenomena [G09] | Product Name: TD139 Product Code: [TD139] INN or Proposed INN: TD139 Other descriptive name: DEX284 Product Name: TD139 Product Code: [TD139] INN or Proposed INN: TD139 Other descriptive name: DEX284 | Galecto Biotech AB | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 450 | Phase 2 | France;United States;Canada;Spain;Poland;Belgium;Ireland;Israel;Germany;United Kingdom;Italy | ||
| 146 | EUCTR2018-002664-73-FR (EUCTR) | 09/07/2019 | 22/01/2019 | Clinical study of the inhaled research drug TD139 to test its effectiveness and safety in patients with a serious scarring disease of the lung over 52 weeks. | GALACTIC-1- A randomized, double-blind, multicentre, parallel, placebo-controlled Phase 2b study in subjects with idiopathic pulmonary fibrosis (IPF) investigating the efficacy and safety of TD139, an inhaled galectin-3 inhibitor administered via a dry powder inhaler over 52 weeks | patients with idiopathic pulmonary fibrosis (IPF) MedDRA version: 20.0;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders MedDRA version: 20.0;Level: LLT;Classification code 10067761;Term: Exacerbation of idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders ;Therapeutic area: Body processes [G] - Circulatory and Respiratory Physiological Phenomena [G09] | Product Name: TD139 Product Code: TD139 INN or Proposed INN: TD139 Other descriptive name: DEX284 Product Name: TD139 Product Code: TD139 INN or Proposed INN: TD139 Other descriptive name: DEX284 | Galecto Biotech AB | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 450 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | United States;France;Canada;Poland;Belgium;Spain;Israel;Germany;Italy;United Kingdom | ||
| 147 | EUCTR2018-002664-73-PL (EUCTR) | 09/07/2019 | 14/03/2019 | Clinical study of the inhaled research drug GB0139 to test its effectiveness and safety in patients with a serious scarring disease of the lung over 52 weeks. | GALACTIC-1- A randomized, double-blind, multicentre, parallel, placebo-controlled Phase 2b study in subjects with idiopathic pulmonary fibrosis (IPF) investigating the efficacy and safety of GB0139, an inhaled galectin-3 inhibitor administered via a dry powder inhaler over 52 weeks | patients with idiopathic pulmonary fibrosis (IPF) MedDRA version: 21.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders MedDRA version: 20.0;Level: LLT;Classification code 10067761;Term: Exacerbation of idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Body processes [G] - Circulatory and Respiratory Physiological Phenomena [G09] | Product Name: GB0139 (previously known as TD139) Product Code: GB0139 (previously known as TD139) INN or Proposed INN: GB0139 (previously known as TD139) Other descriptive name: DEX284 | Galecto Biotech AB | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 141 | Phase 2 | United States;Spain;Ukraine;Ireland;Israel;Russian Federation;United Kingdom;Italy;France;Canada;Poland;Belgium;Australia;Georgia;Germany | ||
| 148 | NCT03562416 (ClinicalTrials.gov) | July 5, 2019 | 7/5/2018 | Continuation of Nintedanib After Single Lung Transplantation in IPF Subjects | Nintedanib Plus Usual Transplant Care Compared to Usual Transplant Care Alone After Single Lung Transplantation in Patients With Idiopathic Pulmonary Fibrosis: a Pilot Randomized Controlled Trial | Idiopathic Pulmonary Fibrosis;Lung Transplant; Complications | Drug: Nintedanib;Drug: Placebo Oral Tablet | Temple University | Boehringer Ingelheim | Recruiting | 35 Years | 70 Years | All | 20 | Phase 2 | United States |
| 149 | EUCTR2018-004447-23-DE (EUCTR) | 04/07/2019 | 07/03/2019 | Efficacy and Safety Study with Inhaled RVT-1601 for the Treatment of Persistent Cough in Patients with Idiopathic Pulmonary Fibrosis (IPF) | Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging, Efficacy and Safety Study with Inhaled RVT-1601 for the Treatment of Persistent Cough in Patients with Idiopathic Pulmonary Fibrosis (IPF): SCENIC Trial - SCENIC Trial | Persistent cough in Idiopathic Pulmonary Fibrosis (IPF) MedDRA version: 21.1;Level: LLT;Classification code 10070801;Term: Persistent cough;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: Cromolyn sodium [Disodium Cromoglycate] Product Code: RVT-1601 (formerly, PA101B) INN or Proposed INN: SODIUM CROMOGLICATE Other descriptive name: SODIUM CROMOGLICATE Product Name: Cromolyn sodium [Disodium Cromoglycate] Product Code: RVT-1601 (formerly, PA101B) INN or Proposed INN: SODIUM CROMOGLICATE Other descriptive name: SODIUM CROMOGLICATE Product Name: Cromolyn sodium [Disodium Cromoglycate] Product Code: RVT-1601 (formerly, PA101B) INN or Proposed INN: SODIUM CROMOGLICATE Other descriptive name: SODIUM CROMOGLICATE | Respivant Sciences GmbH | NULL | Not Recruiting | Female: yes Male: yes | 180 | Phase 2 | United States;Czech Republic;Canada;Belgium;Turkey;Netherlands;Germany;United Kingdom;Italy | ||
| 150 | EUCTR2018-004744-31-GB (EUCTR) | 24/06/2019 | 05/03/2019 | Efficacy and Safety Study: Nalbuphine ER Tablets for the Treatment of Cough in Idiopathic Pulmonary Fibrosis | A Phase 2, Double-Blind, Randomized, Placebo-Controlled, Two-Treatment, Two-Period Crossover Efficacy and Safety Study in Idiopathic Pulmonary Fibrosis With Nalbuphine ER Tablets for the Treatment of Cough - CANAL | Treatment of Cough in Idiopathic Pulmonary Fibrosis;Therapeutic area: Body processes [G] - Circulatory and Respiratory Physiological Phenomena [G09] | Product Name: Nalbuphine Extended-Realease (ER) Tablets Product Code: TR0311 INN or Proposed INN: Nalbuphine Other descriptive name: NALBUPHINE HYDROCHLORIDE Product Name: Nalbuphine Extended-Release (ER) Tablets Product Code: TR0311 INN or Proposed INN: Nalbuphine Other descriptive name: NALBUPHINE HYDROCHLORIDE Product Name: Nalbuphine Extended-Release (ER) Tablets Product Code: TR0311 INN or Proposed INN: Nalbuphine Other descriptive name: NALBUPHINE HYDROCHLORIDE Product Name: Nalbuphine Extended-Release (ER) Tablets Product Code: TR0311 INN or Proposed INN: Nalbuphine Other descriptive name: NALBUPHINE HYDROCHLORIDE | Trevi Therapeutics, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 60 | Phase 2 | United Kingdom | ||
| 151 | NCT03955146 (ClinicalTrials.gov) | June 18, 2019 | 16/5/2019 | Zephyrus I: Evaluation of Efficacy and Safety of Pamrevlumab in Participants With Idiopathic Pulmonary Fibrosis (IPF) | A Phase 3, Randomized, Double-Blind, Placebo-Controlled Efficacy and Safety Study of Pamrevlumab in Subjects With Idiopathic Pulmonary Fibrosis (IPF) | Idiopathic Pulmonary Fibrosis | Drug: Pamrevlumab;Drug: Placebo | FibroGen | NULL | Active, not recruiting | 40 Years | 85 Years | All | 356 | Phase 3 | United States;Argentina;Australia;Chile;China;Hong Kong;Korea, Republic of;Russian Federation;Taiwan;Czechia;France;Germany;Hungary;Italy;Japan;Lebanon;Netherlands;Peru;Spain |
| 152 | EUCTR2018-004447-23-IT (EUCTR) | 18/06/2019 | 10/11/2020 | Efficacy and Safety Study with Inhaled RVT-1601 for the Treatment of Persistent Cough in Patients with Idiopathic Pulmonary Fibrosis (IPF) | Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging, Efficacy and Safety Study with Inhaled RVT-1601 for the Treatment of Persistent Cough in Patients with Idiopathic Pulmonary Fibrosis (IPF): SCENIC Trial - SCENIC Trial | Persistent cough in Idiopathic Pulmonary Fibrosis (IPF) MedDRA version: 21.1;Level: LLT;Classification code 10070801;Term: Persistent cough;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: cromolyn sodio (cromoglicato disodico, DSCG) Product Code: [RVT-1601 (in precedenza PA101B)] INN or Proposed INN: cromoglicato disodico Other descriptive name: SODIUM CROMOGLICATE Product Name: cromolyn sodio (cromoglicato disodico, DSCG) Product Code: [RVT-1601 (in precedenza PA101B)] INN or Proposed INN: cromoglicato disodico Other descriptive name: SODIUM CROMOGLICATE Product Name: cromolyn sodio (cromoglicato disodico, DSCG) Product Code: [RVT-1601 (in precedenza PA101B)] INN or Proposed INN: cromoglicato disodico Other descriptive name: SODIUM CROMOGLICATE | Respivant Sciences, GmbH | NULL | Not Recruiting | Female: yes Male: yes | 180 | Phase 2 | United States;Czechia;Czech Republic;Canada;Belgium;Turkey;Australia;Netherlands;Germany;United Kingdom;New Zealand;Italy | ||
| 153 | EUCTR2018-001405-87-BE (EUCTR) | 27/05/2019 | 28/11/2018 | A clinical study to test how effective and safe GLPG1690 is for subjects with idiopathic pulmonary fibrosis (IPF) when used together with standard medical treatment | A Phase 3, randomized, double-blind, parallel-group, placebo-controlled, multi-center study to evaluate the efficacy and safety of two doses of GLPG1690 in addition to local standard of care for minimum 52 weeks in subjects with idiopathic pulmonary fibrosis. | Idiopatic pulmonary fibrosis MedDRA version: 20.0;Level: SOC;Classification code 10038738;Term: Respiratory, thoracic and mediastinal disorders;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: GLPG1690 Product Code: G451990 INN or Proposed INN: ziritaxestat Other descriptive name: GLPG1690 Product Name: GLPG1690 Product Code: G451990 INN or Proposed INN: ziritaxestat Other descriptive name: GLPG1690 | Galapagos NV | NULL | Not Recruiting | Female: yes Male: yes | 750 | Phase 3 | United States;Taiwan;Greece;Finland;Spain;Turkey;Chile;United Kingdom;Czech Republic;Belgium;Brazil;Australia;Denmark;Peru;Germany | ||
| 154 | EUCTR2018-004447-23-GB (EUCTR) | 20/05/2019 | 15/03/2019 | Efficacy and Safety Study with Inhaled RVT-1601 for the Treatment of Persistent Cough in Patients with Idiopathic Pulmonary Fibrosis (IPF) | Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging, Efficacy and Safety Study with Inhaled RVT-1601 for the Treatment of Persistent Cough in Patients with Idiopathic Pulmonary Fibrosis (IPF): SCENIC Trial - SCENIC Trial RESPIVANT RVT1601-cc-04 | Persistent cough in Idiopathic Pulmonary Fibrosis (IPF) MedDRA version: 21.1;Level: LLT;Classification code 10070801;Term: Persistent cough;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: Cromolyn sodium [Disodium Cromoglycate] Product Code: RVT-1601 (formerly, PA101B) INN or Proposed INN: SODIUM CROMOGLICATE Other descriptive name: SODIUM CROMOGLICATE | Respivant Sciences GmbH | NULL | Not Recruiting | Female: yes Male: yes | 180 | Phase 2 | United States;Czech Republic;Canada;Belgium;Turkey;Australia;Netherlands;Germany;New Zealand;Italy;United Kingdom | ||
| 155 | EUCTR2018-004447-23-CZ (EUCTR) | 15/05/2019 | 14/03/2019 | Efficacy and Safety Study with Inhaled RVT-1601 for the Treatment of Persistent Cough in Patients with Idiopathic Pulmonary Fibrosis (IPF) | Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging, Efficacy and Safety Study with Inhaled RVT-1601 for the Treatment of Persistent Cough in Patients with Idiopathic Pulmonary Fibrosis (IPF): SCENIC Trial - SCENIC Trial | Persistent cough in Idiopathic Pulmonary Fibrosis (IPF) MedDRA version: 21.1;Level: LLT;Classification code 10070801;Term: Persistent cough;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: Cromolyn sodium [Disodium Cromoglycate] Product Code: RVT-1601 (formerly, PA101B) INN or Proposed INN: SODIUM CROMOGLICATE Other descriptive name: SODIUM CROMOGLICATE Product Name: Cromolyn sodium [Disodium Cromoglycate] Product Code: RVT-1601 (formerly, PA101B) INN or Proposed INN: SODIUM CROMOGLICATE Other descriptive name: SODIUM CROMOGLICATE Product Name: Cromolyn sodium [Disodium Cromoglycate] Product Code: RVT-1601 (formerly, PA101B) INN or Proposed INN: SODIUM CROMOGLICATE Other descriptive name: SODIUM CROMOGLICATE | Respivant Sciences GmbH | NULL | Not Recruiting | Female: yes Male: yes | 180 | Phase 2 | United States;Czech Republic;Canada;Belgium;Turkey;Australia;Netherlands;Germany;United Kingdom;New Zealand;Italy | ||
| 156 | NCT03981094 (ClinicalTrials.gov) | May 10, 2019 | 21/5/2019 | A Study of the Pharmacokinetic Interaction Between Pirfenidone and BMS-986278 in Healthy Participants | An Open Label Study to Assess the Pharmacokinetic Interaction Between Pirfenidone and BMS-986278 Following a Single Oral Dose Administration in Healthy Participants | Idiopathic Pulmonary Fibrosis (IPF) | Drug: BMS-986278;Drug: Pirfenidone | Bristol-Myers Squibb | NULL | Completed | 21 Years | 65 Years | All | 22 | Phase 1 | United States |
| 157 | EUCTR2018-004447-23-BE (EUCTR) | 02/05/2019 | 01/04/2019 | Efficacy and Safety Study with Inhaled RVT-1601 for the Treatment of Persistent Cough in Patients with Idiopathic Pulmonary Fibrosis (IPF) | Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging, Efficacy and Safety Study with Inhaled RVT-1601 for the Treatment of Persistent Cough in Patients with Idiopathic Pulmonary Fibrosis (IPF): SCENIC Trial - SCENIC Trial | Persistent cough in Idiopathic Pulmonary Fibrosis (IPF) MedDRA version: 21.1;Level: LLT;Classification code 10070801;Term: Persistent cough;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: Cromolyn sodium [Disodium Cromoglycate] Product Code: RVT-1601 (formerly, PA101B) INN or Proposed INN: SODIUM CROMOGLICATE Other descriptive name: SODIUM CROMOGLICATE Product Name: Cromolyn sodium [Disodium Cromoglycate] Product Code: RVT-1601 (formerly, PA101B) INN or Proposed INN: SODIUM CROMOGLICATE Other descriptive name: SODIUM CROMOGLICATE Product Name: Cromolyn sodium [Disodium Cromoglycate] Product Code: RVT-1601 (formerly, PA101B) INN or Proposed INN: SODIUM CROMOGLICATE Other descriptive name: SODIUM CROMOGLICATE | Respivant Sciences GmbH | NULL | Not Recruiting | Female: yes Male: yes | 180 | Phase 2 | United States;Czech Republic;Canada;Belgium;Turkey;Australia;Netherlands;Germany;United Kingdom;New Zealand;Italy | ||
| 158 | EUCTR2017-003158-18-DE (EUCTR) | 30/04/2019 | 21/06/2018 | Evaluating the Efficacy and Safety of BG00011 in Participants with Idiopathic Pulmonary Fibrosis | A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of BG00011 in Patients With Idiopathic Pulmonary Fibrosis - SPIRIT | mild to moderate Idiopathic Pulmonary Fibrosis MedDRA version: 20.0;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders ;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: humanized anti-alpha v beta 6 mAb Product Code: BG00011 INN or Proposed INN: Not yet assigned Other descriptive name: BG00011 | Biogen Idec Research Limited | NULL | Not Recruiting | Female: yes Male: yes | 290 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | United States;Greece;Spain;Turkey;Russian Federation;Israel;Italy;United Kingdom;France;Czech Republic;Canada;Argentina;Poland;Belgium;Australia;Denmark;Netherlands;Germany;Korea, Republic of | ||
| 159 | NCT03949530 (ClinicalTrials.gov) | April 16, 2019 | 6/5/2019 | A Study of Safety & Blood Levels of IDL-2965 in Healthy Subjects and Patients With a Special Type of Pulmonary Fibrosis | IDL-2965 - A Phase I, Randomized, Double-blind, Placebo-controlled, Single and Multiple Oral Dose, Safety, Tolerability, and Pharmacokinetic Study in Healthy Subjects and Subjects With Idiopathic Pulmonary Fibrosis (IPF) | Healthy Volunteers;Idiopathic Pulmonary Fibrosis | Drug: IDL-2965 Oral Capsule;Drug: Placebos | Indalo Therapeutics, Inc. | NULL | Terminated | 18 Years | 60 Years | All | 6 | Phase 1 | United Kingdom |
| 160 | EUCTR2018-004447-23-NL (EUCTR) | 16/04/2019 | 07/03/2019 | Efficacy and Safety Study with Inhaled RVT-1601 for the Treatment of Persistent Cough in Patients with Idiopathic Pulmonary Fibrosis (IPF) | Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging, Efficacy and Safety Study with Inhaled RVT-1601 for the Treatment of Persistent Cough in Patients with Idiopathic Pulmonary Fibrosis (IPF): SCENIC Trial - SCENIC Trial | Persistent cough in Idiopathic Pulmonary Fibrosis (IPF) MedDRA version: 21.1;Level: LLT;Classification code 10070801;Term: Persistent cough;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: Cromolyn sodium [Disodium Cromoglycate] Product Code: RVT-1601 (formerly, PA101B) INN or Proposed INN: SODIUM CROMOGLICATE Other descriptive name: SODIUM CROMOGLICATE | Respivant Sciences GmbH | NULL | Not Recruiting | Female: yes Male: yes | 180 | Phase 2 | United States;Czechia;Czech Republic;Canada;Belgium;Turkey;Australia;Germany;Netherlands;United Kingdom;Italy;New Zealand | ||
| 161 | EUCTR2018-002664-73-ES (EUCTR) | 08/04/2019 | 12/04/2019 | Clinical study of the inhaled research drug TD139 to test its effectiveness and safety in patients with a serious scarring disease of the lung over 52 weeks. | GALACTIC-1- A randomized, double-blind, multicentre, parallel, placebo-controlled Phase 2b study in subjects with idiopathic pulmonary fibrosis (IPF) investigating the efficacy and safety of TD139, an inhaled galectin-3 inhibitor administered via a dry powder inhaler over 52 weeks | patients with idiopathic pulmonary fibrosis (IPF) MedDRA version: 20.0;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders MedDRA version: 20.0;Level: LLT;Classification code 10067761;Term: Exacerbation of idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders ;Therapeutic area: Body processes [G] - Circulatory and Respiratory Physiological Phenomena [G09] | Product Name: TD139 Product Code: TD139 INN or Proposed INN: TD139 Other descriptive name: DEX284 Product Name: TD139 Product Code: TD139 INN or Proposed INN: TD139 Other descriptive name: DEX284 | Galecto Biotech AB | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 450 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | France;United States;Canada;Poland;Belgium;Spain;Ireland;Israel;Germany;Italy;United Kingdom | ||
| 162 | EUCTR2018-001406-29-NL (EUCTR) | 03/04/2019 | 06/12/2018 | A clinical study to test how effective and safe GLPG1690 is for subjects with idiopathic pulmonary fibrosis (IPF) when used together with standard medical treatment | A Phase 3, randomized, double-blind, parallel-group, placebo-controlled, multi-center study to evaluate the efficacy and safety of two doses of GLPG1690 in addition to local standard of care for minimum 52 weeks in subjects with idiopathic pulmonary fibrosis. | Idiopatic pulmonary fibrosis MedDRA version: 20.0;Level: SOC;Classification code 10038738;Term: Respiratory, thoracic and mediastinal disorders;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: GLPG1690 Product Code: G451990 INN or Proposed INN: Not applicable Other descriptive name: GLPG1690 Product Name: GLPG1690 Product Code: G451990 INN or Proposed INN: Not applicable Other descriptive name: GLPG1690 | Galapagos NV | NULL | Not Recruiting | Female: yes Male: yes | 750 | Phase 3 | United States;Israel;Italy;France;Hungary;Mexico;Canada;Argentina;Poland;Brazil;South Africa;Netherlands;Germany;Japan;New Zealand;Korea, Republic of | ||
| 163 | NCT03864328 (ClinicalTrials.gov) | March 29, 2019 | 2/3/2019 | A Phase 2b Study of Inhaled RVT-1601 for the Treatment of Persistent Cough in IPF | Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging, Efficacy and Safety Study With Inhaled RVT-1601 for the Treatment of Persistent Cough in Patients With Idiopathic Pulmonary Fibrosis (IPF): SCENIC Trial | Persistent Cough in IPF;Chronic Cough;IPF | Drug: RVT-1601;Drug: Placebo | Respivant Sciences GmbH | Respivant Sciences Inc. | Terminated | 40 Years | 89 Years | All | 108 | Phase 2 | United States;Australia;Belgium;Canada;Czechia;Germany;Italy;Netherlands;New Zealand;Turkey;United Kingdom |
| 164 | EUCTR2018-001405-87-GB (EUCTR) | 29/03/2019 | 05/12/2018 | A clinical study to test how effective and safe GLPG1690 is for subjects with idiopathic pulmonary fibrosis (IPF) when used together with standard medical treatment | A Phase 3, randomized, double-blind, parallel-group, placebo-controlled, multi-center study to evaluate the efficacy and safety of two doses of GLPG1690 in addition to local standard of care for minimum 52 weeks in subjects with idiopathic pulmonary fibrosis. | Idiopatic pulmonary fibrosis MedDRA version: 20.0;Level: SOC;Classification code 10038738;Term: Respiratory, thoracic and mediastinal disorders;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: GLPG1690 Product Code: G451990 INN or Proposed INN: ziritaxestat Other descriptive name: GLPG1690 Product Name: GLPG1690 Product Code: G451990 INN or Proposed INN: ziritaxestat Other descriptive name: GLPG1690 | Galapagos NV | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 750 | Phase 3 | United States;Czechia;Taiwan;Greece;Finland;Spain;Turkey;Chile;United Kingdom;Czech Republic;Belgium;Brazil;Australia;Denmark;Peru;Germany | ||
| 165 | EUCTR2018-001405-87-DE (EUCTR) | 21/03/2019 | 26/11/2018 | A clinical study to test how effective and safe GLPG1690 is for subjects with idiopathic pulmonary fibrosis (IPF) when used together with standard medical treatment | A Phase 3, randomized, double-blind, parallel-group, placebo-controlled, multi-center study to evaluate the efficacy and safety of two doses of GLPG1690 in addition to local standard of care for minimum 52 weeks in subjects with idiopathic pulmonary fibrosis. | Idiopatic pulmonary fibrosis MedDRA version: 20.0;Level: SOC;Classification code 10038738;Term: Respiratory, thoracic and mediastinal disorders;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: GLPG1690 Product Code: G451990 INN or Proposed INN: ziritaxestat Other descriptive name: GLPG1690 Product Name: GLPG1690 Product Code: G451990 INN or Proposed INN: ziritaxestat Other descriptive name: GLPG1690 | Galapagos NV | NULL | Not Recruiting | Female: yes Male: yes | 750 | Phase 3 | United States;Taiwan;Greece;Finland;Spain;Turkey;Chile;United Kingdom;Czech Republic;Belgium;Brazil;Australia;Denmark;Peru;Germany | ||
| 166 | EUCTR2017-004302-18-FI (EUCTR) | 05/03/2019 | 04/09/2018 | A clinical study to test how effective and safe GLPG1205 is for patients with Idiopathic Pulmonary Fibrosis (IPF) | A Phase II randomized, double-blind, placebo-controlled, 26-week study to evaluate the efficacy, safety and tolerability of GLPG1205 in subjects with idiopathic pulmonary fibrosis. | Idiopathic pulmonary fibrosis MedDRA version: 21.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: GLPG1205 Product Code: G321605 INN or Proposed INN: NA Other descriptive name: GLPG1205 | Galapagos NV | NULL | Not Recruiting | Female: yes Male: yes | 60 | Phase 2 | France;Egypt;Slovakia;Finland;Ukraine;Oman;Romania;Croatia;Bulgaria;Sweden | ||
| 167 | NCT04564664 (ClinicalTrials.gov) | March 1, 2019 | 14/9/2020 | High-flow Oxygen Therapy During Exercise in Idiopathic Pulmonary Fibrosis | High-flow Oxygen Therapy During Exercise in Idiopathic Pulmonary Fibrosis: a Crossover Clinical Trial | Idiopathic Pulmonary Fibrosis | Drug: Oxygen | Parc de Salut Mar | Hospitales Universitarios Virgen del Rocío | Completed | 18 Years | 85 Years | All | 10 | N/A | Spain |
| 168 | NCT03650075 (ClinicalTrials.gov) | February 25, 2019 | 20/8/2018 | To Determine Safety and Tolerability of MG-S-2525 and to Evaluate Its PK Profile in Healthy Volunteers | A Phase I Study to Determine Safety and Tolerability of MG-S-2525 and to Evaluate Its Pharmacokinetic Profile in Healthy Volunteers | Idiopathic Pulmonary Fibrosis (IPF) | Drug: MG-S-2525 | Metagone Biotech Inc. | NULL | Completed | 20 Years | N/A | All | 81 | Phase 1 | Taiwan |
| 169 | EUCTR2018-001405-87-GR (EUCTR) | 21/02/2019 | 22/01/2019 | A clinical study to test how effective and safe GLPG1690 is for subjects with idiopathic pulmonary fibrosis (IPF) when used together with standard medical treatment | A Phase 3, randomized, double-blind, parallel-group, placebo-controlled, multi-center study to evaluate the efficacy and safety of two doses of GLPG1690 in addition to local standard of care for minimum 52 weeks in subjects with idiopathic pulmonary fibrosis. | Idiopatic pulmonary fibrosis MedDRA version: 20.0;Level: SOC;Classification code 10038738;Term: Respiratory, thoracic and mediastinal disorders;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: GLPG1690 Product Code: G451990 INN or Proposed INN: ziritaxestat Other descriptive name: GLPG1690 Product Name: GLPG1690 Product Code: G451990 INN or Proposed INN: ziritaxestat Other descriptive name: GLPG1690 | Galapagos NV | NULL | Not Recruiting | Female: yes Male: yes | 750 | Phase 3 | United States;Taiwan;Greece;Finland;Spain;Turkey;Chile;United Kingdom;Czech Republic;Belgium;Brazil;Australia;Denmark;Peru;Germany | ||
| 170 | NCT03832946 (ClinicalTrials.gov) | February 19, 2019 | 4/2/2019 | A Study to Test the Efficacy and Safety of Inhaled GB0139 in Subjects With Idiopathic Pulmonary Fibrosis (IPF) | GALACTIC-1 -A Randomized, Double-blind, Multicentre, Parallel, Placebo-controlled Phase 2b Study in Subjects With Idiopathic Pulmonary Fibrosis (IPF) Investigating the Efficacy and Safety of GB0139, an Inhaled Galectin-3 Inhibitor Administered Via a Dry Powder Inhaler Over 52 Weeks | Idiopathic Pulmonary Fibrosis (IPF) | Drug: GB0139;Drug: Placebo | Galecto Biotech AB | Syneos Health;bioRASI, LLC | Active, not recruiting | 40 Years | N/A | All | 426 | Phase 2 | United States;Australia;Belgium;Canada;France;Georgia;Germany;Ireland;Israel;Italy;Poland;Spain;Ukraine;United Kingdom |
| 171 | EUCTR2017-003158-18-PL (EUCTR) | 18/02/2019 | 30/11/2018 | Evaluating the Efficacy and Safety of BG00011 in Participants with Idiopathic Pulmonary Fibrosis | A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of BG00011 in Patients With Idiopathic Pulmonary Fibrosis | mild to moderate Idiopathic Pulmonary Fibrosis MedDRA version: 21.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders ;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: humanized anti-alpha v beta 6 mAb Product Code: BG00011 INN or Proposed INN: Not yet assigned Other descriptive name: BG00011 | Biogen Idec Research Limited | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 290 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | United States;Greece;Spain;Turkey;Russian Federation;Israel;Italy;United Kingdom;France;Czech Republic;Canada;Argentina;Poland;Belgium;Australia;Denmark;Netherlands;Germany;Korea, Republic of | ||
| 172 | NCT03830125 (ClinicalTrials.gov) | February 13, 2019 | 31/1/2019 | Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of BBT-877 in Healthy Subjects | A Phase 1, 2-Stage, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of BBT-877 Following Single and Multiple Ascending Doses in Healthy Adult Subjects | Idiopathic Pulmonary Fibrosis | Drug: BBT-877, Single dose;Drug: Placebo group;Drug: BBT-877, Multiple doses | Bridge Biotherapeutics, Inc. | KCRN Research, LLC | Completed | 19 Years | 55 Years | All | 88 | Phase 1 | United States |
| 173 | NCT03958071 (ClinicalTrials.gov) | February 1, 2019 | 20/5/2019 | A Study Based on Medical Records That Looks at the Characteristics of Idiopathic Pulmonary Fibrosis Patients Grouped by the Type of Medication They Are Taking | Characteristics of IPF Patients Initiating Nintedanib, Pirfenidone or no Antifibrotic Treatment in the US | Idiopathic Pulmonary Fibrosis | Drug: Nintedanib;Drug: Pirfenidone;Other: Untreated Cohort | Boehringer Ingelheim | NULL | Completed | 40 Years | N/A | All | 13264 | United States | |
| 174 | EUCTR2018-001406-29-FR (EUCTR) | 28/01/2019 | 29/11/2018 | A clinical study to test how effective and safe GLPG1690 is for subjects with idiopathic pulmonary fibrosis (IPF) when used together with standard medical treatment | A Phase 3, randomized, double-blind, parallel-group, placebo-controlled, multi-center study to evaluate the efficacy and safety of two doses of GLPG1690 in addition to local standard of care for minimum 52 weeks in subjects with idiopathic pulmonary fibrosis. | Idiopatic pulmonary fibrosis MedDRA version: 20.0;Level: SOC;Classification code 10038738;Term: Respiratory, thoracic and mediastinal disorders;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: GLPG1690 Product Code: G451990 INN or Proposed INN: Not applicable Other descriptive name: GLPG1690 Product Name: GLPG1690 Product Code: G451990 INN or Proposed INN: Not applicable Other descriptive name: GLPG1690 | Galapagos NV | NULL | Not Recruiting | Female: yes Male: yes | 750 | Phase 3 | United States;Israel;Italy;France;Hungary;Mexico;Canada;Argentina;Brazil;Poland;South Africa;Germany;Netherlands;New Zealand;Korea, Republic of | ||
| 175 | EUCTR2018-001405-87-CZ (EUCTR) | 23/01/2019 | 06/12/2018 | A clinical study to test how effective and safe GLPG1690 is for subjects with idiopathic pulmonary fibrosis (IPF) when used together with standard medical treatment | A Phase 3, randomized, double-blind, parallel-group, placebo-controlled, multi-center study to evaluate the efficacy and safety of two doses of GLPG1690 in addition to local standard of care for minimum 52 weeks in subjects with idiopathic pulmonary fibrosis. | Idiopatic pulmonary fibrosis MedDRA version: 20.0;Level: SOC;Classification code 10038738;Term: Respiratory, thoracic and mediastinal disorders;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: GLPG1690 Product Code: G451990 INN or Proposed INN: ziritaxestat Other descriptive name: GLPG1690 Product Name: GLPG1690 Product Code: G451990 INN or Proposed INN: ziritaxestat Other descriptive name: GLPG1690 | Galapagos NV | NULL | Not Recruiting | Female: yes Male: yes | 750 | Phase 3 | United States;Taiwan;Greece;Finland;Spain;Turkey;Chile;United Kingdom;Czech Republic;Belgium;Brazil;Australia;Denmark;Peru;Germany | ||
| 176 | EUCTR2018-001406-29-HU (EUCTR) | 17/01/2019 | 04/12/2018 | A clinical study to test how effective and safe GLPG1690 is for subjects with idiopathic pulmonary fibrosis (IPF) when used together with standard medical treatment | A Phase 3, randomized, double-blind, parallel-group, placebo-controlled, multi-center study to evaluate the efficacy and safety of two doses of GLPG1690 in addition to local standard of care for minimum 52 weeks in subjects with idiopathic pulmonary fibrosis. | Idiopatic pulmonary fibrosis MedDRA version: 20.0;Level: SOC;Classification code 10038738;Term: Respiratory, thoracic and mediastinal disorders;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: GLPG1690 Product Code: G451990 INN or Proposed INN: ziritaxestat Other descriptive name: GLPG1690 Product Name: GLPG1690 Product Code: G451990 INN or Proposed INN: ziritaxestat Other descriptive name: GLPG1690 | Galapagos NV | NULL | Not Recruiting | Female: yes Male: yes | 750 | Phase 3 | United States;Israel;Italy;France;Hungary;Mexico;Canada;Argentina;Poland;Brazil;South Africa;Germany;Netherlands;Japan;New Zealand;Korea, Republic of | ||
| 177 | EUCTR2017-004302-18-HR (EUCTR) | 14/01/2019 | 16/05/2019 | A clinical study to test how effective and safe GLPG1205 is for patients with Idiopathic Pulmonary Fibrosis (IPF) | A Phase II randomized, double-blind, placebo-controlled, 26-week study to evaluate the efficacy, safety and tolerability of GLPG1205 in subjects with idiopathic pulmonary fibrosis. | Idiopathic pulmonary fibrosis MedDRA version: 20.0;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: GLPG1205 Product Code: G321605 INN or Proposed INN: NA Other descriptive name: GLPG1205 | Galapagos NV | NULL | Not Recruiting | Female: yes Male: yes | 60 | Phase 2 | France;Egypt;Slovakia;Finland;Ukraine;Oman;Romania;Croatia;Bulgaria;Sweden | ||
| 178 | EUCTR2018-001406-29-PL (EUCTR) | 21/12/2018 | 17/12/2018 | A clinical study to test how effective and safe GLPG1690 is for subjects with idiopathic pulmonary fibrosis (IPF) when used together with standard medical treatment | A Phase 3, randomized, double-blind, parallel-group, placebo-controlled, multi-center study to evaluate the efficacy and safety of two doses of GLPG1690 in addition to local standard of care for minimum 52 weeks in subjects with idiopathic pulmonary fibrosis. | Idiopatic pulmonary fibrosis MedDRA version: 20.0;Level: SOC;Classification code 10038738;Term: Respiratory, thoracic and mediastinal disorders;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: GLPG1690 Product Code: G451990 INN or Proposed INN: ziritaxestat Other descriptive name: GLPG1690 Product Name: GLPG1690 Product Code: G451990 INN or Proposed INN: ziritaxestat Other descriptive name: GLPG1690 | Galapagos NV | NULL | Not Recruiting | Female: yes Male: yes | 750 | Phase 3 | United States;Israel;Italy;France;Hungary;Mexico;Canada;Argentina;Poland;Brazil;South Africa;Netherlands;Germany;Japan;New Zealand;Korea, Republic of | ||
| 179 | EUCTR2018-001405-87-DK (EUCTR) | 20/12/2018 | 22/11/2018 | A clinical study to test how effective and safe GLPG1690 is for subjects with idiopathic pulmonary fibrosis (IPF) when used together with standard medical treatment | A Phase 3, randomized, double-blind, parallel-group, placebo-controlled, multi-center study to evaluate the efficacy and safety of two doses of GLPG1690 in addition to local standard of care for minimum 52 weeks in subjects with idiopathic pulmonary fibrosis. | Idiopatic pulmonary fibrosis MedDRA version: 20.0;Level: SOC;Classification code 10038738;Term: Respiratory, thoracic and mediastinal disorders;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: GLPG1690 Product Code: G451990 INN or Proposed INN: ziritaxestat Other descriptive name: GLPG1690 Product Name: GLPG1690 Product Code: G451990 INN or Proposed INN: ziritaxestat Other descriptive name: GLPG1690 | Galapagos NV | NULL | Not Recruiting | Female: yes Male: yes | 750 | Phase 3 | United States;Taiwan;Greece;Finland;Spain;Turkey;Chile;United Kingdom;Czech Republic;Belgium;Brazil;Denmark;Australia;Peru;Germany | ||
| 180 | EUCTR2018-001406-29-IT (EUCTR) | 13/12/2018 | 20/01/2021 | A clinical study to test how effective and safe GLPG1690 is for subjects with idiopathic pulmonary fibrosis (IPF) when used together with standard medical treatment | A Phase 3, randomized, double-blind, parallel-group, placebo-controlled, multi-center study to evaluate the efficacy and safety of two doses of GLPG1690 in addition to local standard of care for minimum 52 weeks in subjects with idiopathic pulmonary fibrosis - - | Idiopatic pulmonary fibrosis MedDRA version: 20.0;Level: SOC;Classification code 10038738;Term: Respiratory, thoracic and mediastinal disorders;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: GLPG1690 Product Code: [G451990] Product Name: GLPG1690 Product Code: [G451990] | GALAPAGOS NV | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 750 | Phase 3 | United States;Israel;Italy;France;Hungary;Mexico;Canada;Argentina;Poland;Brazil;South Africa;Netherlands;Germany;New Zealand;Korea, Republic of | ||
| 181 | EUCTR2018-001405-87-ES (EUCTR) | 12/12/2018 | 18/01/2019 | A clinical study to test how effective and safe GLPG1690 is for subjects with idiopathic pulmonary fibrosis (IPF) when used together with standard medical treatment | A Phase 3, randomized, double-blind, parallel-group, placebo-controlled, multi-center study to evaluate the efficacy and safety of two doses of GLPG1690 in addition to local standard of care for minimum 52 weeks in subjects with idiopathic pulmonary fibrosis. | Idiopatic pulmonary fibrosis MedDRA version: 20.0;Level: SOC;Classification code 10038738;Term: Respiratory, thoracic and mediastinal disorders;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: GLPG1690 Product Code: G451990 INN or Proposed INN: Not applicable Other descriptive name: GLPG1690 Product Name: GLPG1690 Product Code: G451990 INN or Proposed INN: Not applicable Other descriptive name: GLPG1690 | Galapagos NV | NULL | Not Recruiting | Female: yes Male: yes | 750 | Phase 3 | United States;Taiwan;Greece;Finland;Spain;Turkey;Chile;United Kingdom;Czech Republic;Belgium;Australia;Denmark;Peru;Germany | ||
| 182 | EUCTR2017-004302-18-SE (EUCTR) | 03/12/2018 | 01/08/2018 | A clinical study to test how effective and safe GLPG1205 is for patients with Idiopathic Pulmonary Fibrosis (IPF) | A Phase II randomized, double-blind, placebo-controlled, 26-week study to evaluate the efficacy, safety and tolerability of GLPG1205 in subjects with idiopathic pulmonary fibrosis. | Idiopathic pulmonary fibrosis MedDRA version: 21.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: GLPG1205 Product Code: G321605 INN or Proposed INN: NA Other descriptive name: GLPG1205 | Galapagos NV | NULL | Not Recruiting | Female: yes Male: yes | 60 | Phase 2 | France;Egypt;Slovakia;Finland;Ukraine;Oman;Romania;Croatia;Bulgaria;Sweden | ||
| 183 | NCT03711162 (ClinicalTrials.gov) | November 28, 2018 | 15/10/2018 | A Clinical Study to Test How Effective and Safe GLPG1690 is for Subjects With Idiopathic Pulmonary Fibrosis (IPF) When Used Together With Standard of Care | A Phase 3, Randomized, Double-blind, Parallel-group, Placebo-controlled Multicenter Study to Evaluate the Efficacy and Safety of Two Doses of GLPG1690 in Addition to Local Standard of Care for Minimum 52 Weeks in Subjects With Idiopathic Pulmonary Fibrosis | Idiopathic Pulmonary Fibrosis | Drug: GLPG1690;Drug: Placebo | Galapagos NV | NULL | Terminated | 40 Years | N/A | All | 526 | Phase 3 | United States;Australia;Belgium;Brazil;Chile;Czechia;Denmark;Germany;Greece;Japan;Peru;Spain;Taiwan;Turkey;United Kingdom |
| 184 | NCT03727802 (ClinicalTrials.gov) | November 28, 2018 | 24/10/2018 | Safety, Tolerability, and Pharmacokinetic Study of TRK-250 for Patients With Idiopathic Pulmonary Fibrosis | TRK-250 - A Phase I, Double-Blind, Placebo-Controlled, Single and Multiple Inhaled Dose, Safety, Tolerability, and Pharmacokinetic Study of TRK-250 in Subjects With Idiopathic Pulmonary Fibrosis | Idiopathic Pulmonary Fibrosis | Drug: TRK-250;Drug: Placebo | Toray Industries, Inc | NULL | Completed | 40 Years | 80 Years | All | 34 | Phase 1 | United States |
| 185 | EUCTR2017-004919-39-DE (EUCTR) | 20/11/2018 | 16/07/2018 | A study to test the safety, tolerability, biological activity, and pharmacokinetics of the drug ND-L02-s0201 compared with a placebo in patients with Idiopathic Pulmonary Fibrosis (IPF) | A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, Biological Activity, and PK of ND-L02-s0201 in Subjects with Idiopathic Pulmonary Fibrosis (IPF) | Idiopathic Pulmonary Fibrosis (IPF) MedDRA version: 21.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: ND-L02-s0201 for injection INN or Proposed INN: TBC | Nitto Denko Corporation | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 120 | Phase 2 | United States;Germany;United Kingdom;Japan | ||
| 186 | EUCTR2017-003158-18-DK (EUCTR) | 15/11/2018 | 16/05/2018 | Evaluating the Efficacy and Safety of BG00011 in Participants with Idiopathic Pulmonary Fibrosis | A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of BG00011 in Patients With Idiopathic Pulmonary Fibrosis | mild to moderate Idiopathic Pulmonary Fibrosis MedDRA version: 20.0;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: humanized anti-alpha v beta 6 mAb Product Code: BG00011 INN or Proposed INN: Not yet assigned Other descriptive name: BG00011 | Biogen Idec Research Limited | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 290 | Phase 2 | United States;Greece;Spain;Turkey;Russian Federation;Israel;Italy;United Kingdom;France;Czech Republic;Canada;Argentina;Poland;Belgium;Denmark;Australia;Netherlands;Germany;Korea, Republic of | ||
| 187 | EUCTR2018-002632-24-FR (EUCTR) | 13/11/2018 | 20/07/2018 | to evaluate a triple therapy: plasma exchange, rituximab, intravenous immunoglobulin (IVIg) and corticosteroid administration compared to standard corticosteroid therapy in patients for severe acute exacerbation of idiopathic pulmonary | Therapeutic plasma exchange, rituximab and intravenous immunoglobulins (IVIg) for severe acute exacerbation of idiopathic pulmonary fibrosis admitted in ICU: an open, randomized, controlled trial - EXCHANGE-IFP | severe acute exacerbation of idiopathic pulmonary fibrosis;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Trade Name: RIXATHON 500 mg Trade Name: PRIVIGEN 100mg/ml | ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP) | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 40 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | France | ||
| 188 | NCT03733444 (ClinicalTrials.gov) | November 5, 2018 | 5/11/2018 | A Clinical Study to Test How Effective and Safe GLPG1690 is for Subjects With Idiopathic Pulmonary Fibrosis (IPF) When Used Together With Standard of Care | A Phase 3, Randomized, Double-blind, Parallel-group, Placebo-controlled, Multi-center Study to Evaluate the Efficacy and Safety of Two Doses of GLPG1690 in Addition to Local Standard of Care for Minimum 52 Weeks in Subjects With Idiopathic Pulmonary Fibrosis | Idiopathic Pulmonary Fibrosis | Drug: GLPG1690;Drug: Placebo | Galapagos NV | NULL | Terminated | 40 Years | N/A | All | 781 | Phase 3 | United States;Argentina;Canada;France;Germany;Hungary;Israel;Italy;Japan;Korea, Republic of;Mexico;Netherlands;New Zealand;Poland;South Africa |
| 189 | EUCTR2017-004302-18-BG (EUCTR) | 22/10/2018 | 06/08/2018 | A clinical study to test how effective and safe GLPG1205 is for patients with Idiopathic Pulmonary Fibrosis (IPF) | A Phase II randomized, double-blind, placebo-controlled, 26-week study to evaluate the efficacy, safety and tolerability of GLPG1205 in subjects with idiopathic pulmonary fibrosis. | Idiopathic pulmonary fibrosis MedDRA version: 21.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: GLPG1205 Product Code: G321605 INN or Proposed INN: NA Other descriptive name: GLPG1205 | Galapagos NV | NULL | Not Recruiting | Female: yes Male: yes | 60 | Phase 2 | France;Egypt;Slovakia;Finland;Ukraine;Oman;Romania;Croatia;Bulgaria;Sweden | ||
| 190 | EUCTR2017-004302-18-FR (EUCTR) | 16/10/2018 | 03/08/2018 | A clinical study to test how effective and safe GLPG1205 is for patients with Idiopathic Pulmonary Fibrosis (IPF) | A Phase II randomized, double-blind, placebo-controlled, 26-week study to evaluate the efficacy, safety and tolerability of GLPG1205 in subjects with idiopathic pulmonary fibrosis. | Idiopathic pulmonary fibrosis MedDRA version: 20.0;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: GLPG1205 Product Code: G321605 INN or Proposed INN: NA Other descriptive name: GLPG1205 | Galapagos NV | NULL | Not Recruiting | Female: yes Male: yes | 60 | Phase 2 | Egypt;France;Slovakia;Finland;Ukraine;Oman;Lebanon;Romania;Croatia;Bulgaria;Sweden | ||
| 191 | EUCTR2017-003158-18-NL (EUCTR) | 10/10/2018 | 24/05/2018 | Evaluating the Efficacy and Safety of BG00011 in Participants with Idiopathic Pulmonary Fibrosis | A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of BG00011 in Patients With Idiopathic Pulmonary Fibrosis - SPIRIT | mild to moderate Idiopathic Pulmonary Fibrosis MedDRA version: 20.0;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: humanized anti-alpha v beta 6 mAb Product Code: BG00011 INN or Proposed INN: Not yet assigned Other descriptive name: BG00011 | Biogen Idec Research Limited | NULL | Not Recruiting | Female: yes Male: yes | 290 | Phase 2 | United States;Greece;Spain;Turkey;Russian Federation;Israel;United Kingdom;Italy;France;Czech Republic;Canada;Argentina;Poland;Belgium;Australia;Denmark;Netherlands;Germany;Korea, Republic of | ||
| 192 | NCT03725852 (ClinicalTrials.gov) | September 27, 2018 | 8/6/2018 | A Clinical Study to Test How Effective and Safe GLPG1205 is for Patients With Idiopathic Pulmonary Fibrosis (IPF) | A Phase II Randomized, Double-blind, Placebo-controlled, 26-week Study to Evaluate the Efficacy, Safety and Tolerability of GLPG1205 in Subjects With Idiopathic Pulmonary Fibrosis | Idiopathic Pulmonary Fibrosis | Drug: GLPG1205;Drug: Placebo | Galapagos NV | NULL | Completed | 40 Years | N/A | All | 69 | Phase 2 | Bulgaria;Croatia;Finland;France;Oman;Romania;Slovakia;Sweden;Ukraine |
| 193 | EUCTR2017-003158-18-BE (EUCTR) | 26/09/2018 | 29/05/2018 | Evaluating the Efficacy and Safety of BG00011 in Participants with Idiopathic Pulmonary Fibrosis | A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of BG00011 in Patients With Idiopathic Pulmonary Fibrosis | mild to moderate Idiopathic Pulmonary Fibrosis MedDRA version: 20.0;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: humanized anti-alpha v beta 6 mAb Product Code: BG00011 INN or Proposed INN: Not yet assigned Other descriptive name: BG00011 | Biogen Idec Research Limited | NULL | Not Recruiting | Female: yes Male: yes | 290 | Phase 2 | United States;Greece;Spain;Turkey;Russian Federation;Israel;United Kingdom;Italy;France;Czech Republic;Canada;Argentina;Poland;Belgium;Australia;Denmark;Germany;Netherlands;Korea, Republic of | ||
| 194 | NCT03573505 (ClinicalTrials.gov) | September 24, 2018 | 19/6/2018 | An Efficacy and Safety Study of BG00011 in Participants With Idiopathic Pulmonary Fibrosis | A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of BG00011 in Patients With Idiopathic Pulmonary Fibrosis | Idiopathic Pulmonary Fibrosis | Drug: BG00011;Drug: Placebo | Biogen | NULL | Terminated | 40 Years | N/A | All | 109 | Phase 2 | United States;Argentina;Australia;Belgium;Chile;Czechia;Denmark;France;Greece;Israel;Italy;Korea, Republic of;Netherlands;Poland;Russian Federation;Spain;United Kingdom |
| 195 | EUCTR2017-003158-18-GR (EUCTR) | 21/09/2018 | 25/05/2018 | Evaluating the Efficacy and Safety of BG00011 in Participants with Idiopathic Pulmonary Fibrosis | A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of BG00011 in Patients With Idiopathic Pulmonary Fibrosis | mild to moderate Idiopathic Pulmonary Fibrosis MedDRA version: 20.0;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: humanized anti-alpha v beta 6 mAb Product Code: BG00011 INN or Proposed INN: Not yet assigned Other descriptive name: BG00011 | Biogen Idec Research Limited | NULL | Not Recruiting | Female: yes Male: yes | 290 | Phase 2 | United States;Greece;Spain;Turkey;Russian Federation;Israel;Italy;United Kingdom;France;Czech Republic;Canada;Argentina;Poland;Belgium;Australia;Denmark;Netherlands;Germany;Korea, Republic of | ||
| 196 | EUCTR2017-002667-17-IT (EUCTR) | 20/09/2018 | 13/02/2018 | Study of pharmacodynamics, pharmacokinetics, safety and tolerability of VAY736 in patients with idiopathic pulmonary fibrosis | A subject-, investigator-, and sponsor-blinded, randomized, placebo-controlled, multicenter study to investigate efficacy, safety, and tolerability of VAY736 in patients with idiopathic pulmonary fibrosis - Study of pharmacodynamics,pharmacokinetics, safety and tolerability of VAY736 in patients with idiop | Idiopathic pulmonary fibrosis MedDRA version: 20.0;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Code: VAY736 INN or Proposed INN: not established Other descriptive name: VAY736 | Novartis Pharma AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 84 | Phase 2 | United States;France;Canada;Ireland;Germany;United Kingdom;Italy | ||
| 197 | EUCTR2017-003158-18-GB (EUCTR) | 18/09/2018 | 10/05/2018 | Evaluating the Efficacy and Safety of BG00011 in Participants with Idiopathic Pulmonary Fibrosis | A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of BG00011 in Patients With Idiopathic Pulmonary Fibrosis - 203PF203 | mild to moderate Idiopathic Pulmonary Fibrosis MedDRA version: 20.0;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders ;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: humanized anti-alpha v beta 6 mAb Product Code: BG00011 INN or Proposed INN: Not yet assigned Other descriptive name: BG00011 | Biogen Idec Research Limited | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 290 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | United States;Greece;Spain;Turkey;Russian Federation;Israel;Italy;United Kingdom;France;Czech Republic;Canada;Argentina;Poland;Belgium;Australia;Denmark;Netherlands;Germany;Korea, Republic of | ||
| 198 | EUCTR2017-003158-18-CZ (EUCTR) | 12/09/2018 | 09/05/2018 | Evaluating the Efficacy and Safety of BG00011 in Participants with Idiopathic Pulmonary Fibrosis | A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of BG00011 in Patients With Idiopathic Pulmonary Fibrosis | mild to moderate Idiopathic Pulmonary Fibrosis MedDRA version: 20.0;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: humanized anti-alpha v beta 6 mAb Product Code: BG00011 INN or Proposed INN: Not yet assigned Other descriptive name: BG00011 | Biogen Idec Research Limited | NULL | Not Recruiting | Female: yes Male: yes | 290 | Phase 2 | United States;Greece;Spain;Turkey;Russian Federation;Israel;Italy;United Kingdom;France;Czech Republic;Canada;Argentina;Poland;Belgium;Australia;Denmark;Netherlands;Germany;Korea, Republic of | ||
| 199 | EUCTR2017-003158-18-IT (EUCTR) | 03/09/2018 | 05/11/2020 | Evaluating the Efficacy and Safety of BG00011 in Participants with Idiopathic Pulmonary Fibrosis | A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of BG00011 in Patients With Idiopathic Pulmonary Fibrosis - Evaluating the Efficacy and Safety of BG00011 in Participants with Idiopathic Pulmonary Fibrosis | mild to moderate Idiopathic Pulmonary Fibrosis MedDRA version: 21.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Trade Name: NA Product Name: humanized anti-alpha v beta 6 mAb Product Code: [BG00011] INN or Proposed INN: Not yet assigned | BIOGEN IDEC RESEARCH LIMITED | NULL | Not Recruiting | Female: yes Male: yes | 290 | Phase 2 | United States;Czechia;Greece;Spain;Turkey;Austria;Russian Federation;Israel;United Kingdom;Italy;France;Czech Republic;Canada;Argentina;Poland;Belgium;Denmark;Germany;Netherlands;Korea, Republic of | ||
| 200 | EUCTR2017-003158-18-ES (EUCTR) | 27/07/2018 | 05/06/2018 | Evaluating the Efficacy and Safety of BG00011 in Participants with Idiopathic Pulmonary Fibrosis | A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of BG00011 in Patients With Idiopathic Pulmonary Fibrosis | mild to moderate Idiopathic Pulmonary Fibrosis MedDRA version: 20.0;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: humanized anti-alpha v beta 6 mAb Product Code: BG00011 INN or Proposed INN: Not yet assigned Other descriptive name: BG00011 | Biogen Idec Research Limited | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 290 | Phase 2 | United States;Greece;Spain;Turkey;Russian Federation;Israel;Italy;United Kingdom;France;Czech Republic;Canada;Argentina;Poland;Belgium;Australia;Denmark;Netherlands;Germany;Korea, Republic of | ||
| 201 | NCT03619616 (ClinicalTrials.gov) | July 16, 2018 | 23/7/2018 | Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Single Ascending Dose of ZSP1603 in Healthy Adults | A Phase 1 Randomized,Double-Blind,Parallel-Group, Placebo-Controlled Study to Evaluate the Safety, Tolerability and Pharmacokinetics of ZSP1603 in Chinese Healthy Subjects | Idiopathic Pulmonary Fibrosis(IPF);Solid Tumor | Drug: ZSP1603 7.5 mg;Drug: ZSP1603 12.5 mg;Drug: Placebo 12.5mg;Drug: ZSP1603 25 mg;Drug: Placebo 25mg;Drug: ZSP1603 50 mg;Drug: Placebo 50mg | Guangdong Zhongsheng Pharmaceutical Co., Ltd. | NULL | Completed | 18 Years | 50 Years | All | 40 | Phase 1 | China |
| 202 | EUCTR2017-004923-63-GB (EUCTR) | 10/07/2018 | 20/12/2017 | A study to test the safety, tolerability, and the effects of C21 in patients with Idiopathic Pulmonary Fibrosis (IPF) | A phase 2, multi-center, randomized, double-blind, placebo-controlled, parallel-group study to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of C21 in patients with Idiopathic Pulmonary Fibrosis (IPF) | Idiopathic Pulmonary Fibrosis (IPF) MedDRA version: 20.0;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders ;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: C21 INN or Proposed INN: PD00377 Na-salt Other descriptive name: COMPOUND 21 | Vicore Pharma AB | NULL | Not Recruiting | Female: yes Male: yes | 30 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | Serbia;Poland;Bulgaria;United Kingdom | ||
| 203 | NCT03538301 (ClinicalTrials.gov) | June 18, 2018 | 2/5/2018 | JUNIPER: A Phase 2 Study to Evaluate the Safety, Biological Activity, and PK of ND-L02-s0201 in Subjects With IPF | A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, Biological Activity, and PK of ND-L02-s0201 in Subjects With Idiopathic Pulmonary Fibrosis (IPF) | Idiopathic Pulmonary Fibrosis | Drug: ND-L02-s0201;Other: Other: Placebo | Nitto Denko Corporation | NULL | Completed | 40 Years | 80 Years | All | 123 | Phase 2 | United States;Germany;Japan;United Kingdom |
| 204 | EUCTR2017-004302-18-SK (EUCTR) | 18/06/2018 | 04/05/2018 | A clinical study to test how effective and safe GLPG1205 is for patients with Idiopathic Pulmonary Fibrosis (IPF) | A Phase II randomized, double-blind, placebo-controlled, 26-week study to evaluate the efficacy, safety and tolerability of GLPG1205 in subjects with idiopathic pulmonary fibrosis. | Idiopathic pulmonary fibrosis MedDRA version: 20.0;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: GLPG1205 Product Code: G321605 INN or Proposed INN: NA Other descriptive name: GLPG1205 | Galapagos NV | NULL | Not Recruiting | Female: yes Male: yes | 60 | Phase 2 | France;Egypt;Slovakia;Finland;Ukraine;Oman;Romania;Croatia;Bulgaria;Sweden | ||
| 205 | EUCTR2017-002667-17-FR (EUCTR) | 06/06/2018 | 20/02/2018 | Study of pharmacodynamics, pharmacokinetics, safety and tolerability of VAY736 in patients with idiopathic pulmonary fibrosis | A subject-, investigator-, and sponsor-blinded, randomized, placebo-controlled, multicenter study to investigate efficacy, safety, and tolerability of VAY736 in patients with idiopathic pulmonary fibrosis | Idiopathic pulmonary fibrosis MedDRA version: 20.0;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders ;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Code: VAY736 INN or Proposed INN: not established Other descriptive name: VAY736 | Novartis Pharma AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 84 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | United States;France;Canada;Ireland;Germany;Italy;United Kingdom | ||
| 206 | EUCTR2017-002667-17-DE (EUCTR) | 04/06/2018 | 23/01/2018 | Study of pharmacodynamics, pharmacokinetics, safety and tolerability of VAY736 in patients with idiopathic pulmonary fibrosis | A subject-, investigator-, and sponsor-blinded, randomized, placebo-controlled, multicenter study to investigate efficacy, safety, and tolerability of VAY736 in patients with idiopathic pulmonary fibrosis | Idiopathic pulmonary fibrosis MedDRA version: 21.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Code: VAY736 INN or Proposed INN: not established Other descriptive name: VAY736 | Novartis Pharma AG | NULL | Not Recruiting | Female: yes Male: yes | 58 | Phase 2 | United States;France;Canada;Ireland;Germany;United Kingdom;Italy | ||
| 207 | EUCTR2016-003827-45-GR (EUCTR) | 29/05/2018 | 16/05/2018 | AN OPEN LABEL PHASE IV, MULTICENTER, INTERNATIONAL, INTERVENTIONAL STUDY TO EVALUATE THE EFFECT OF DIET ON GASTROINTESTINAL ADVERSE EVENTS IN PATIENTS WITH IPF TREATED WITH PIRFENIDONE | AN OPEN LABEL PHASE IV, MULTICENTER, INTERNATIONAL, INTERVENTIONAL STUDY TO EVALUATE THE EFFECT OF DIET ON GASTROINTESTINAL ADVERSE EVENTS IN PATIENTS WITH IPF TREATED WITH PIRFENIDONE - MADIET | Idiopathic Pulmonary Fibrosis MedDRA version: 20.0;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Trade Name: ESBRIET Product Name: ESBRIET INN or Proposed INN: PIRFENIDONE Other descriptive name: ESBRIET Trade Name: ESBRIET Product Name: ESBRIET INN or Proposed INN: PIRFENIDONE Other descriptive name: ESBRIET Trade Name: ESBRIET Product Name: ESBRIET INN or Proposed INN: PIRFENIDONE Other descriptive name: ESBRIET | CIBERES - Instituto Carlos III | Institut d'Investigació Biomédica de Bellvitge (IDIBELL) | Not Recruiting | Female: yes Male: yes | 90 | Phase 4 | Greece;Spain;United Kingdom | ||
| 208 | EUCTR2017-002667-17-GB (EUCTR) | 18/05/2018 | 08/11/2017 | Study of pharmacodynamics, pharmacokinetics, safety and tolerability of VAY736 in patients with idiopathic pulmonary fibrosis | A subject-, investigator-, and sponsor-blinded, randomized, placebo-controlled, multicenter study to investigate efficacy, safety, and tolerability of VAY736 in patients with idiopathic pulmonary fibrosis | Idiopathic pulmonary fibrosis MedDRA version: 21.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Code: VAY736 INN or Proposed INN: not established Other descriptive name: VAY736 | Novartis Pharma AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 58 | Phase 2 | United States;France;Canada;Ireland;Germany;Italy;United Kingdom | ||
| 209 | EUCTR2016-003827-45-GB (EUCTR) | 15/05/2018 | 01/02/2018 | AN OPEN LABEL PHASE IV, MULTICENTER, INTERNATIONAL, INTERVENTIONAL STUDY TO EVALUATE THE EFFECT OF DIET ON GASTROINTESTINAL ADVERSE EVENTS IN PATIENTS WITH IPF TREATED WITH PIRFENIDONE | AN OPEN LABEL PHASE IV, MULTICENTER, INTERNATIONAL, INTERVENTIONAL STUDY TO EVALUATE THE EFFECT OF DIET ON GASTROINTESTINAL ADVERSE EVENTS IN PATIENTS WITH IPF TREATED WITH PIRFENIDONE - MADIET (version 1.6) | Idiopathic Pulmonary Fibrosis MedDRA version: 20.0;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders ;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Trade Name: ESBRIET Product Name: ESBRIET INN or Proposed INN: PIRFENIDONE Other descriptive name: ESBRIET Trade Name: ESBRIET Product Name: ESBRIET INN or Proposed INN: PIRFENIDONE Other descriptive name: ESBRIET Trade Name: ESBRIET Product Name: ESBRIET INN or Proposed INN: PIRFENIDONE Other descriptive name: ESBRIET | CIBER - Instituto Carlos III | Institut d'Investigació Biomédica de Bellvitge (IDIBELL) | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 90 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yes | Greece;Spain;United Kingdom | ||
| 210 | NCT03502902 (ClinicalTrials.gov) | April 26, 2018 | 10/4/2018 | The Safety, Tolerability and Pharmacokinetic Study of HEC68498 in Healthy Male and Female Subjects | A Phase I, Double-blind, Placebo-controlled, Single Oral Dose, Safety, Tolerability, and Pharmacokinetic Study, Incorporating an Evaluation of the Effect of Food on the Pharmacokinetics of HEC68498 in Healthy Male and Female Subjects | Idiopathic Pulmonary Fibrosis | Drug: HEC 68498;Drug: Placebo | Sunshine Lake Pharma Co., Ltd. | Covance | Completed | 18 Years | 60 Years | All | 55 | Phase 1 | United States |
| 211 | NCT03500731 (ClinicalTrials.gov) | April 19, 2018 | 30/3/2018 | Lung and Bone Marrow Transplantation for Lung and Bone Marrow Failure | Lung Transplant in Tandem With Bone Marrow Transplant for Combined Lung and Bone Marrow Failure | Idiopathic Pulmonary Fibrosis;Emphysema or COPD | Biological: CD3/CD19 negative hematopoietic stem cells;Drug: Rituximab;Drug: Alemtuzumab;Drug: Fludarabine;Drug: Thiotepa;Drug: G-CSF;Drug: Hydroxyurea | Paul Szabolcs | NULL | Recruiting | 18 Years | 60 Years | All | 8 | Phase 1/Phase 2 | United States |
| 212 | EUCTR2017-002667-17-IE (EUCTR) | 06/04/2018 | 08/11/2017 | Study of pharmacodynamics, pharmacokinetics, safety and tolerability of VAY736 in patients with idiopathic pulmonary fibrosis | A subject-, investigator-, and sponsor-blinded, randomized, placebo-controlled, multicenter study to investigate efficacy, safety, and tolerability of VAY736 in patients with idiopathic pulmonary fibrosis | Idiopathic pulmonary fibrosis MedDRA version: 21.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Code: VAY736 INN or Proposed INN: not established Other descriptive name: VAY736 | Novartis Pharma AG | NULL | Not Recruiting | Female: yes Male: yes | 58 | Phase 2 | United States;France;Canada;Ireland;Germany;United Kingdom;Italy | ||
| 213 | NCT03422068 (ClinicalTrials.gov) | March 16, 2018 | 22/1/2018 | This Study Tests Different Doses of BI 1015550 in Patients With Idiopathic Pulmonary Fibrosis (IPF). The Study Tests How BI 1015550 is Taken up by the Body and How Well it is Tolerated. | Safety, Tolerability, and Pharmacokinetics of Multiple Rising Oral Doses of BI 1015550 in Patients With Idiopathic Pulmonary Fibrosis (IPF) on no Background Anti-fibrotic Therapy. | Idiopathic Pulmonary Fibrosis | Drug: BI 1015550;Drug: Placebo | Boehringer Ingelheim | NULL | Completed | 40 Years | N/A | All | 15 | Phase 1 | Belgium;Denmark;Finland;Germany;Italy;Netherlands;Spain;United Kingdom;France |
| 214 | NCT02871401 (ClinicalTrials.gov) | January 3, 2018 | 15/8/2016 | A Pilot Trial of Herpesvirus Treatment in Idiopathic Pulmonary Fibrosis (IPF) | A Phase One-B (1B) Pilot Trial of Herpesvirus Treatment in Idiopathic Pulmonary Fibrosis (IPF) | Idiopathic Pulmonary Fibrosis | Drug: Valganciclovir;Drug: Placebo | Vanderbilt University Medical Center | Genentech, Inc. | Completed | 21 Years | 80 Years | All | 31 | Phase 1 | United States |
| 215 | NCT03287414 (ClinicalTrials.gov) | December 20, 2017 | 12/9/2017 | Study of Pharmacodynamics, Pharmacokinetics, Safety and Tolerability of VAY736 in Patients With Idiopathic Pulmonary Fibrosis | A Subject-, Investigator-, and Sponsor-blinded, Randomized, Placebo-controlled, Multicenter Study to Investigate Efficacy, Safety, and Tolerability of VAY736 in Patients With Idiopathic Pulmonary Fibrosis | Idiopathic Pulmonary Fibrosis | Drug: VAY736;Drug: Placebo;Drug: Standard of Care (SoC) | Novartis Pharmaceuticals | NULL | Completed | 40 Years | 80 Years | All | 30 | Phase 2 | United States;Canada;Germany;Ireland;Italy;United Kingdom;France |
| 216 | NCT03928847 (ClinicalTrials.gov) | December 1, 2017 | 18/4/2019 | Fibroblast Specific Inhibition of LOXL2 and TGFbeta1 Signaling in Patients With Pulmonary Fibrosis. | Fibroblast Specific Inhibition of LOXL2 and TGFbeta1 Signaling in Patients With Pulmonary Fibrosis. | Idiopathic Pulmonary Fibrosis | Drug: Epigallocatechin-3-gallate (EGCG) | Hal Chapman | National Heart, Lung, and Blood Institute (NHLBI) | Completed | 40 Years | 70 Years | All | 35 | Early Phase 1 | United States |
| 217 | NCT03183570 (ClinicalTrials.gov) | November 8, 2017 | 8/5/2017 | Detection of Integrin avb6 in IPF, PSC, and COVID19 Using PET/CT | Detection of Integrin avb6 in Idiopathic Pulmonary Fibrosis, Primary Sclerosing Cholangitis, and Coronavirus Disease 2019 With [18F]FP-R01-MG-F2 With PET/CT | Idiopathic Pulmonary Fibrosis;Primary Sclerosing Cholangitis;Covid19 Pneumonia | Drug: [18F]FP-R01-MG-F2 | Stanford University | Pliant Therapeutics, Inc. | Recruiting | 18 Years | N/A | All | 30 | Early Phase 1 | United States |
| 218 | NCT03281200 (ClinicalTrials.gov) | October 24, 2017 | 11/9/2017 | Chart Review Study to Describe the Clinical Profile of Idiopathic Pulmonary Fibrosis (IPF) Patients Treated With Nintedanib (OFEV®) in Real-world Practice in Spain | A Multicentre, Retrospective Chart Review Study to Describe the Clinical Profile of Idiopathic Pulmonary Fibrosis (IPF) Patients Treated With Nintedanib (OFEV®) in Real-world Practice in Spain. | Idiopathic Pulmonary Fibrosis | Drug: L - Antineoplastic and immunomodulating agents;Drug: L01 - Antineoplastic agents;Drug: L01X - Other antineoplastic agents;Drug: L01XE - Protein kinase inhibitors;Drug: L01XE31 - Nintedanib | Boehringer Ingelheim | NULL | Completed | 18 Years | N/A | All | 172 | Spain | |
| 219 | NCT03208933 (ClinicalTrials.gov) | October 23, 2017 | 26/6/2017 | Open-label Study to Assess the Effectiveness of Pirfenidone in Participants With Idiopathic Pulmonary Fibrosis (IPF). | Local Open-label Multicenter Study to Assess the Effectiveness of Pirfenidone in Patients With Idiopathic Pulmonary Fibrosis in Russian Clinical Practice | Idiopathic Pulmonary Fibrosis | Drug: Pirfenidone | Hoffmann-La Roche | NULL | Completed | 40 Years | 80 Years | All | 60 | Phase 3 | Russian Federation |
| 220 | JPRN-UMIN000029411 | 2017/10/15 | 15/10/2017 | Phase III study of perioperative pirfenidone therapy in patients with non-small-cell lung cancer combined with idiopathic pulmonary fibrosis (IPF) for confirming the effect for prevention of postoperative acute exacerbation | Phase III study of perioperative pirfenidone therapy in patients with non-small-cell lung cancer combined with idiopathic pulmonary fibrosis (IPF) for confirming the effect for prevention of postoperative acute exacerbation - PIII-PEOPLE study | non-small-cell lung cancer combined with idiopathic pulmonary fibrosis | Oral pirfenidone (600mg) is administrated for 14days after registration, and oral pirfenidone (1200mg) for more 14days before surgery. It's recommended continuing oral pirfenidone as long as possible even after surgery. Acute exacerbation prophylaxis is performed (not specified. but decided in each facility) | North East Japan Study Group | NULL | Recruiting | 20years-old | Not applicable | Male and Female | 230 | Phase 3 | Japan |
| 221 | EUCTR2016-003473-17-GB (EUCTR) | 14/09/2017 | 24/02/2017 | Investigation to Efficacy and Safety of CC-90001 in patients with Idiopathic Pulmonary Fibrosis | A Phase 2, 24-Week Randomized, Double-blind, Placebo-ControlledMulticenter Study, With an 80-Week Active Treatment Extension, toEvaluate the Efficacy and Safety of CC-90001 in Subjects with IdiopathicPulmonary Fibrosis | IDIOPATHIC PULMONARY FIBROSIS MedDRA version: 20.0;Level: LLT;Classification code 10067761;Term: Exacerbation of idiopathic pulmonary fibrosis;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Code: CC-90001 INN or Proposed INN: Not available | Celgene Corporation | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 210 | Phase 2 | Colombia;Russian Federation;Romania;United States;United Kingdom;Greece;Canada;Turkey;Taiwan;Brazil;Australia;France;Germany | ||
| 222 | JPRN-UMIN000026376 | 2017/09/01 | 03/03/2017 | Long-term Effect of Pulmonary Rehabilitation under Nintedanib treatment in Idiopathic Pulmonary Fibrosis | Long-term Effect of Pulmonary Rehabilitation under Nintedanib treatment in Idiopathic Pulmonary Fibrosis - Long-term Effect of Pulmonary Rehabilitation under Nintedanib treatment in IPF | Idiopathic pulmonary fibrosis(IPF) | Short-term induction pulmonary rehabilitation (2/1w for the first 12w) + Maintenance pulmonary rehabilitation and outpatient visit (1/4w) Total 52w. / No intervention Nintedanib / both group | Central Japan Lung Study Grou | NULL | Complete: follow-up complete | 40years-old | 80years-old | Male and Female | 84 | Phase 4 | Japan |
| 223 | EUCTR2017-001276-27-GB (EUCTR) | 21/08/2017 | 03/05/2017 | A study to determine if GBT440 can increase the level of oxygen in the blood of people with Idiopathic Pulmonary Fibrosis (IPF) who need to use supplemental oxygen when resting. | A Phase II open label study to evaluate the effect of GBT440 on hypoxemia in subjects with Idiopathic Pulmonary Fibrosis (IPF) who are using supplemental oxygen at rest (ZEPHYR) - ZEPHYR | Idiopathic Pulmonary Fibrosis (IPF) MedDRA version: 20.0;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders ;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: GBT440 300 mg capsule Product Code: GBT440 Product Name: GBT440 300 mg tablet Product Code: GBT440 | Global Blood Therapeutics Inc. | NULL | Not Recruiting | Female: yes Male: yes | 32 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | United States;United Kingdom | ||
| 224 | NCT03142191 (ClinicalTrials.gov) | July 26, 2017 | 24/4/2017 | A Study to Evaluate the Efficacy and Safety of CC-90001 in Subjects With Idiopathic Pulmonary Fibrosis | A Phase 2, 24-Week, Randomized, Double-blind, Placebo-controlled, Multicenter Study, With an 80-Week Active Treatment Extension, to Evaluate the Efficacy and Safety of CC-90001 in Subjects With Idiopathic Pulmonary Fibrosis | Idiopathic Pulmonary Fibrosis;Fibrosis;Idiopathic Interstitial Pneumonias;Pathologic Processes;Lung Diseases, Interstitial;Lung Diseases;Respiratory Tract Diseases | Drug: CC-90001;Other: Placebo | Celgene | NULL | Completed | 40 Years | N/A | All | 138 | Phase 2 | United States;Australia;Brazil;Canada;Colombia;Germany;Greece;Romania;Russian Federation;Taiwan;Turkey;Ukraine;United Kingdom;China |
| 225 | EUCTR2015-002619-14-FR (EUCTR) | 21/06/2017 | 25/04/2018 | Efficacy and safety of nintedanib co-administered with sildenafil in IPF patients with advanced lung function impairment | A 24-week, double-blind, randomized, parallel-group study evaluating the efficacy and safety of oral nintedanib coadministrated with oral sildenafil, compared to treatment with nintedanib alone, in patients with idiopathic pulmonary fibrosis (IPF) and advanced lung function impairment | patients with idiopathic pulmonary fibrosis (IPF) and advanced lung function impairment MedDRA version: 20.0;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Trade Name: Ofev Product Name: Ofev 100 mg capsule Product Code: nintedanib INN or Proposed INN: nintedanib Other descriptive name: NINTEDANIB Trade Name: Ofev Product Name: Ofev 150 mg capsule Product Code: nintedanib INN or Proposed INN: nintedanib Other descriptive name: NINTEDANIB Trade Name: Revatio Product Name: Revatio 20 mg Product Code: sildenafil INN or Proposed INN: SILDENAFIL Other descriptive name: sildenafil | Boehringer Ingelheim France | NULL | Not Recruiting | Female: yes Male: yes | 300 | Phase 3 | United States;Spain;Italy;United Kingdom;India;France;Mexico;Canada;Belgium;Australia;Germany;China;Japan;Korea, Republic of | ||
| 226 | JPRN-jRCTs071180049 | 23/05/2017 | 15/03/2019 | Japanese Intergroup Study of Nintedanib for NSCLC with IPF | A randomized phase III study of carboplatin plus nab-paclitaxel with or without nintedanib for advanced non-small-cell lung cancer with idiopathic pulmonary fibrosis - J-SONIC | Advanced Non-small cell lung cancer with idiopathic pulmonary fibrosis | carboplatin + nab-paclitaxel carboplatin + nab-paclitaxel + nintedanib | Okamoto Isamu | Otsubo Kohei | Complete | >= 20age old | Not applicable | Both | 240 | Phase 3 | Japan |
| 227 | NCT03092102 (ClinicalTrials.gov) | May 20, 2017 | 21/3/2017 | The Safety, Tolerability and Pharmacokinetic Study of HEC585 in Healthy Male and Female Subjects | A Phase I, Double-blind, Placebo-controlled, Single and Multiple Oral Dose, Safety, Tolerability and Pharmacokinetic Study of HEC585 in Healthy Male and Female Subjects | Idiopathic Pulmonary Fibrosis | Drug: HEC585 | Sunshine Lake Pharma Co., Ltd. | NULL | Completed | 18 Years | 60 Years | All | 136 | Phase 1 | United States |
| 228 | JPRN-UMIN000026799 | 2017/05/12 | 01/04/2017 | A randomized phse 3 study of carboplatin plus nab-paclitaxel with or without nintedanib for advanced non-small-cell lung cancer with idiopathic pulmonary fibrosis | A randomized phse 3 study of carboplatin plus nab-paclitaxel with or without nintedanib for advanced non-small-cell lung cancer with idiopathic pulmonary fibrosis - Japanese Intergroup Study of Nintedanib for NSCLC with IPF (J-SONIC) | Non-small-cell lung cancer with idiopathic pulmonary fibrosis | A: 4 cycles of Carboplatin (AUC 6, day 1) plus nab-Paclitaxel (100 mg/m2, day 1, 8, 15) repeated every 3 weeks B: 4 cycles of Carboplatin (AUC 6, day 1) plus nab-Paclitaxel (100 mg/m2, day 1, 8, 15) in combination with nintedanib (150 mg B.I.D, daily) repeated every 3 weeks followed by single-agent administration of nintedanib (150 mg B.I.D, daily) | Research Institute for Diseases of the Chest, Kyushu University | NULL | Complete: follow-up continuing | 20years-old | Not applicable | Male and Female | 240 | Phase 3 | Japan |
| 229 | EUCTR2016-003473-17-GR (EUCTR) | 05/05/2017 | 02/03/2017 | Investigation to Efficacy and Safety of CC-90001 in patients with Idiopathic Pulmonary Fibrosis | A Phase 2, 24-Week Randomized, Double-blind, Placebo-Controlled Multicenter Study, With an 80-Week Active Treatment Extension, to Evaluate the Efficacy and Safety of CC-90001 in Subjects with Idiopathic Pulmonary Fibrosis | IDIOPATHIC PULMONARY FIBROSIS MedDRA version: 20.0;Level: LLT;Classification code 10067761;Term: Exacerbation of idiopathic pulmonary fibrosis;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Code: CC-90001 | Celgene Corporation | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 135 | Phase 2 | United States;Taiwan;Greece;Turkey;Russian Federation;Colombia;United Kingdom;France;Canada;Brazil;Romania;Australia;Germany | ||
| 230 | NCT03211507 (ClinicalTrials.gov) | May 1, 2017 | 2/5/2017 | Idiopathic Pulmonary Fibrosis Job Exposures Study | Idiopathic Pulmonary Fibrosis Job Exposures Study | IPF;Idiopathic Pulmonary Fibrosis | Other: Computer-assisted telephone interview;Genetic: Genetic analysis | Imperial College London | Wellcome Trust;University Hospital Southampton NHS Foundation Trust;Imperial College Healthcare NHS Trust;Heart of England NHS Foundation Trust;Liverpool University Hospitals NHS Foundation Trust;Papworth Hospital NHS Foundation Trust;Nottingham University Hospitals NHS Trust;University Hospital of South Manchester;Guy's and St Thomas' NHS Foundation Trust;North Bristol NHS Trust;The Leeds Teaching Hospitals NHS Trust;Newcastle-upon-Tyne Hospitals NHS Trust;Royal Devon and Exeter NHS Foundation Trust;Somerset NHS Foundation Trust;Royal Infirmary of Edinburgh;Morriston Hospital;Aberdeen Royal Infirmary;Worcestershire Acute Hospitals NHS Trust;University Hospital Birmingham NHS Foundation Trust;Portsmouth Hospitals NHS Trust;Norfolk and Norwich University Hospitals NHS Foundation Trust;Glasgow Royal Infirmary | Completed | N/A | N/A | Male | 960 | United Kingdom | |
| 231 | NCT03115619 (ClinicalTrials.gov) | April 18, 2017 | 12/4/2017 | Quality of Life Study in Participants With IPF Under Pirfenidone Treatment | A Multicenter, Post-Marketing, Non-Interventional, Observational Study to Evaluate Quality of Life in Patients in Greece With Idiopathic Pulmonary Fibrosis Under Treatment With Pirfenidone - The Pneumon Study | Idiopathic Pulmonary Fibrosis | Drug: Pirfenidone | Hoffmann-La Roche | NULL | Completed | 18 Years | N/A | All | 102 | Greece | |
| 232 | ITMCTR2200005853 | 2017-04-09 | 2022-04-13 | Clinical observation of qizhufeixian Decoction in the treatment of idiopathic pulmonary interstitial fibrosis | Clinical observation of qizhufeixian Decoction in the treatment of idiopathic pulmonary interstitial fibrosis | Idiopathic pulmonary fibrosis | control group:N acetylcysteine;Treatment group:Bailing Capsule;:;control group:Bailing Capsule;Treatment group:Qizhu Feixian Decoction;Treatment group:N acetylcysteine; | Guang'anmen Hospital, Chinese Academy of traditional Chinese Medicine | NULL | Recruiting | Both | control group:20;Treatment group:20;:0;control group:20;Treatment group:20;Treatment group:20; | China | |||
| 233 | ChiCTR2200058641 | 2017-04-09 | 2022-04-13 | Clinical observation of qizhufeixian Decoction in the treatment of idiopathic pulmonary interstitial fibrosis | Clinical observation of qizhufeixian Decoction in the treatment of idiopathic pulmonary interstitial fibrosis | Idiopathic pulmonary fibrosis | control group:N acetylcysteine;control group:Bailing Capsule;Treatment group:N acetylcysteine;Treatment group:Bailing Capsule;Treatment group:Qizhu Feixian Decoction; | Guang'anmen Hospital, Chinese Academy of traditional Chinese Medicine | NULL | Recruiting | Both | control group:20;control group:20;Treatment group:20;Treatment group:20;Treatment group:20; | China | |||
| 234 | NCT02759120 (ClinicalTrials.gov) | March 22, 2017 | 28/4/2016 | CleanUP IPF for the Pulmonary Trials Cooperative | Study of Clinical Efficacy of Antimicrobial Therapy Strategy Using Pragmatic Design in Idiopathic Pulmonary Fibrosis | Idiopathic Pulmonary Fibrosis | Drug: Antimicrobial therapy: Co-trimoxazole or Doxycycline;Other: No Intervention: Standard of Care | Weill Medical College of Cornell University | Duke Clinical Research Institute;University of Chicago;University of Washington;University of Pittsburgh;National Heart, Lung, and Blood Institute (NHLBI) | Terminated | 40 Years | N/A | All | 509 | Phase 3 | United States |
| 235 | EUCTR2015-005131-40-CZ (EUCTR) | 20/03/2017 | 16/12/2016 | A Study to Evaluate the Efficacy, Safety, and Tolerability of Sildenafil Added to Pirfenidone in Patients with Advanced Idiopathic Pulmonary Fibrosis and Risk of Pulmonary Hypertension due to the lung disease. | A PHASE IIb, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE THE EFFICACY, SAFETY, AND TOLERABILITY OF SILDENAFIL ADDED TO PIRFENIDONE IN PATIENTS WITH ADVANCED IDIOPATHIC PULMONARY FIBROSIS AND RISK OF GROUP 3 PULMONARY HYPERTENSION. | Pulmonary Hypertension in patients with Idiopathic pulmonary fibrosis (IPF) MedDRA version: 20.0;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Trade Name: Esbriet Product Name: Esbriet Product Code: RO0220912 INN or Proposed INN: PIRFENIDONE Trade Name: Sildenafil Product Name: Sildenafil Product Code: RO0280296 INN or Proposed INN: SILDENAFIL | F. Hoffmann-La Roche Ltd | NULL | Not Recruiting | Female: yes Male: yes | 176 | Phase 2 | United Arab Emirates;Greece;Spain;Turkey;Israel;Italy;Egypt;Czech Republic;Hungary;Canada;Belgium;South Africa;Germany;Netherlands | ||
| 236 | EUCTR2015-005131-40-HU (EUCTR) | 16/01/2017 | 01/12/2016 | A Study to Evaluate the Efficacy, Safety, and Tolerability of Sildenafil Added to Pirfenidone in Patients with Advanced Idiopathic Pulmonary Fibrosis and Intermediate or High Probability of Pulmonary Hypertension due to the lung disease. | A PHASE IIb, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE THE EFFICACY, SAFETY, AND TOLERABILITY OF SILDENAFIL ADDED TO PIRFENIDONE IN PATIENTS WITH ADVANCED IDIOPATHIC PULMONARY FIBROSIS AND INTERMEDIATE OR HIGH PROBABILITY OF GROUP 3 PULMONARY HYPERTENSION. | Pulmonary Hypertension in patients with Idiopathic pulmonary fibrosis (IPF) MedDRA version: 19.0;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Trade Name: Esbriet Product Name: Esbriet Product Code: RO0220912 INN or Proposed INN: PIRFENIDONE Trade Name: Sildenafil Product Name: Sildenafil Product Code: RO0280296 INN or Proposed INN: SILDENAFIL | F. Hoffmann-La Roche Ltd | NULL | Not Recruiting | Female: yes Male: yes | 176 | Phase 2 | United Arab Emirates;Greece;Spain;Turkey;Israel;Italy;Egypt;Hungary;Czech Republic;Canada;Belgium;South Africa;Netherlands;Germany | ||
| 237 | NCT02951429 (ClinicalTrials.gov) | December 31, 2016 | 28/10/2016 | Efficacy, Safety, and Tolerability Study of Pirfenidone in Combination With Sildenafil in Participants With Advanced Idiopathic Pulmonary Fibrosis (IPF) and Intermediate or High Probability of Group 3 Pulmonary Hypertension | A Phase IIb, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Sildenafil Added to Pirfenidone in Patients With Advanced Idiopathic Pulmonary Fibrosis and Intermediate or High Probability of Group 3 Pulmonary Hypertension | Idiopathic Pulmonary Fibrosis | Drug: Pirfenidone;Drug: Placebo;Drug: Sildenafil | Hoffmann-La Roche | NULL | Completed | 40 Years | 80 Years | All | 177 | Phase 2 | Belgium;Canada;Czechia;Egypt;Germany;Greece;Hungary;Israel;Italy;Netherlands;South Africa;Spain;Turkey;Czech Republic;United Arab Emirates |
| 238 | EUCTR2015-005131-40-BE (EUCTR) | 16/12/2016 | 20/10/2016 | A Study to Evaluate the Efficacy, Safety, and Tolerability of Sildenafil Added to Pirfenidone in Patients with Advanced Idiopathic Pulmonary Fibrosis and Risk of Pulmonary Hypertension due to the lung disease. | A PHASE IIb, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE THE EFFICACY, SAFETY, AND TOLERABILITY OF SILDENAFIL ADDED TO PIRFENIDONE IN PATIENTS WITH ADVANCED IDIOPATHIC PULMONARY FIBROSIS AND RISK OF GROUP 3 PULMONARY HYPERTENSION. | Pulmonary Hypertension in patients with Idiopathic pulmonary fibrosis (IPF) MedDRA version: 21.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Trade Name: Esbriet Product Name: Esbriet Product Code: RO0220912 INN or Proposed INN: PIRFENIDONE Trade Name: Sildenafil Product Name: Sildenafil Product Code: RO0280296 INN or Proposed INN: SILDENAFIL | F. Hoffmann-La Roche Ltd | NULL | Not Recruiting | Female: yes Male: yes | 176 | Phase 2 | United Arab Emirates;Greece;Spain;Turkey;Israel;Italy;Egypt;Czech Republic;Hungary;Canada;Belgium;South Africa;Germany;Netherlands | ||
| 239 | NCT02874989 (ClinicalTrials.gov) | December 16, 2016 | 17/8/2016 | Targeting Pro-Inflammatory Cells in Idiopathic Pulmonary Fibrosis: a Human Trial | Targeted Removal of Pro-Inflammatory Cells: An Open Label Human Pilot Study in Idiopathic Pulmonary Fibrosis | Idiopathic Pulmonary Fibrosis (IPF) | Drug: Dasatinib + Quercetin;Drug: Placebo | Wake Forest University Health Sciences | Mayo Clinic;The University of Texas Health Science Center at San Antonio | Completed | 50 Years | N/A | All | 26 | Phase 1 | United States |
| 240 | EUCTR2015-005131-40-DE (EUCTR) | 08/12/2016 | 25/10/2016 | A Study to Evaluate the Efficacy, Safety, and Tolerability of Sildenafil Addedto Pirfenidone in Patients with Advanced Idiopathic Pulmonary Fibrosis andRisk of Pulmonary Hypertension due to the lung disease. | A PHASE IIb, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBOCONTROLLEDSTUDY TO EVALUATE THE EFFICACY, SAFETY, AND TOLERABILITY OF SILDENAFIL ADDED TO PIRFENIDONE IN PATIENTSWITH ADVANCED IDIOPATHIC PULMONARY FIBROSIS AND RISK OF GROUP 3 PULMONARY HYPERTENSION. | Pulmonary Hypertension in patients with Idiopathic pulmonary fibrosis (IPF) MedDRA version: 21.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Trade Name: Esbriet Product Name: Esbriet Product Code: RO0220912 INN or Proposed INN: PIRFENIDONE Trade Name: Sildenafil Product Name: Sildenafil Product Code: RO0280296 INN or Proposed INN: SILDENAFIL | F. Hoffmann-La Roche Ltd | NULL | Not Recruiting | Female: yes Male: yes | 176 | Phase 2 | United Arab Emirates;Greece;Spain;Turkey;Israel;Italy;Egypt;Czech Republic;Hungary;Canada;Belgium;South Africa;Germany;Netherlands | ||
| 241 | EUCTR2015-005131-40-GR (EUCTR) | 06/12/2016 | 03/11/2016 | A Study to Evaluate the Efficacy, Safety, and Tolerability of Sildenafil Added to Pirfenidone in Patients with Advanced Idiopathic Pulmonary Fibrosis and Intermediate or High Probability of Pulmonary Hypertension due to the lung disease. | A PHASE IIb, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE THE EFFICACY, SAFETY, AND TOLERABILITY OF SILDENAFIL ADDED TO PIRFENIDONE IN PATIENTS WITH ADVANCED IDIOPATHIC PULMONARY FIBROSIS AND INTERMEDIATE OR HIGH PROBABILITY OF GROUP 3 PULMONARY HYPERTENSION. | Pulmonary Hypertension in patients with Idiopathic pulmonary fibrosis (IPF) MedDRA version: 19.0;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Trade Name: Esbriet Product Name: Esbriet Product Code: RO0220912 INN or Proposed INN: PIRFENIDONE Trade Name: Sildenafil Product Name: Sildenafil Product Code: RO0280296 INN or Proposed INN: SILDENAFIL | F. Hoffmann-La Roche Ltd | NULL | Not Recruiting | Female: yes Male: yes | 176 | Phase 2 | United Arab Emirates;Greece;Spain;Turkey;Israel;Italy;Egypt;Czech Republic;Hungary;Canada;Belgium;South Africa;Germany;Netherlands | ||
| 242 | EUCTR2015-005131-40-NL (EUCTR) | 02/12/2016 | 13/10/2016 | A Study to Evaluate the Efficacy, Safety, and Tolerability of Sildenafil Added to Pirfenidone in Patients with Advanced Idiopathic Pulmonary Fibrosis and Risk of Pulmonary Hypertension due to the lung disease. | A PHASE IIb, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE THE EFFICACY, SAFETY, AND TOLERABILITY OF SILDENAFIL ADDED TO PIRFENIDONE IN PATIENTS WITH ADVANCED IDIOPATHIC PULMONARY FIBROSIS AND RISK OF GROUP 3 PULMONARY HYPERTENSION. | Pulmonary Hypertension in patients with Idiopathic pulmonary fibrosis (IPF) MedDRA version: 20.0;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Trade Name: Esbriet Product Name: Esbriet Product Code: RO0220912 INN or Proposed INN: PIRFENIDONE Trade Name: Sildenafil Product Name: Sildenafil Product Code: RO0280296 INN or Proposed INN: SILDENAFIL | F. Hoffmann-La Roche Ltd | NULL | Not Recruiting | Female: yes Male: yes | 176 | Phase 2 | United Arab Emirates;Greece;Spain;Turkey;Israel;Italy;Egypt;Czech Republic;Hungary;Canada;Belgium;South Africa;Netherlands;Germany | ||
| 243 | EUCTR2015-005131-40-IT (EUCTR) | 09/11/2016 | 25/05/2021 | A Study to Evaluate the Efficacy, Safety, and Tolerability of Sildenafil Added to Pirfenidone in Patients with Advanced Idiopathic Pulmonary Fibrosis and Risk of Pulmonary Hypertension due to the lung disease. | A PHASE IIb, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE THE EFFICACY, SAFETY, AND TOLERABILITY OF SILDENAFIL ADDED TO PIRFENIDONE IN PATIENTS WITH ADVANCED IDIOPATHIC PULMONARY FIBROSIS AND RISK OF GROUP 3 PULMONARY HYPERTENSION. - na | Pulmonary Hypertension in patients with Idiopathic pulmonary fibrosis (IPF) MedDRA version: 21.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Trade Name: Esbriet Product Name: ESBRIET Product Code: [RO0220912] INN or Proposed INN: 00322900 Trade Name: Sildenafil Product Name: sildenafil Product Code: [G048E03] INN or Proposed INN: 00258901 | F. HOFFMANN - LA ROCHE LTD. | NULL | Not Recruiting | Female: yes Male: yes | 176 | Phase 2 | United Arab Emirates;Czechia;Greece;Spain;Turkey;Israel;Italy;Egypt;Czech Republic;Hungary;Canada;Belgium;South Africa;Germany;Netherlands | ||
| 244 | EUCTR2015-003148-38-PL (EUCTR) | 08/11/2016 | 04/10/2016 | Effect of nintedanib on biomarkers | A 12-week, double blind, randomised, placebo controlled, parallel group trial followed by a single active arm phase of 40 weeks evaluating the effect of oral nintedanib 150 mg twice daily on change in biomarkers of extracellular matrix (ECM) turnover in patients with idiopathic pulmonary fibrosis (IPF) and limited forced vital capacity (FVC) impairment. | MedDRA version: 20.0;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Trade Name: Ofev Product Name: Ofev 100 mg capsule Product Code: nintedanib INN or Proposed INN: nintedanib Other descriptive name: NINTEDANIB Trade Name: Ofev Product Name: Ofev 150 mg capsule Product Code: nintedanib INN or Proposed INN: nintedanib Other descriptive name: NINTEDANIB | Boehringer Ingelheim RCV GmbH & Co KG | NULL | Not Recruiting | Female: yes Male: yes | 490 | Phase 4 | United States;Finland;Spain;United Kingdom;France;Czech Republic;Hungary;Poland;Belgium;Australia;Germany;Japan;Korea, Republic of | ||
| 245 | EUCTR2015-005131-40-ES (EUCTR) | 20/10/2016 | 09/09/2016 | A Study to Evaluate the Efficacy, Safety, and Tolerability of Sildenafil Added to Pirfenidone in Patients with Advanced Idiopathic Pulmonary Fibrosis and Intermediate or High Probability of Pulmonary Hypertension due to the lung disease. | A PHASE IIb, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE THE EFFICACY, SAFETY, AND TOLERABILITY OF SILDENAFIL ADDED TO PIRFENIDONE IN PATIENTS WITH ADVANCED IDIOPATHIC PULMONARY FIBROSIS AND INTERMEDIATE OR HIGH PROBABILITY OF GROUP 3 PULMONARY HYPERTENSION. | Pulmonary Hypertension in patients with Idiopathic pulmonary fibrosis (IPF) MedDRA version: 19.0;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Trade Name: Esbriet Product Name: Esbriet Product Code: RO0220912 INN or Proposed INN: PIRFENIDONE Trade Name: Sildenafil Product Name: Sildenafil Product Code: RO0280296 INN or Proposed INN: SILDENAFIL | F. Hoffmann-La Roche Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 176 | Phase 2 | United Arab Emirates;Greece;Spain;Turkey;Israel;Italy;Egypt;Czech Republic;Hungary;Canada;Belgium;South Africa;Germany;Netherlands | ||
| 246 | EUCTR2015-002619-14-IT (EUCTR) | 01/09/2016 | 04/06/2021 | Efficacy and safety of nintedanib when co-administered with sildenafil in IPF patients with advanced lung function impairment | INSTAGE(TM):A 24-week, double-blind, randomized, parallel-group study evaluating the efficacy and safety of oral nintedanib coadministrated with oral sildenafil, compared to treatment with nintedanib alone, in patients with idiopathic pulmonary fibrosis (IPF) and advanced lung function impairment - INSTAGE(TM) | patients with idiopathic pulmonary fibrosis (IPF) and advanced lung function impairment MedDRA version: 21.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Trade Name: Ofev Product Name: Ofev 100 mg capsule Product Code: nintedanib INN or Proposed INN: Nintedanib Trade Name: Ofev Product Name: Ofev 150 mg capsule Product Code: nintedanib INN or Proposed INN: Nintedanib Trade Name: Revatio Product Name: Revatio 20 mg Product Code: sildenafil INN or Proposed INN: SILDENAFIL | BOEHRINGER-INGELHEIM ITALIA S.P.A. | NULL | Not Recruiting | Female: yes Male: yes | 300 | Phase 3 | United States;Spain;United Kingdom;Italy;India;France;Mexico;Canada;Belgium;Australia;Germany;China;Japan;Korea, Republic of | ||
| 247 | EUCTR2014-004782-24-HU (EUCTR) | 09/08/2016 | 14/04/2016 | A Phase 2 Trial to Evaluate the Efficacy of PRM-151 in Subjects with Idiopathic Pulmonary Fibrosis (IPF) | A Phase 2 Trial to Evaluate the Efficacy of PRM-151 in Subjects with Idiopathic Pulmonary Fibrosis (IPF) | Idiopathic Pulmonary Fibrosis (IPF) MedDRA version: 19.0;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Body processes [G] - Circulatory and Respiratory Physiological Phenomena [G09] | Product Code: PRM-151 INN or Proposed INN: PRM-151 | Promedior, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 117 | Phase 2 | United States;Czech Republic;Hungary;Spain;Belgium;Israel;Netherlands;Germany;United Kingdom;Switzerland;Italy | ||
| 248 | EUCTR2015-002619-14-GB (EUCTR) | 01/08/2016 | 08/09/2016 | Efficacy and safety of nintedanib when co-administered with sildenafil in IPF patients with advanced lung function impairment | INSTAGE(TM): A 24-week, double-blind, randomized, parallel-group study evaluating the efficacy and safety of oral nintedanib coadministrated with oral sildenafil, compared to treatment with nintedanib alone, in patients with idiopathic pulmonary fibrosis (IPF) and advanced lung function impairment - INSTAGE(TM) | patients with idiopathic pulmonary fibrosis (IPF) and advanced lung function impairment MedDRA version: 19.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders ;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Trade Name: Ofev Product Name: Ofev 100 mg capsule Product Code: nintedanib INN or Proposed INN: nintedanib Other descriptive name: NINTEDANIB Trade Name: Ofev Product Name: Ofev 150 mg capsule Product Code: nintedanib INN or Proposed INN: nintedanib Other descriptive name: NINTEDANIB Trade Name: Revatio Product Name: Revatio 20 mg Product Code: sildenafil INN or Proposed INN: SILDENAFIL Other descriptive name: sildenafil | Boehringer Ingelheim Limited | NULL | Not Recruiting | Female: yes Male: yes | 300 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;Spain;United Kingdom;Italy;India;France;Mexico;Canada;Belgium;Australia;Germany;China;Japan;Korea, Republic of | ||
| 249 | NCT02885961 (ClinicalTrials.gov) | August 2016 | 15/8/2016 | The Coagulation Cascade in Idiopathic Pulmonary Fibrosis | Investigating the Role of the Coagulation Cascade in Idiopathic Pulmonary Fibrosis | Idiopathic Pulmonary Fibrosis;IPF;Interstitial Lung Disease | Drug: Dabigatran;Radiation: FDG PET scan | University College, London | NULL | Not yet recruiting | 40 Years | 80 Years | Both | 12 | N/A | NULL |
| 250 | EUCTR2015-002619-14-BE (EUCTR) | 25/07/2016 | 03/06/2016 | Efficacy and safety of nintedanib when co-administered with sildenafil in IPF patients with advanced lung function impairment | INSTAGE (TM) : A 24-week, double-blind, randomized, parallel-group study evaluating the efficacy and safety of oral nintedanib coadministrated with oral sildenafil, compared to treatment with nintedanib alone, in patients with idiopathic pulmonary fibrosis (IPF) and advanced lung function impairment - INSTAGE (TM) | patients with idiopathic pulmonary fibrosis (IPF) and advanced lung function impairment MedDRA version: 20.0;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Trade Name: Ofev Product Name: Ofev 100 mg capsule Product Code: nintedanib INN or Proposed INN: nintedanib Other descriptive name: NINTEDANIB Trade Name: Ofev Product Name: Ofev 150 mg capsule Product Code: nintedanib INN or Proposed INN: nintedanib Other descriptive name: NINTEDANIB Trade Name: Revatio Product Name: Revatio 20 mg Product Code: sildenafil INN or Proposed INN: SILDENAFIL Other descriptive name: sildenafil | SCS Boehringer Ingelheim Comm. V | NULL | Not Recruiting | Female: yes Male: yes | 300 | Phase 3 | United States;Spain;United Kingdom;Italy;India;France;Mexico;Canada;Belgium;Australia;Germany;China;Japan;Korea, Republic of | ||
| 251 | EUCTR2015-002619-14-DE (EUCTR) | 21/07/2016 | 04/05/2016 | Efficacy and safety of nintedanib when co-administered with sildenafil in IPF patients with advanced lung function impairment | INSTAGE(TM): A 24-week, double-blind, randomized, parallel-group study evaluating the efficacy and safety of oral nintedanib coadministrated with oral sildenafil, compared to treatment with nintedanib alone, in patients with idiopathic pulmonary fibrosis (IPF) and advanced lung function impairment - INSTAGE(TM) | patients with idiopathic pulmonary fibrosis (IPF) and advanced lung function impairment MedDRA version: 19.0;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Trade Name: Ofev Product Name: Ofev 100 mg capsule Product Code: nintedanib INN or Proposed INN: nintedanib Other descriptive name: NINTEDANIB Trade Name: Ofev Product Name: Ofev 150 mg capsule Product Code: nintedanib INN or Proposed INN: nintedanib Other descriptive name: NINTEDANIB Trade Name: Revatio Product Name: Revatio 20 mg Product Code: sildenafil INN or Proposed INN: SILDENAFIL Other descriptive name: sildenafil | Boehringer Ingelheim Pharma GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 300 | Phase 3 | United States;Spain;United Kingdom;Italy;India;France;Mexico;Canada;Belgium;Australia;Germany;China;Japan;Korea, Republic of | ||
| 252 | EUCTR2015-003148-38-DE (EUCTR) | 14/07/2016 | 20/05/2016 | Effect of nintedanib on biomarkers | A 12-week, double blind, randomised, placebo controlled, parallel group trial followed by a single active arm phase of 40 weeks evaluating the effect of oral nintedanib 150 mg twice daily on change in biomarkers of extracellular matrix (ECM) turnover in patients with idiopathic pulmonary fibrosis (IPF) and limited forced vital capacity (FVC) impairment. | MedDRA version: 20.0;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders ;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Trade Name: Ofev Product Name: Ofev 100 mg capsule Product Code: nintedanib INN or Proposed INN: nintedanib Other descriptive name: NINTEDANIB Trade Name: Ofev Product Name: Ofev 150 mg capsule Product Code: nintedanib INN or Proposed INN: nintedanib Other descriptive name: NINTEDANIB | Boehringer Ingelheim Pharma GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 490 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yes | United States;Finland;Spain;United Kingdom;France;Czech Republic;Hungary;Belgium;Poland;Australia;Germany;Japan;Korea, Republic of | ||
| 253 | NCT02802345 (ClinicalTrials.gov) | June 30, 2016 | 14/6/2016 | Efficacy and Safety of Nintedanib Co-administered With Sildenafil in Idiopathic Pulmonary Fibrosis Patients With Advanced Lung Function Impairment | INSTAGE: A 24-week, Double-blind, Randomized, Parallel-group Study Evaluating the Efficacy and Safety of Oral Nintedanib Co-administered With Oral Sildenafil, Compared to Treatment With Nintedanib Alone, in Patients With Idiopathic Pulmonary Fibrosis (IPF) and Advanced Lung Function Impairment | Idiopathic Pulmonary Fibrosis | Drug: Nintedanib;Drug: Placebo;Drug: Sildenafil | Boehringer Ingelheim | NULL | Completed | 40 Years | N/A | All | 274 | Phase 3 | United States;Australia;Belgium;Canada;France;Germany;India;Italy;Japan;Korea, Republic of;Mexico;Spain;United Kingdom |
| 254 | EUCTR2015-002619-14-ES (EUCTR) | 29/06/2016 | 17/05/2016 | Efficacy and safety of nintedanib when co-administered with sildenafil in IPF patients with advanced lung function impairment | A 24-week, double-blind, randomized, parallel-group study evaluating the efficacy and safety of oral nintedanib coadministrated with oral sildenafil, compared to treatment with nintedanib alone, in patients with idiopathic pulmonary fibrosis (IPF) and advanced lung function impairment | patients with idiopathic pulmonary fibrosis (IPF) and advanced lung function impairment MedDRA version: 19.0;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Trade Name: Ofev Product Name: Ofev 100 mg capsule Product Code: nintedanib INN or Proposed INN: nintedanib Other descriptive name: NINTEDANIB Trade Name: Ofev Product Name: Ofev 150 mg capsule Product Code: nintedanib INN or Proposed INN: nintedanib Other descriptive name: NINTEDANIB Trade Name: Revatio Product Name: Revatio 20 mg Product Code: sildenafil INN or Proposed INN: SILDENAFIL Other descriptive name: sildenafil | Boehringer Ingelheim España, S.A. | NULL | Not Recruiting | Female: yes Male: yes | 300 | Phase 3 | United States;Spain;United Kingdom;Italy;India;France;Mexico;Canada;Belgium;Australia;Germany;China;Japan;Korea, Republic of | ||
| 255 | EUCTR2015-003148-38-ES (EUCTR) | 13/06/2016 | 11/03/2016 | Effect of nintedanib on biomarkers | A 12-week, double blind, randomised, placebo controlled, parallel group trial followed by a single active arm phase of 40 weeks evaluating the effect of oral nintedanib 150 mg twice daily on change in biomarkers of extracellular matrix (ECM) turnover in patients with idiopathic pulmonary fibrosis (IPF) and limited forced vital capacity (FVC) impairment. | MedDRA version: 18.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Trade Name: Ofev Product Name: Ofev 100 mg capsule Product Code: nintedanib INN or Proposed INN: nintedanib Other descriptive name: NINTEDANIB Trade Name: Ofev Product Name: Ofev 150 mg capsule Product Code: nintedanib INN or Proposed INN: nintedanib Other descriptive name: NINTEDANIB | Boehringer Ingelheim España, S.A. | NULL | Not Recruiting | Female: yes Male: yes | 490 | Phase 4 | United States;Finland;Spain;United Kingdom;France;Czech Republic;Hungary;Belgium;Poland;Australia;Germany;Japan;Korea, Republic of | ||
| 256 | NCT02788474 (ClinicalTrials.gov) | June 9, 2016 | 27/5/2016 | Effect of Nintedanib on Biomarkers of Extracellular Matrix Turnover in Patients With Idiopathic Pulmonary Fibrosis and Limited Forced Vital Capacity Impairment | A 12-week, Double Blind, Randomised, Placebo Controlled, Parallel Group Trial Followed by a Single Active Arm Phase of 40 Weeks Evaluating the Effect of Oral Nintedanib 150 mg Twice Daily on Change in Biomarkers of Extracellular Matrix (ECM) Turnover in Patients With Idiopathic Pulmonary Fibrosis (IPF) and Limited Forced Vital Capacity (FVC) Impairment. | Idiopathic Pulmonary Fibrosis | Drug: nintedanib;Drug: placebo | Boehringer Ingelheim | NULL | Completed | 40 Years | N/A | All | 347 | Phase 4 | United States;Australia;Belgium;Czechia;Finland;France;Germany;Hungary;Japan;Korea, Republic of;Poland;Spain;United Kingdom;Czech Republic |
| 257 | EUCTR2015-003148-38-BE (EUCTR) | 06/06/2016 | 19/04/2016 | Effect of nintedanib on biomarkers | A 12-week, double blind, randomised, placebo controlled, parallel group trial followed by a single active arm phase of 40 weeks evaluating the effect of oral nintedanib 150 mg twice daily on change in biomarkers of extracellular matrix (ECM) turnover in patients with idiopathic pulmonary fibrosis (IPF) and limited forced vital capacity (FVC) impairment. | MedDRA version: 20.0;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Trade Name: Ofev Product Name: Ofev 100 mg capsule Product Code: nintedanib INN or Proposed INN: nintedanib Other descriptive name: NINTEDANIB Trade Name: Ofev Product Name: Ofev 150 mg capsule Product Code: nintedanib INN or Proposed INN: nintedanib Other descriptive name: NINTEDANIB | SCS Boehringer Ingelheim Comm. V | NULL | Not Recruiting | Female: yes Male: yes | 490 | Phase 4 | United States;Finland;Spain;United Kingdom;France;Czech Republic;Hungary;Belgium;Poland;Australia;Germany;Japan;Korea, Republic of | ||
| 258 | EUCTR2015-003148-38-GB (EUCTR) | 06/06/2016 | 18/04/2016 | Effect of nintedanib on biomarkers | A 12-week, double blind, randomised, placebo controlled, parallel group trial followed by a single active arm phase of 40 weeks evaluating the effect of oral nintedanib 150 mg twice daily on change in biomarkers of extracellular matrix (ECM) turnover in patients with idiopathic pulmonary fibrosis (IPF) and limited forced vital capacity (FVC) impairment. | MedDRA version: 19.0;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders ;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Trade Name: Ofev Product Name: Ofev 100 mg capsule Product Code: nintedanib INN or Proposed INN: nintedanib Other descriptive name: NINTEDANIB Trade Name: Ofev Product Name: Ofev 150 mg capsule Product Code: nintedanib INN or Proposed INN: nintedanib Other descriptive name: NINTEDANIB | Boehringer Ingelheim Limited | NULL | Not Recruiting | Female: yes Male: yes | 490 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yes | United States;Finland;Spain;United Kingdom;France;Czech Republic;Hungary;Belgium;Poland;Australia;Germany;Japan;Korea, Republic of | ||
| 259 | NCT02846324 (ClinicalTrials.gov) | June 2016 | 7/7/2016 | Study to Evaluate the Safety and Tolerability of GBT440 Administered to Subjects With IPF | A Phase II Randomized, Placebo-Controlled Study of GBT440 to Evaluate the Safety, Tolerability, Pharmacokinetics and Effect on Hypoxemia in Subjects With Idiopathic Pulmonary Fibrosis (IPF) | Idiopathic Pulmonary Fibrosis;Hypoxemia | Drug: GBT440;Drug: Placebo | Global Blood Therapeutics | NULL | Completed | 45 Years | 80 Years | All | 39 | Phase 2 | United States |
| 260 | EUCTR2015-003148-38-HU (EUCTR) | 27/05/2016 | 12/04/2016 | Effect of nintedanib on biomarkers | A 12-week, double blind, randomised, placebo controlled, parallel group trial followed by a single active arm phase of 40 weeks evaluating the effect of oral nintedanib 150 mg twice daily on change in biomarkers of extracellular matrix (ECM) turnover in patients with idiopathic pulmonary fibrosis (IPF) and limited forced vital capacity (FVC) impairment. | MedDRA version: 18.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Trade Name: Ofev Product Name: Ofev 100 mg capsule Product Code: nintedanib INN or Proposed INN: nintedanib Other descriptive name: NINTEDANIB Trade Name: Ofev Product Name: Ofev 150 mg capsule Product Code: nintedanib INN or Proposed INN: nintedanib Other descriptive name: NINTEDANIB | Boehringer Ingelheim RCV GmbH & Co KG | NULL | Not Recruiting | Female: yes Male: yes | 490 | Phase 4 | United States;Finland;Spain;United Kingdom;France;Hungary;Czech Republic;Belgium;Poland;Australia;Germany;Japan;Korea, Republic of | ||
| 261 | EUCTR2015-003148-38-CZ (EUCTR) | 26/05/2016 | 11/04/2016 | Effect of nintedanib on biomarkers | A 12-week, double blind, randomised, placebo controlled, parallel group trial followed by a single active arm phase of 40 weeks evaluating the effect of oral nintedanib 150 mg twice daily on change in biomarkers of extracellular matrix (ECM) turnover in patients with idiopathic pulmonary fibrosis (IPF) and limited forced vital capacity (FVC) impairment. | MedDRA version: 18.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Trade Name: Ofev Product Name: Ofev 100 mg capsule Product Code: nintedanib INN or Proposed INN: nintedanib Other descriptive name: NINTEDANIB Trade Name: Ofev Product Name: Ofev 150 mg capsule Product Code: nintedanib INN or Proposed INN: nintedanib Other descriptive name: NINTEDANIB | Boehringer Ingelheim RCV GmbH & Co KG | NULL | Not Recruiting | Female: yes Male: yes | 490 | Phase 4 | Finland;Spain;United Kingdom;France;Czech Republic;Hungary;Belgium;Poland;Australia;Germany;Japan;Korea, Republic of;United States | ||
| 262 | NCT02688647 (ClinicalTrials.gov) | May 26, 2016 | 18/2/2016 | A 2-Part, Phase 2 Open-label and Crossover Study of Belumosudil for Treatment of Idiopathic Pulmonary Fibrosis | A Randomized, Phase 2, Open-Label, Multicenter Study to Evaluate the Safety, Tolerability, and Activity of Belumosudil in Subjects With Idiopathic Pulmonary Fibrosis (IPF) | Idiopathic Pulmonary Fibrosis | Drug: Belumosudil;Other: BSC | Kadmon Corporation, LLC | NULL | Completed | 18 Years | N/A | All | 76 | Phase 2 | United States |
| 263 | EUCTR2015-003148-38-FR (EUCTR) | 24/05/2016 | 04/05/2016 | Effect of nintedanib on biomarkers | A 12-week, double blind, randomised, placebo controlled, parallel group trial followed by a single active arm phase of 40 weeks evaluating the effect of oral nintedanib 150 mg twice daily on change in biomarkers of extracellular matrix (ECM) turnover in patients with idiopathic pulmonary fibrosis (IPF) and limited forced vital capacity (FVC) impairment. | MedDRA version: 19.0;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Trade Name: Ofev Product Name: Ofev 100 mg capsule Product Code: nintedanib INN or Proposed INN: nintedanib Other descriptive name: NINTEDANIB Trade Name: Ofev Product Name: Ofev 150 mg capsule Product Code: nintedanib INN or Proposed INN: nintedanib Other descriptive name: NINTEDANIB | Boehringer Ingelheim France | NULL | Not Recruiting | Female: yes Male: yes | 490 | Phase 4 | United States;Finland;Spain;United Kingdom;France;Czech Republic;Hungary;Belgium;Poland;Australia;Germany;Japan;Korea, Republic of | ||
| 264 | EUCTR2015-003148-38-FI (EUCTR) | 17/05/2016 | 12/04/2016 | Effect of nintedanib on biomarkers | A 12-week, double blind, randomised, placebo controlled, parallel group trial followed by a single active arm phase of 40 weeks evaluating the effect of oral nintedanib 150 mg twice daily on change in biomarkers of extracellular matrix (ECM) turnover in patients with idiopathic pulmonary fibrosis (IPF) and limited forced vital capacity (FVC) impairment. | MedDRA version: 19.0;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Trade Name: Ofev Product Name: Ofev 100 mg capsule Product Code: nintedanib INN or Proposed INN: nintedanib Other descriptive name: NINTEDANIB Trade Name: Ofev Product Name: Ofev 150 mg capsule Product Code: nintedanib INN or Proposed INN: nintedanib Other descriptive name: NINTEDANIB | Boehringer Ingelheim Finland Ky | NULL | Not Recruiting | Female: yes Male: yes | 490 | Phase 4 | United States;Finland;Spain;United Kingdom;France;Czech Republic;Hungary;Belgium;Poland;Australia;Germany;Japan;Korea, Republic of | ||
| 265 | EUCTR2015-004157-41-IT (EUCTR) | 13/05/2016 | 01/10/2021 | Randomized, Double-Blind, Parallel Group, Placebo-Controlled, Multicenter, Exploratory Phase IIa Study to Assess Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Properties of GLPG1690 Administered for 12 Weeks in Subjects with Idiopathic Pulmonary Fibrosis (IPF) | Randomized, Double-Blind, Parallel Group, Placebo-Controlled, Multicenter, Exploratory Phase IIa Study to Assess Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Properties of GLPG1690 Administered for 12 Weeks in Subjects with Idiopathic Pulmonary Fibrosis (IPF) - Randomized, Double-Blind, Parallel Group, Placebo-Controlled, Multicenter, Exploratory Phase IIa Stu | Idiopathic pulmonary fibrosis (IPF) MedDRA version: 21.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: GLPG1690 Product Code: G451990 Other descriptive name: GLPG1690 | GALAPAGOS NV | NULL | Not Recruiting | Female: yes Male: yes | 24 | Phase 2 | United Kingdom;Italy | ||
| 266 | JPRN-JapicCTI-163326 | 01/5/2016 | 22/07/2016 | Phase III clinical study of ART-123 for the treatment of acute exacerbation of idiopathic pulmonary fibrosis | Phase III clinical study of ART-123 for the treatment of acute exacerbation of idiopathic pulmonary fibrosis | Acute exacerbation of idiopathic pulmonary fibrosis (AE-IPF) | Intervention name : ART-123 INN of the intervention : thrombomodulin alfa Dosage And administration of the intervention : 380 U/kg/day by intravenous drip infusion in addition to standard of care steroid therapy Control intervention name : Placebo Dosage And administration of the control intervention : Placebo by intravenous drip infusion in addition to standard of care steroid therapy | ASAHI KASEI PHARMA CORPORATION | NULL | recruiting | 40 | 85 | BOTH | Phase 3 | NULL | |
| 267 | NCT02739165 (ClinicalTrials.gov) | May 2016 | 1/4/2016 | Clinical Study of ART-123 for the Treatment of Acute Exacerbation of Idiopathic Pulmonary Fibrosis | Phase III Clinical Study of ART-123 for the Treatment of Acute Exacerbation of Idiopathic Pulmonary Fibrosis: a Multicenter Randomized Placebo-controlled Double-blind Study to Assess the Efficacy and Safety of ART-123 | Idiopathic Pulmonary Fibrosis | Drug: ART-123;Drug: Placebo | Asahi Kasei Pharma Corporation | NULL | Completed | 40 Years | 85 Years | All | 74 | Phase 3 | Japan |
| 268 | EUCTR2015-003280-11-NL (EUCTR) | 29/04/2016 | 19/01/2016 | A Study of the Safety and Tolerability of Pirfenidone (Esbriet) in Combination with Nintedanib (Ofev) in Patients with Idiopathic Pulmonary Fibrosis | AN EXPLORATORY MULTICENTER, OPEN-LABEL, SINGLE ARM STUDY OF THE SAFETY AND TOLERABILITY OF PIRFENIDONE (ESBRIET®) IN COMBINATION WITH NINTEDANIB (OFEV®) IN PATIENTS WITH IDIOPATHIC PULMONARY FIBROSIS | Idiopathic Pulmonary Fibrosis (IPF) MedDRA version: 19.0;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Trade Name: Esbriet Product Name: Esbriet Product Code: RO0220912 INN or Proposed INN: PIRFENIDONE Trade Name: Ofev Product Name: Ofev Product Code: 534-1508 INN or Proposed INN: NINTEDANIB Trade Name: Ofev Product Name: Ofev Product Code: 534-1508 INN or Proposed INN: NINTEDANIB | F. Hoffmann-La Roche Ltd | NULL | Not Recruiting | Female: yes Male: yes | 80 | Phase 4 | France;United States;Canada;Spain;Denmark;Germany;Netherlands;Italy | ||
| 269 | EUCTR2014-004782-24-CZ (EUCTR) | 25/04/2016 | 11/08/2015 | A study to test intravenous PRM-151 for safety and to see how PRM-151 acts in the body and blood of people with idiopathic pulmonary fibrosis (IPF) - a disorder where lung tissue becomes damaged and scarred making it difficult to breathe. | A Phase 2 Trial to Evaluate the Efficacy of PRM-151 in Subjects with Idiopathic Pulmonary Fibrosis (IPF) | Idiopathic Pulmonary Fibrosis (IPF) MedDRA version: 20.0;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders ;Therapeutic area: Body processes [G] - Circulatory and Respiratory Physiological Phenomena [G09] | Product Code: PRM-151 INN or Proposed INN: PRM-151 | Promedior, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 117 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | France;United States;Hungary;Czech Republic;Spain;Belgium;Netherlands;Germany;United Kingdom | ||
| 270 | JPRN-UMIN000022037 | 2016/04/19 | 24/04/2016 | The pilot study of nivolumab for advanced NSCLC patients with IIPs which is clinically considered to be at low risk of acute exacerbation of IIPs. | The pilot study of nivolumab for advanced NSCLC patients with IIPs which is clinically considered to be at low risk of acute exacerbation of IIPs. - IP-NSCLC nivolumab study | Advanced NSCLC patients with IIPs | Nivolumab 3mg/kg, every 2 weeks | Kobe city medical center general hospital | NULL | Complete: follow-up complete | 20years-old | 100years-old | Male and Female | 6 | Not selected | Japan |
| 271 | NCT02606877 (ClinicalTrials.gov) | April 19, 2016 | 16/11/2015 | A Study to Compare the Amount of Nintedanib and Pirfenidone in the Blood When Nintedanib and Pirfenidone Are Given Separately or in Combination | Investigation of Drug-drug Interaction Between Nintedanib and Pirfenidone in Patients With IPF (an Open Label, Multiple-dose, Two Group Study) | Idiopathic Pulmonary Fibrosis | Drug: nintedanib;Drug: pirfenidone | Boehringer Ingelheim | NULL | Completed | 40 Years | N/A | All | 37 | Phase 4 | United Kingdom |
| 272 | JPRN-UMIN000021591 | 2016/04/04 | 01/04/2016 | The pilot study of Nintedanib and Carboplatin plus Paclitaxel for advanced non-small cell lung cancer with idiopathic interstitial pneumonia | The pilot study of Nintedanib and Carboplatin plus Paclitaxel for advanced non-small cell lung cancer with idiopathic interstitial pneumonia - The pilot study of Nintedanib and Carboplatin plus Paclitaxel for advanced non-small cell lung cancer with idiopathic interstitial pneumonia | Advanced non-small cell lung cancer with idiopathic interstitial pneumonia | carboplatin AUC6 D1 paclitaxel 200mg/m D1 tryweekly 4cycle nintedanib 150mg twice daily | Hirosaki University Graduate School of Medicine | NULL | Complete: follow-up complete | 20years-old | Not applicable | Male and Female | 30 | Not selected | Japan |
| 273 | EUCTR2014-004782-24-ES (EUCTR) | 31/03/2016 | 15/12/2015 | A study to test intravenous PRM-151 for safety and to see how PRM-151 acts in the body and blood of people with idiopathic pulmonary fibrosis (IPF) - a disorder where lung tissue becomes damaged and scarred making it difficult to breathe. | A Phase 2 Trial to Evaluate the Efficacy of PRM-151 in Subjects with Idiopathic Pulmonary Fibrosis (IPF) | Idiopathic Pulmonary Fibrosis (IPF) MedDRA version: 18.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders ;Therapeutic area: Body processes [G] - Circulatory and Respiratory Physiological Phenomena [G09] | Product Code: PRM-151 INN or Proposed INN: PRM-151 | Promedior, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 117 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | United States;Hungary;Czech Republic;Belgium;Spain;Netherlands;Germany;United Kingdom | ||
| 274 | EUCTR2015-004157-41-GB (EUCTR) | 21/03/2016 | 02/12/2015 | Randomized, Double-Blind, Parallel Group, Placebo-Controlled, Multicenter, Exploratory Phase IIa Study to Assess Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Properties of GLPG1690 Administered for 12 Weeks in Subjects with Idiopathic Pulmonary Fibrosis (IPF) | Randomized, Double-Blind, Parallel Group, Placebo-Controlled, Multicenter, Exploratory Phase IIa Study to Assess Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Properties of GLPG1690 Administered for 12 Weeks in Subjects with Idiopathic Pulmonary Fibrosis (IPF) | Idiopathic pulmonary fibrosis (IPF) MedDRA version: 18.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders ;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: GLPG1690 Product Code: G451990 Other descriptive name: GLPG1690 | Galapagos NV | NULL | Not Recruiting | Female: yes Male: yes | 24 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | Ukraine;United Kingdom | ||
| 275 | NCT02503657 (ClinicalTrials.gov) | March 9, 2016 | 14/7/2015 | Safety and Tolerability Study in Subjects With Idiopathic Pulmonary Fibrosis (IPF) | A Randomized, Placebo-Controlled, Double-Blind Six Month Study Followed by an Open-Label Extension Phase to Evaluate the Efficacy, Safety and Tolerability of MN-001 in Subjects With Idiopathic Pulmonary Fibrosis (IPF) | Idiopathic Pulmonary Fibrosis;IPF | Drug: tipelukast;Drug: Placebo | MediciNova | NULL | Completed | 21 Years | 80 Years | All | 15 | Phase 2 | United States |
| 276 | EUCTR2014-004782-24-DE (EUCTR) | 01/03/2016 | 19/05/2015 | A study to test intravenous PRM-151 for safety and to see how PRM-151 acts in the body and blood of people with idiopathic pulmonary fibrosis (IPF) - a disorder where lung tissue becomes damaged and scarred making it difficult to breathe. | A Phase 2 Trial to Evaluate the Efficacy of PRM-151 in Subjects with Idiopathic Pulmonary Fibrosis (IPF) | Idiopathic Pulmonary Fibrosis (IPF) MedDRA version: 18.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Body processes [G] - Circulatory and Respiratory Physiological Phenomena [G09] | Product Code: PRM-151 INN or Proposed INN: PRM-151 | Promedior, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 117 | Phase 2 | United States;Hungary;Czech Republic;Spain;Belgium;Israel;Netherlands;Germany;United Kingdom;Switzerland;Italy | ||
| 277 | NCT02738801 (ClinicalTrials.gov) | March 2016 | 11/4/2016 | Study to Assess Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Properties of GLPG1690 in Subjects With Idiopathic Pulmonary Fibrosis (IPF) | Randomized, Double-Blind, Parallel Group, Placebo-Controlled, Multicenter, Exploratory Phase IIa Study to Assess Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Properties of GLPG1690 Administered for 12 Weeks in Subjects With Idiopathic Pulmonary Fibrosis (IPF) | Idiopathic Pulmonary Fibrosis | Drug: GLPG1690 600 mg QD;Drug: Placebo QD | Galapagos NV | NULL | Completed | 40 Years | N/A | All | 23 | Phase 2 | Ukraine;United Kingdom;Italy |
| 278 | EUCTR2015-003280-11-DE (EUCTR) | 25/02/2016 | 19/10/2015 | A Study of the Safety and Tolerability of Pirfenidone (Esbriet) in Combination with Nintedanib (Ofev) in Patients with Idiopathic Pulmonary Fibrosis | AN EXPLORATORY MULTICENTER, OPEN-LABEL, SINGLE ARM STUDY OF THE SAFETY AND TOLERABILITY OF PIRFENIDONE (ESBRIET®) IN COMBINATION WITH NINTEDANIB (OFEV®) IN PATIENTS WITH IDIOPATHIC PULMONARY FIBROSIS | Idiopathic Pulmonary Fibrosis (IPF) MedDRA version: 19.0;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Trade Name: Esbriet Product Name: Esbriet Product Code: RO0220912 INN or Proposed INN: PIRFENIDONE Trade Name: Ofev Product Name: Ofev Product Code: 534-1508 INN or Proposed INN: NINTEDANIB Trade Name: Ofev Product Name: Ofev Product Code: 534-1508 INN or Proposed INN: NINTEDANIB | F. Hoffmann-La Roche Ltd | NULL | Not Recruiting | Female: yes Male: yes | 80 | Phase 4 | France;United States;Canada;Spain;Denmark;Netherlands;Germany;Italy | ||
| 279 | EUCTR2014-005658-20-BG (EUCTR) | 23/02/2016 | 18/12/2015 | FG-3019 treatment in Idiopathic Pulmonary Fibrosis (IPF) patients. | A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of FG-3019 in Patients with Idiopathic Pulmonary Fibrosis | Idiopathic Pulmonary Fibrosis MedDRA version: 19.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders MedDRA version: 19.1;Level: SOC;Classification code 10038738;Term: Respiratory, thoracic and mediastinal disorders;Level: HLT;Classification code 10033979;Term: Parenchymal lung disorders NEC;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: FG-3019 10mg/mL in 10 mL vials Product Code: FG-3019 INN or Proposed INN: Pamrevlumab | FibroGen, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 136 | Phase 2 | United States;Canada;Australia;South Africa;Bulgaria;New Zealand;India | ||
| 280 | EUCTR2014-003933-24-PT (EUCTR) | 15/02/2016 | 07/10/2015 | Efficacy and Safety of SAR156597 in the Treatment of Idiopathic Pulmonary Fibrosis | Efficacy and Safety of SAR156597 in the Treatment of Idiopathic Pulmonary Fibrosis (IPF): A Randomized, Double-blind, Placebo-controlled, 52-week Dose-ranging Study - ESTAIR | Idiopathic pulmonary fibrosis MedDRA version: 19.0;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders ;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Code: SAR156597 INN or Proposed INN: NA | sanofi-aventis recherche & développement | NULL | Not Recruiting | Female: yes Male: yes | 300 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | Portugal;United States;Greece;Spain;Turkey;Israel;Chile;Colombia;Italy;United Kingdom;France;Czech Republic;Mexico;Canada;Argentina;Australia;Denmark;Germany;Korea, Republic of | ||
| 281 | JPRN-UMIN000020722 | 2016/01/26 | 25/01/2016 | Prospective study of efficiency of fibrosis score in computed tomography as predictor after treatment with Nintedanib for idiopathic pulmonary fibrosis | Prospective study of efficiency of fibrosis score in computed tomography as predictor after treatment with Nintedanib for idiopathic pulmonary fibrosis - The CT study with Nintedanib | idiopathic pulmonary fibrosis | administration of 150mg of nintedanib twice daily | Kanagawa Cardiovascular and Respiratory Center | NULL | Recruiting | 40years-old | Not applicable | Male and Female | 30 | Not applicable | Japan |
| 282 | JPRN-UMIN000020682 | 2016/01/22 | 22/01/2016 | The comparison of the efficacy and safety of pirfenidone and nintedanib in patients with idiopathic pulmonary fibrosis | The comparison of the efficacy and safety of pirfenidone and nintedanib in patients with idiopathic pulmonary fibrosis - The comparison of antifibrotic agents in patients with idiopathic pulmonary fibrosis | Idiopathic pulmonary fibrosis | pirfenidone 12 months 200-600mg t.i.d or b.i.d nintedanib 12 months 100-150mg b.i.d | National Hospital Organization Ibarakihigashi National HospitalThe center of Chest Diseases and Severe Motor&Intellectual Disabilities | NULL | Pending | 20years-old | Not applicable | Male and Female | 60 | Not applicable | Japan |
| 283 | EUCTR2015-003280-11-DK (EUCTR) | 20/01/2016 | 25/11/2015 | A Study of the Safety and Tolerability of Pirfenidone (Esbriet) in Combination with Nintedanib (Ofev) in Patients with Idiopathic Pulmonary Fibrosis | AN EXPLORATORY MULTICENTER, OPEN-LABEL, SINGLE ARM STUDY OF THE SAFETY AND TOLERABILITY OF PIRFENIDONE (ESBRIET®) IN COMBINATION WITH NINTEDANIB (OFEV®) IN PATIENTS WITH IDIOPATHIC PULMONARY FIBROSIS | Idiopathic Pulmonary Fibrosis (IPF) MedDRA version: 19.0;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Trade Name: Esbriet Product Name: Esbriet Product Code: RO0220912 INN or Proposed INN: PIRFENIDONE Trade Name: Ofev Product Name: Ofev Product Code: 534-1508 INN or Proposed INN: NINTEDANIB Trade Name: Ofev Product Name: Ofev Product Code: 534-1508 INN or Proposed INN: NINTEDANIB | F. Hoffmann-La Roche Ltd | NULL | Not Recruiting | Female: yes Male: yes | 80 | Phase 4 | France;United States;Canada;Spain;Denmark;Netherlands;Germany;Italy | ||
| 284 | NCT02648048 (ClinicalTrials.gov) | January 15, 2016 | 5/1/2016 | A Study of Oral Vismodegib in Combination With Pirfenidone in Participants With Idiopathic Pulmonary Fibrosis | A Single Arm, Multicenter, Open-label, Phase 1b Study to Assess the Safety and Tolerability of Oral Vismodegib in Combination With Pirfenidone in Patients With Idiopathic Pulmonary Fibrosis | Idiopathic Pulmonary Fibrosis | Drug: Pirfenidone;Drug: Vismodegib | Hoffmann-La Roche | NULL | Completed | 40 Years | 80 Years | All | 21 | Phase 1 | United States;Germany |
| 285 | NCT02598193 (ClinicalTrials.gov) | January 14, 2016 | 4/11/2015 | Safety and Tolerability Study of Pirfenidone in Combination With Nintedanib in Participants With Idiopathic Pulmonary Fibrosis (IPF) | An Exploratory Multicenter, Open-Label, Single Arm Study of the Safety and Tolerability of Pirfenidone (Esbriet®) in Combination With Nintedanib (Ofev®) in Patients With Idiopathic Pulmonary Fibrosis | Idiopathic Pulmonary Fibrosis | Drug: Nintedanib;Drug: Pirfenidone | Hoffmann-La Roche | NULL | Completed | 40 Years | 80 Years | All | 89 | Phase 4 | United States;Canada;Denmark;France;Germany;Italy;Netherlands;Spain |
| 286 | EUCTR2015-000640-42-IT (EUCTR) | 22/12/2015 | 22/02/2018 | Safety, tolerability and PK of nintedanib in combination with pirfenidone in IPF | A twelve week, open-label, randomised, parallel-group study evaluating safety, tolerability and pharmacokinetics (PK) of oral nintedanib incombination with oral pirfenidone, compared to treatment with nintedanib alone, in patients with idiopathic pulmonary fibrosis (IPF) - - | Idiopathic Pulmonary Fibrosis MedDRA version: 20.0;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Trade Name: Ofev INN or Proposed INN: nintedanib Other descriptive name: nintedanib Trade Name: Ofev INN or Proposed INN: Nintedanib Other descriptive name: NINTEDANIB Trade Name: Esbriet INN or Proposed INN: PIRFENIDONE Other descriptive name: PIRFENIDONE | BOEHRINGER-INGELHEIM ITALIA S.P.A. | NULL | Not Recruiting | Female: yes Male: yes | 135 | Phase 4 | France;United States;Canada;Netherlands;Germany;Italy | ||
| 287 | EUCTR2014-004782-24-IT (EUCTR) | 22/12/2015 | 06/09/2021 | A study to test intravenous PRM-151 for safety and to see how PRM-151 acts in the body and blood of people with idiopathic pulmonary fibrosis (IPF) - a disorder where lung tissue becomes damaged and scarred making it difficult to breathe. | A Phase 2 Trial to Evaluate the Efficacy of PRM-151 in Subjects with Idiopathic Pulmonary Fibrosis (IPF) - PRM-151-202 | Idiopathic Pulmonary Fibrosis (IPF) MedDRA version: 21.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Body processes [G] - Circulatory and Respiratory Physiological Phenomena [G09] | Product Code: PRM-151 | PROMEDIOR, INC. | NULL | Not Recruiting | Female: yes Male: yes | 117 | Phase 2 | France;United States;Czechia;Hungary;Czech Republic;Spain;Belgium;Netherlands;Germany;United Kingdom;Italy | ||
| 288 | EUCTR2015-003280-11-IT (EUCTR) | 17/12/2015 | 27/05/2021 | A Study of the Safety and Tolerability of Pirfenidone (Esbriet) in Combination with Nintedanib (Ofev) in Patients with Idiopathic Pulmonary Fibrosis | AN EXPLORATORY MULTICENTER, OPEN-LABEL, SINGLE ARM STUDY OF THE SAFETY AND TOLERABILITY OF PIRFENIDONE (ESBRIET¿) IN COMBINATION WITH NINTEDANIB (OFEV¿) IN PATIENTS WITH IDIOPATHIC PULMONARY FIBROSIS - NA | Idiopathic Pulmonary Fibrosis (IPF) MedDRA version: 21.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Trade Name: ESBRIET - 267 MG - CAPSULA RIGIDA - USO ORALE - FLACONE (HDPE) 270 CAPSULE Product Name: Esbriet Product Code: RO0220912 INN or Proposed INN: PIRFENIDONE Trade Name: Ofev INN or Proposed INN: NINTEDANIB Trade Name: Ofev INN or Proposed INN: NINTEDANIB | F. HOFFMANN - LA ROCHE LTD. | NULL | Not Recruiting | Female: yes Male: yes | 80 | Phase 4 | France;United States;Canada;Spain;Denmark;Netherlands;Germany;Italy | ||
| 289 | EUCTR2015-003280-11-ES (EUCTR) | 16/12/2015 | 30/10/2015 | A Study of the Safety and Tolerability of Pirfenidone (Esbriet) in Combination with Nintedanib (Ofev) in Patients with Idiopathic Pulmonary Fibrosis | AN EXPLORATORY MULTICENTER, OPEN-LABEL, SINGLE ARM STUDY OF THE SAFETY AND TOLERABILITY OF PIRFENIDONE (ESBRIET®) IN COMBINATION WITH NINTEDANIB (OFEV®) IN PATIENTS WITH IDIOPATHIC PULMONARY FIBROSIS | Idiopathic Pulmonary Fibrosis (IPF) MedDRA version: 18.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Trade Name: Esbriet Product Name: Esbriet Product Code: RO0220912 INN or Proposed INN: PIRFENIDONE Trade Name: Ofev Product Name: Ofev Product Code: 534-1508 INN or Proposed INN: NINTEDANIB Trade Name: Ofev Product Name: Ofev Product Code: 534-1508 INN or Proposed INN: NINTEDANIB | Roche Farma S.A., que representa en España a F. Hoffmann-La Roche Ltd | NULL | Not Recruiting | Female: yes Male: yes | 80 | Phase 4 | France;United States;Canada;Spain;Denmark;Netherlands;Germany;Italy | ||
| 290 | NCT02612051 (ClinicalTrials.gov) | December 4, 2015 | 19/11/2015 | First Time in Human (FTIH) Study of GSK3008348 in Healthy Volunteers and Idiopathic Pulmonary Fibrosis Patients | A FTIH Study With GSK3008348 in Healthy Volunteers and Patients With Idiopathic Pulmonary Fibrosis | Idiopathic Pulmonary Fibrosis | Drug: GSK3008348 Nebuliser solution;Drug: Placebo Nebuliser solution;Radiation: GSK26346763: ([18F]-FBA-A20FMDV2) IV infusion | GlaxoSmithKline | NULL | Completed | 18 Years | N/A | All | 40 | Phase 1 | United Kingdom |
| 291 | EUCTR2014-000861-32-DE (EUCTR) | 01/12/2015 | 02/09/2015 | Standard-armed controlled study to assess the impact of oral Pirfenidone for progressive, non-IPF Lung Fibrosis (RELIEF) | Exploring Efficacy and Safety of oral Pirfenidone for progressive, non-IPF Lung Fibrosis (RELIEF)A randomized, double-blind, placebo-controlled, parallel group, multi-center, phase II trial - RELIEF | 1.Fibrotic NSIP., 2.Chronic Hypersensitivity Pneumonitis 3. Lung fibrosis associated with collagen / vascular diseases, 4.Asbestos-induced lung fibrosis MedDRA version: 20.0;Level: LLT;Classification code 10022612;Term: Interstitial lung fibrosis;System Organ Class: 100000004855 MedDRA version: 20.0;Classification code 10035754;Term: Pneumonitis hypersensitivity;Classification code 10025088;Term: Lung fibrosis;Classification code 10022617;Term: Interstitial pneumonia;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Trade Name: Esbriet® (Pirfenidon) Product Name: Esbriet® (Pirfenidon) Product Code: PZN 8881655(RochePharma AG) INN or Proposed INN: PIRFENIDONE | Justus Liebig Universität Giessen | NULL | Not Recruiting | Female: yes Male: yes | 374 | Phase 2 | Germany | ||
| 292 | EUCTR2015-000640-42-DE (EUCTR) | 01/12/2015 | 03/09/2015 | Safety, tolerability and PK of nintedanib in combination with pirfenidone in IPF | A twelve week, open-label, randomised, parallel-group study evaluating safety, tolerability and pharmacokinetics (PK) of oral nintedanib in combination with oral pirfenidone, compared to treatment with nintedanib alone, in patients with idiopathic pulmonary fibrosis (IPF) - Safety, tolerability and PK of nintedanib iin combination with pirfenidone in IPF | Idiopathic Pulmonary Fibrosis MedDRA version: 19.0;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Trade Name: Ofev Product Name: Ofev 100 mg capsule Product Code: nintedanib INN or Proposed INN: nintedanib Other descriptive name: NINTEDANIB Trade Name: Ofev Product Name: Ofev 150 mg capsule Product Code: nintedanib INN or Proposed INN: nintedanib Other descriptive name: NINTEDANIB Trade Name: Esbriet Product Name: pirfenidone Product Code: pirfenidone INN or Proposed INN: PIRFENIDONE Other descriptive name: PIRFENIDONE | Boehringer Ingelheim Pharma GmbH & Co.KG | NULL | Not Recruiting | Female: yes Male: yes | 135 | Phase 4 | France;United States;Canada;Netherlands;Germany;Italy | ||
| 293 | EUCTR2015-000492-27-FR (EUCTR) | 24/11/2015 | 11/09/2015 | N/A | N/A - EXAFIP | MedDRA version: 18.0;Level: LLT;Classification code 10067761;Term: Exacerbation of idiopathic pulmonary fibrosis;System Organ Class: 100000004855 | Trade Name: ENDOXAN Product Name: ENDOXAN INN or Proposed INN: Cyclosphamine Other descriptive name: ENDOXAN Trade Name: UROMITEXAN Product Name: UROMITEXAN INN or Proposed INN: MESNA | ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP) | NULL | Not Recruiting | Female: yes Male: yes | 120 | Phase 3 | France | ||
| 294 | EUCTR2014-004782-24-BE (EUCTR) | 06/11/2015 | 27/05/2015 | A study to test intravenous PRM-151 for safety and to see how PRM-151 acts in the body and blood of people with idiopathic pulmonary fibrosis (IPF) - a disorder where lung tissue becomes damaged and scarred making it difficult to breathe. | A Phase 2 Trial to Evaluate the Efficacy of PRM-151 in Subjects with Idiopathic Pulmonary Fibrosis (IPF) | Idiopathic Pulmonary Fibrosis (IPF) MedDRA version: 18.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders ;Therapeutic area: Body processes [G] - Circulatory and Respiratory Physiological Phenomena [G09] | Product Code: PRM-151 INN or Proposed INN: PRM-151 | Promedior, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 117 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | United States;Hungary;Czech Republic;Spain;Belgium;Israel;Netherlands;Germany;Italy;United Kingdom;Switzerland | ||
| 295 | NCT02579603 (ClinicalTrials.gov) | October 16, 2015 | 16/10/2015 | Safety, Tolerability and PK of Nintedanib in Combination With Pirfenidone in IPF | A Twelve Week, Open-label, Randomised, Parallel-group Study Evaluating Safety, Tolerability and Pharmacokinetics (PK) of Oral Nintedanib in Combination With Oral Pirfenidone, Compared to Treatment With Nintedanib Alone, in Patients With Idiopathic Pulmonary Fibrosis (IPF) | Idiopathic Pulmonary Fibrosis | Drug: Nintedanib;Drug: Pirfenidone | Boehringer Ingelheim | NULL | Completed | 40 Years | N/A | All | 105 | Phase 4 | United States;Canada;France;Germany;Italy;Netherlands |
| 296 | JPRN-UMIN000019436 | 2015/10/16 | 21/10/2015 | Randomized Phase 2 study of Nintedanib and Pirfenidone versus Nintedanib following a clinically meaningful decline in forced vital capacity in patients with idiopathic pulmonary fibrosis administering pirfenidone | Randomized Phase 2 study of Nintedanib and Pirfenidone versus Nintedanib following a clinically meaningful decline in forced vital capacity in patients with idiopathic pulmonary fibrosis administering pirfenidone - Randomized Phase 2 study of Nintedanib and Pirfenidone versus Nintedanib following a clinically meaningful decline in forced vital capacity in patients with idiopathic pulmonary fibrosis administering pirfenidone | idiopathic pulmonary fibrosis | Nintedanib+pirfenidone group; Nintedanib 150mg twice daily Pirfenidone 600-1800mg/day Nintedanib group; Nintedanib 150mg twice daily | Kanagawa Cardiovascular and Respiratory Center | NULL | Complete: follow-up complete | 40years-old | Not applicable | Male and Female | 60 | Phase 2 | Japan |
| 297 | EUCTR2015-000640-42-NL (EUCTR) | 13/10/2015 | 18/08/2015 | Safety, tolerability and PK of nintedanib in combination with pirfenidone in IPF | A twelve week, open-label, randomised, parallel-group study evaluating safety, tolerability and pharmacokinetics (PK) of oral nintedanib in combination with oral pirfenidone, compared to treatment with nintedanib alone, in patients with idiopathic pulmonary fibrosis (IPF) - Safety, tolerability and PK of nintedanib iin combination with pirfenidone in IPF | Idiopathic Pulmonary Fibrosis MedDRA version: 18.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Trade Name: Ofev Product Name: Ofev 100 mg capsule Product Code: nintedanib INN or Proposed INN: nintedanib Other descriptive name: NINTEDANIB Trade Name: Ofev Product Name: Ofev 150 mg capsule Product Code: nintedanib INN or Proposed INN: nintedanib Other descriptive name: NINTEDANIB Trade Name: Esbriet Product Name: pirfenidone Product Code: pirfenidone INN or Proposed INN: PIRFENIDONE Other descriptive name: PIRFENIDONE | Boehringer Ingelheim bv | NULL | Not Recruiting | Female: yes Male: yes | 135 | Phase 4 | France;United States;Canada;Germany;Netherlands;Italy | ||
| 298 | NCT02550873 (ClinicalTrials.gov) | September 7, 2015 | 27/8/2015 | A Trial to Evaluate the Efficacy of PRM-151 in Subjects With Idiopathic Pulmonary Fibrosis (IPF) | A Phase 2 Trial to Evaluate the Efficacy of PRM-151 in Subjects With Idiopathic Pulmonary Fibrosis (IPF) | Idiopathic Pulmonary Fibrosis | Biological: PRM-151;Other: placebo | Hoffmann-La Roche | NULL | Completed | 40 Years | 80 Years | All | 117 | Phase 2 | United States;Czechia;Germany;Italy;Netherlands;Spain;Switzerland;Belgium;Czech Republic;Israel;United Kingdom |
| 299 | EUCTR2014-003933-24-DE (EUCTR) | 31/08/2015 | 02/03/2015 | Efficacy and Safety of SAR156597 in the Treatment of Idiopathic Pulmonary Fibrosis | Efficacy and Safety of SAR156597 in the Treatment of Idiopathic Pulmonary Fibrosis (IPF): A Randomized, Double-blind, Placebo-controlled, 52-week Dose-ranging Study - ESTAIR | Idiopathic pulmonary fibrosis MedDRA version: 19.0;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Code: SAR156597 | sanofi-aventis recherche & développement | NULL | Not Recruiting | Female: yes Male: yes | 300 | Phase 2 | Portugal;United States;Greece;Spain;Turkey;Israel;Chile;Colombia;Italy;United Kingdom;France;Czech Republic;Mexico;Canada;Argentina;Australia;Denmark;Germany;Korea, Republic of | ||
| 300 | NCT02502097 (ClinicalTrials.gov) | August 26, 2015 | 16/7/2015 | A Study of Gefapixant (AF-219/MK-7264) in Participants With Idiopathic Pulmonary Fibrosis (IPF) With Persistent Cough (MK-7264-016) | A Randomized Placebo-Controlled Study to Assess the Efficacy and Safety of AF-219, a P2X3 Receptor Antagonist, in Subjects With Idiopathic Pulmonary Fibrosis (IPF) With Persistent Cough | Idiopathic Pulmonary Fibrosis;Cough | Drug: Gefapixant;Other: Placebo | Afferent Pharmaceuticals, Inc. | NULL | Completed | 40 Years | N/A | All | 51 | Phase 2 | United States |
| 301 | EUCTR2015-000640-42-FR (EUCTR) | 26/08/2015 | 05/08/2015 | Safety, tolerability and PK of nintedanib in combination with pirfenidone in IPF | A twelve week, open-label, randomised, parallel-group study evaluating safety, tolerability and pharmacokinetics (PK) of oral nintedanib in combination with oral pirfenidone, compared to treatment with nintedanib alone, in patients with idiopathic pulmonary fibrosis (IPF) - Safety, tolerability and PK of nintedanib in combination with pirfenidone in IPF | Idiopathic Pulmonary Fibrosis MedDRA version: 18.0;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Trade Name: Ofev Product Name: Ofev 100 mg capsule Product Code: nintedanib INN or Proposed INN: nintedanib Other descriptive name: NINTEDANIB Trade Name: Ofev Product Name: Ofev 150 mg capsule Product Code: nintedanib INN or Proposed INN: nintedanib Other descriptive name: NINTEDANIB Trade Name: Esbriet Product Name: pirfenidone Product Code: pirfenidone INN or Proposed INN: PIRFENIDONE Other descriptive name: PIRFENIDONE | Boehringer Ingelheim France | NULL | Not Recruiting | Female: yes Male: yes | 135 | Phase 4 | United States;France;Canada;Netherlands;Germany;Italy | ||
| 302 | EUCTR2014-003933-24-GB (EUCTR) | 29/07/2015 | 05/02/2015 | Efficacy and Safety of SAR156597 in the Treatment of Idiopathic Pulmonary Fibrosis | Efficacy and Safety of SAR156597 in the Treatment of Idiopathic Pulmonary Fibrosis (IPF): A Randomized, Double-blind, Placebo-controlled, 52-week Dose-ranging Study - ESTAIR | Idiopathic pulmonary fibrosis MedDRA version: 18.0;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders ;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Code: SAR156597 | sanofi-aventis recherche & développement | NULL | Not Recruiting | Female: yes Male: yes | 300 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | Portugal;United States;Greece;Spain;Turkey;Israel;Chile;Colombia;Italy;United Kingdom;France;Czech Republic;Mexico;Canada;Argentina;Australia;Denmark;Germany;Korea, Republic of | ||
| 303 | NCT02477709 (ClinicalTrials.gov) | July 20, 2015 | 17/6/2015 | A Study to Assess the Tolerability of a Single Dose of Gefapixant (AF-219/MK-7264) in Subjects With Idiopathic Pulmonary Fibrosis (IPF) | A Study to Assess the Tolerability of a Single Dose of AF-219, a P2X3 Receptor Antagonist, in Subjects With Idiopathic Pulmonary Fibrosis (IPF) | Idiopathic Pulmonary Fibrosis | Drug: Gefapixant | Afferent Pharmaceuticals, Inc. | NULL | Completed | 40 Years | N/A | All | 6 | Phase 2 | United States |
| 304 | NCT01841307 (ClinicalTrials.gov) | July 2015 | 23/4/2013 | Cromolyn Detection of Silent Aspiration | Development and Validation of Test for Gastro-esophageal Reflux and Aspiration | Gastroesophageal Reflux;Respiratory Aspiration;Idiopathic Pulmonary Fibrosis;Lung Transplantation | Drug: Cromolyn Sodium | University of California, San Francisco | Aradign Corportation;National Heart, Lung, and Blood Institute (NHLBI) | Terminated | 18 Years | 70 Years | All | 16 | Phase 1 | United States |
| 305 | NCT02538536 (ClinicalTrials.gov) | July 2015 | 25/8/2015 | A Phase 2 Study to Evaluate the Safety and Tolerability of PBI-4050 in Patients With Idiopathic Pulmonary Fibrosis (IPF) | A Phase 2, Open-label, Single Arm, Exploratory, Observational Study to Evaluate the Safety and Tolerability of PBI-4050 in Patients With Idiopathic Pulmonary Fibrosis (IPF) | Idiopathic Pulmonary Fibrosis (IPF) | Drug: PBI4050 | Liminal BioSciences Ltd. | NULL | Completed | 40 Years | N/A | All | 41 | Phase 2 | Canada |
| 306 | EUCTR2014-003933-24-GR (EUCTR) | 14/05/2015 | 22/06/2015 | Efficacy and Safety of SAR156597 in the Treatment of Idiopathic Pulmonary Fibrosis | Efficacy and Safety of SAR156597 in the Treatment of Idiopathic Pulmonary Fibrosis (IPF): A Randomized, Double-blind, Placebo-controlled, 52-week Dose-ranging Study | Idiopathic pulmonary fibrosis MedDRA version: 18.0;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Code: SAR156597 | sanofi-aventis recherche & développement | NULL | Not Recruiting | Female: yes Male: yes | 300 | Phase 2 | Portugal;United States;Greece;Spain;Turkey;Israel;Chile;Colombia;Italy;United Kingdom;France;Czech Republic;Mexico;Canada;Argentina;Denmark;Germany;Korea, Republic of | ||
| 307 | EUCTR2014-003933-24-FR (EUCTR) | 12/05/2015 | 03/06/2015 | Efficacy and Safety of SAR156597 in the Treatment of Idiopathic Pulmonary Fibrosis | Efficacy and Safety of SAR156597 in the Treatment of Idiopathic Pulmonary Fibrosis (IPF): A Randomized, Double-blind, Placebo-controlled, 52-week Dose-ranging Study | Idiopathic pulmonary fibrosis MedDRA version: 18.0;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Code: SAR156597 | sanofi-aventis recherche & développement | NULL | Not Recruiting | Female: yes Male: yes | 300 | Phase 2 | Portugal;United States;Greece;Spain;Turkey;Chile;Israel;Colombia;United Kingdom;Italy;France;Czech Republic;Mexico;Canada;Argentina;Denmark;Germany;Korea, Republic of | ||
| 308 | EUCTR2014-003933-24-IT (EUCTR) | 06/05/2015 | 27/05/2021 | Efficacy and Safety of SAR156597 in the Treatment of Idiopathic Pulmonary Fibrosis | Efficacy and Safety of SAR156597 in the Treatment of Idiopathic Pulmonary Fibrosis (IPF): A Randomized, Double-blind, Placebo-controlled, 52-week Dose-ranging Study - DRI11772 | Idiopathic pulmonary fibrosis MedDRA version: 21.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: SAR156597 | SANOFI-AVENTIS RECHERCHE E DEVELOPPEMENT | NULL | Not Recruiting | Female: yes Male: yes | 300 | Phase 2 | Portugal;France;Czech Republic;Greece;Spain;Denmark;Germany;United Kingdom;Italy | ||
| 309 | EUCTR2014-004782-24-NL (EUCTR) | 06/05/2015 | 08/12/2014 | A study to test intravenous PRM-151 for safety and to see how PRM-151 acts in the body and blood of people with idiopathic pulmonary fibrosis (IPF) - a disorder where lung tissue becomes damaged and scarred making it difficult to breathe. | A Pilot Trial to Evaluate the Efficacy of PRM-151 in Subjects with Idiopathic Pulmonary Fibrosis (IPF). | Idiopathic Pulmonary Fibrosis (IPF) MedDRA version: 17.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Body processes [G] - Circulatory and Respiratory Physiological Phenomena [G09] | Product Code: PRM-151 | Promedior inc | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 60 | Netherlands | |||
| 310 | NCT02345070 (ClinicalTrials.gov) | May 1, 2015 | 19/1/2015 | Efficacy and Safety of SAR156597 in the Treatment of Idiopathic Pulmonary Fibrosis | Efficacy and Safety of SAR156597 in the Treatment of Idiopathic Pulmonary Fibrosis (IPF): A Randomized, Double-blind, Placebo-controlled, 52-week Dose-ranging Study | Idiopathic Pulmonary Fibrosis | Drug: SAR156597;Drug: placebo | Sanofi | NULL | Completed | 40 Years | N/A | All | 327 | Phase 2 | United States;Argentina;Australia;Canada;Chile;Colombia;Czechia;Denmark;France;Germany;Greece;Israel;Italy;Korea, Republic of;Mexico;Portugal;Spain;Turkey;United Kingdom;Czech Republic |
| 311 | NCT02478268 (ClinicalTrials.gov) | May 2015 | 16/6/2015 | Using MRI to Visualize Regional Therapy Response in Idiopathic Pulmonary Fibrosis | Using MRI to Visualize Regional Therapy Response in Idiopathic Pulmonary Fibrosis | Idiopathic Pulmonary Fibrosis | Drug: Hyperpolarized 129-Xenon gas;Device: MRI | Bastiaan Driehuys | University of Wisconsin, Madison;National Heart, Lung, and Blood Institute (NHLBI) | Completed | 18 Years | N/A | All | 64 | Phase 1 | United States |
| 312 | NCT02267655 (ClinicalTrials.gov) | May 2015 | 7/10/2014 | 3 Part Study to Assess Inhaled Nitric Oxide on Functional Pulmonary Imaging in Subj. Pulmonary Hypertension Associated w/ COPD and IPF | An Exploratory, 3-Part, Clinical Study to Assess the Effect of Pulsed, Inhaled Nitric Oxide (iNO) on Functional Pulmonary Imaging Parameters in Subjects With World Health Organization (WHO) Group 3 Pulmonary Hypertension (PH) Associated With Chronic Obstructive Pulmonary Disease (COPD) on Long-Term Oxygen Therapy (LTOT) (Part 1) and in Subjects With WHO Group 3 PH Associated With Idiopathic Pulmonary Fibrosis (IPF) on LTOT (Part 2 and Part 3) | Pulmonary Hypertension;Chronic Obstructive Pulmonary Disease;Idiopathic Pulmonary Fibrosis | Drug: inhaled Nitric Oxide - 30 mcg/kg IBW/hr;Drug: inhaled Nitric Oxide 5,10,15 mcg/Kg IBW/hr;Drug: inhaled nitric oxide 75 mcg/kg IBW/hr | Bellerophon | NULL | Completed | 40 Years | 80 Years | All | 8 | Phase 1 | Belgium |
| 313 | EUCTR2014-003933-24-ES (EUCTR) | 30/04/2015 | 03/03/2015 | Efficacy and Safety of SAR156597 in the Treatment of Idiopathic Pulmonary Fibrosis | Efficacy and Safety of SAR156597 in the Treatment of Idiopathic Pulmonary Fibrosis (IPF): A Randomized, Double-blind, Placebo-controlled, 52-week Dose-ranging Study | Idiopathic pulmonary fibrosis MedDRA version: 18.0;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Code: SAR156597 INN or Proposed INN: NA | sanofi-aventis recherche & développement | NULL | Not Recruiting | Female: yes Male: yes | 300 | Phase 2 | United Kingdom;France;Czech Republic;Mexico;Canada;Argentina;Denmark;Germany;Korea, Republic of;Portugal;United States;Greece;Spain;Turkey;Israel;Chile;Colombia;Italy | ||
| 314 | EUCTR2014-003933-24-CZ (EUCTR) | 10/04/2015 | 13/02/2015 | Efficacy and Safety of SAR156597 in the Treatment of Idiopathic Pulmonary Fibrosis | Efficacy and Safety of SAR156597 in the Treatment of Idiopathic Pulmonary Fibrosis (IPF): A Randomized, Double-blind, Placebo-controlled, 52-week Dose-ranging Study - ESTAIR | Idiopathic pulmonary fibrosis MedDRA version: 18.0;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Code: SAR156597 | sanofi-aventis recherche & développement | NULL | Not Recruiting | Female: yes Male: yes | 300 | Phase 2 | United States;Portugal;Greece;Spain;Turkey;Chile;Israel;Colombia;United Kingdom;Italy;France;Czech Republic;Mexico;Canada;Argentina;Australia;Denmark;Germany;Korea, Republic of | ||
| 315 | EUCTR2014-003933-24-DK (EUCTR) | 07/04/2015 | 20/02/2015 | Efficacy and Safety of SAR156597 in the Treatment of Idiopathic Pulmonary Fibrosis | Efficacy and Safety of SAR156597 in the Treatment of Idiopathic Pulmonary Fibrosis (IPF): A Randomized, Double-blind, Placebo-controlled, 52-week Dose-ranging Study - ESTAIR | Idiopathic pulmonary fibrosis MedDRA version: 18.0;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: SAR156597 Product Code: SAR156597 INN or Proposed INN: SAR156597 | sanofi-aventis recherche & développement | NULL | Not Recruiting | Female: yes Male: yes | 300 | Phase 2 | Portugal;United States;Greece;Spain;Turkey;Israel;Chile;Colombia;Italy;United Kingdom;France;Czech Republic;Mexico;Canada;Argentina;Denmark;Australia;Germany;Korea, Republic of | ||
| 316 | JPRN-UMIN000016826 | 2015/03/31 | 31/03/2015 | The evaluation of oxidative stress and the effect of pirfenidone in patients with idiopathic pulmonary fibrosis. | The evaluation of oxidative stress and the effect of pirfenidone in patients with idiopathic pulmonary fibrosis. - The evaluation of oxidative stress and the effect of pirfenidone in patients with idiopathic pulmonary fibrosis. | Idiopathic pulmonary fibrosis (IPF) | Pirfenidone Observation | National Hospital Organization Ibarakihigashi National Hospital | NULL | Complete: follow-up complete | Not applicable | Not applicable | Male and Female | 40 | Not applicable | Japan |
| 317 | NCT02397005 (ClinicalTrials.gov) | March 2015 | 27/2/2015 | Study of the Tolerability and Pharmacokinetic of ZL-2102 With an Investigation of Food Effect in Healthy Male Subjects | Randomized, Double-blind, Placebo-controlled Study of the Tolerability and Pharmacokinetics of Ascending Single and 14-day Repeated Oral Doses of ZL-2102 With a Pilot Investigation of Food Effect in Healthy Male Subjects | Chronic Obstructive Pulmonary Disease;Asthma;Idiopathic Pulmonary Fibrosis | Drug: ZL-2102;Drug: Placebo matching ZL-2102 | Zai Lab Pty. Ltd. | NULL | Active, not recruiting | 18 Years | 45 Years | Male | 120 | Phase 1 | Australia |
| 318 | EUCTR2014-004025-40-NL (EUCTR) | 06/02/2015 | 11/12/2014 | Treatment of chronic cough with PA101. | Treatment of Chronic Idiopathic Cough (CIC) and Chronic Cough in patients with Idiopathic Pulmonary Fibrosis (IPF) with PA101. - Treatment of chronic cough with PA101 | Chronic Idiopathic Cough and Chronic Cough in Idiopathic Pulmonary Fibrosis MedDRA version: 18.0;Level: LLT;Classification code 10066656;Term: Chronic cough;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: Disodium Cromoglycate [cromolyn sodium] Product Code: PA101 INN or Proposed INN: Not available Other descriptive name: Disodium cromoglycate (DSCG) | Patara Pharma | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 48 | Netherlands;United Kingdom | |||
| 319 | NCT02412020 (ClinicalTrials.gov) | February 2015 | 3/4/2015 | Treatment of Refractory Chronic Cough With PA101 | Treatment of Chronic Idiopathic Cough and Chronic Cough in Patients With Idiopathic Pulmonary Fibrosis With PA101 | Refractory Chronic Cough | Drug: PA101;Drug: Placebo | Patara Pharma | NULL | Completed | 18 Years | 75 Years | Both | 52 | Phase 2 | Netherlands;United Kingdom |
| 320 | ChiCTR-OOC-15005862 | 2015-01-01 | 2015-01-19 | The clinical study of the treatment by Granulocyte colony stimulating factor for idiopathic pulmonary fibrosis. | An Open-label, parallel, randomized controlled clinical study of the treatment by Granulocyte colony stimulating factor for idiopathic pulmonary fibrosis. | idiopathic pulmonary fibrosis | treatment group:subcutaneous injection of Granulocyte colony stimulating factor termly;control group:no processing; | Shanghai Pulmonary Hospital | NULL | Recruiting | 50 | 80 | Both | treatment group:50;control group:50; | China | |
| 321 | JPRN-UMIN000015508 | 2015/01/01 | 24/10/2014 | A prospective randomized, multicenter trial evaluating the efficacy and safety of combined therapy with pirfenidone and inhaled N-acetylcysteine for idiopathic pulmonary fibrosis. | A prospective randomized, multicenter trial evaluating the efficacy and safety of combined therapy with pirfenidone and inhaled N-acetylcysteine for idiopathic pulmonary fibrosis. - Combined therapy with pirfenidone and inhaled N-acetylcysteine for idiopathic pulmonary fibrosis. | Idiopathic pulmonary fibrosis | Using Micro Air nebulizers and vibration mesh technology (NE-U07, Omron, Tokyo, Japan), patients receiving NAC combined with pirfenidone were treated twice daily with 352.4 mg of inhaled NAC, which was diluted with saline to a total volume of 6 mL for 48 weeks. Pirfenidone 1200-1800mg (control group) | Grant for Research on Diffuse Lung Disease from the Ministry of Health, Labour and Welfare of Japan. | NULL | Complete: follow-up complete | 40years-old | Not applicable | Male and Female | 150 | Not selected | Japan |
| 322 | ChiCTR-OOC-15005841 | 2015-01-01 | 2015-01-17 | Montelukast Sodium Tablets treatment clinical study for intractable cough by idiopathic pulmonary fibrosis | Montelukast Sodium Tablets treatment clinical study for intractable cough by idiopathic pulmonary fibrosis | Idiopathic pulmonary fibrosis | Montelukast Sodium Tablets treatment group :Montelukast Sodium Tablets: oral, 1 tablets each time (10mg), 1 time a day, at bedtime, for a period of 12 weeks;control group :Don't take Montelukast Sodium Tablets; | Shanghai Pulmonary Hospital | NULL | Recruiting | 50 | 80 | Both | Montelukast Sodium Tablets treatment group :30;control group :30; | NULL | |
| 323 | NCT02485886 (ClinicalTrials.gov) | January 2015 | 26/6/2015 | 68Ga-BMV101 PET/CT in Patients With Idiopathic Pulmonary Fibrosis | Safety and Diagnostic Performance of 68Ga-BMV101 PET/CT in Patients With Idiopathic Pulmonary Fibrosis | Idiopathic Pulmonary Fibrosis | Drug: 68Ga-BMV101 | Peking Union Medical College Hospital | Stanford University | Unknown status | 18 Years | N/A | All | 20 | Early Phase 1 | China |
| 324 | EUCTR2014-004058-32-GB (EUCTR) | 19/12/2014 | 12/06/2015 | Treating pulmonary fibrosis with co-trimoxazole | The Efficacy and Mechanism Evaluation of Treating Idiopathic Pulmonary Fibrosis with the Addition of Co-trimoxazole (EME-TIPAC) - Treating pulmonary fibrosis with co-trimoxazole | Idiopathic Pulmonary Fibrosis MedDRA version: 18.0;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Trade Name: Cotrimoxazole Product Name: Cotrimoxazole Product Code: NA INN or Proposed INN: trimethoprim Other descriptive name: none INN or Proposed INN: sulphamethoxazole Other descriptive name: none | Norfolk and Norwich University Hospital NHS Foundation Trust | NULL | Not Recruiting | Female: yes Male: yes | 330 | Phase 3 | United Kingdom | ||
| 325 | EUCTR2014-004025-40-GB (EUCTR) | 09/12/2014 | 06/01/2015 | Treatment of chronic cough with PA101. | Treatment of Chronic Idiopathic Cough (CIC) and Chronic Cough in patients with Idiopathic Pulmonary Fibrosis (IPF) with PA101. - Treatment of chronic cough with PA101 | Chronic Idiopathic Cough and Chronic Cough in Idiopathic Pulmonary Fibrosis MedDRA version: 18.0;Level: LLT;Classification code 10066656;Term: Chronic cough;System Organ Class: 100000004855 ;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: Disodium Cromoglycate [cromolyn sodium] Product Code: PA101 Other descriptive name: Disodium cromoglycate (DSCG) | Patara Pharma | NULL | Not Recruiting | Female: yes Male: yes | 48 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | Netherlands;United Kingdom | ||
| 326 | JPRN-JapicCTI-142708 | 24/10/2014 | 14/11/2014 | A phase II study of Lebrikizumab | A PHASE II, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, STUDY TO ASSESS THE EFFICACY AND SAFETY OF LEBRIKIZUMAB IN PATIENTS WITH IDIOPATHIC PULMONARY | IDIOPATHIC PULMONARY FIBROSIS | Intervention name : RO5490255 INN of the intervention : Lebrikizumab Dosage And administration of the intervention : 250mg SC injection every 4 weeks Control intervention name : Placebo Dosage And administration of the control intervention : SC injection every 4 weeks | Chugai Pharmaceutical Co., Ltd. | NULL | 40 | BOTH | 480 | Phase 2 | NULL | ||
| 327 | NCT04016168 (ClinicalTrials.gov) | October 22, 2014 | 8/7/2019 | Idiopathic Pulmonary Fibrosis and Serum Bank | Idiopathic Pulmonary Fibrosis and Serum Bank | Idiopathic Pulmonary Fibrosis;Lung Diseases, Interstitial | Biological: Blood sample collection | Rennes University Hospital | NULL | Recruiting | 18 Years | N/A | All | 500 | France | |
| 328 | EUCTR2014-000963-42-DE (EUCTR) | 01/10/2014 | 13/08/2014 | A phase II study to assess vismodegib in the treatment of idiopathic pulmonary fibrosis | A randomized, double-blind, placebo-controlled, phase II study to assess the efficacy and safety of oral vismodegib for the treatment of idiopathic pulmonary fibrosis - ISLAND | Idiopathic pulmonary fibrosis MedDRA version: 17.0;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Trade Name: Erivedge INN or Proposed INN: vismodegib Other descriptive name: VISMODEGIB | F. Hoffmann-La Roche Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 129 | Phase 2 | United States;France;Mexico;Spain;Peru;Australia;Israel;Chile;Germany;New Zealand;Italy;Korea, Republic of | ||
| 329 | EUCTR2014-003423-21-BE (EUCTR) | 29/09/2014 | 29/08/2014 | Evaluation of impact of inhaled nitric oxide on pulmonary vessel blood volume measured by high resolution computed tomography (HRCT) in subjects with World Health Organization (WHO) Group 3 Pulmonary Hypertension (PH) Associated with Chronic Obstructive Pulmonary Disease (COPD) on Long-Term Oxygen Therapy (LTOT) (Part 1) and in subjects with WHO Group 3 Pulmonary Hypertension (PH) Associated with Idiopathic pulmonary fibrosis (IPF) on Long-Term Oxygen Therapy (LTOT) (Part 2). | An Exploratory, Two-Part, Clinical Study to Assess the Effect of Pulsed, Inhaled Nitric Oxide (iNO) on Functional Pulmonary Imaging Parameters in Subjects with World Health Organization (WHO) Group 3 Pulmonary Hypertension (PH) Associated with Chronic Obstructive Pulmonary Disease (COPD) on Long-Term Oxygen Therapy (LTOT) (Part 1) and in Subjects with WHO Group 3 PH associated with Idiopathic pulmonary fibrosis (IPF) on LTOT (Part 2). | Part 1: Pulmonary Hypertension (PH) Associated with Chronic Obstructive Pulmonary Disease (COPD) Part 2: Pulmonary Hypertension (PH) Associated with Idiopathic pulmonary fibrosis (IPF) MedDRA version: 18.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders MedDRA version: 18.1;Level: LLT;Classification code 10010952;Term: COPD;Classification code 10009033;Term: Chronic obstructive pulmonary disease;Classification code 10037400;Term: Pulmonary hypertension;Level: HLT;Classification code 10037401;Term: Pulmonary hypertensions;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Trade Name: INOmax 400ppm mol/mol inhalation gas Product Name: INO INN or Proposed INN: NITRIC OXIDE | Bellerophon Pulse Technologies LLC | NULL | Not Recruiting | Female: yes Male: yes | Phase 1;Phase 2 | Belgium | |||
| 330 | NCT02257177 (ClinicalTrials.gov) | September 2014 | 29/9/2014 | RCT (Randomized Control Trial) of TD139 vs Placebo in HV's (Human Volunteers) and IPF Patients | A Placebo-controlled RCT in HV's Investigating the Safety, Tolerability and PK (Pharmacokinetic) of TD139, a Galectin-3 Inhibitor, Followed by an Expansion Cohort Treating Subjects With Idiopathic Pulmonary Fibrosis (IPF) | Idiopathic Pulmonary Fibrosis | Drug: Inhaled TD139;Drug: Placebo | Galecto Biotech AB | NULL | Completed | 45 Years | 85 Years | All | 60 | Phase 1/Phase 2 | United Kingdom |
| 331 | NCT02173145 (ClinicalTrials.gov) | August 19, 2014 | 23/6/2014 | Azithromycin in Idiopathic Pulmonary Fibrosis | Azithromycin for the Treatment of Cough in Idiopathic Pulmonary Fibrosis- a Clinical Trial | Idiopathic Pulmonary Fibrosis;Cough | Drug: azithromycin;Drug: placebo | University Hospital Inselspital, Berne | University of Bern | Completed | 18 Years | N/A | All | 27 | N/A | Switzerland |
| 332 | NCT02135380 (ClinicalTrials.gov) | August 2014 | 8/5/2014 | Evaluate Safety and Efficacy of Intravenous Autologous ADMSc for Treatment of Idiopathic Pulmonary Fibrosis | A Prospective, Multicentric, Phase I/II, Open Label, Randomized, Interventional Study to Evaluate the Safety and Efficacy of Intravenous Autologous Adipose Derived Adult Stem Cells for Treatment of Idiopathic Pulmonary Fibrosis (IPF). | Idiopathic Pulmonary Fibrosis | Biological: Autologous Stromal Vascular Fraction (SVF);Biological: Autologous Adipose Derived MSCs (ADMSCs);Other: Control | Kasiak Research Pvt. Ltd. | NULL | Recruiting | 30 Years | 70 Years | Both | 60 | Phase 1/Phase 2 | India |
| 333 | NCT02622477 (ClinicalTrials.gov) | June 2014 | 2/12/2015 | Clinical Progression of Mild to Moderate Idiopathic Pulmonary Fibrosis (IPF) Under a Therapy With Esbriet® (Pirfenidone) | Clinical Course of Treatment With ESBRIET in Patients With Mild to Moderate IPF | Idiopathic Pulmonary Fibrosis | Drug: Pirfenidone | Hoffmann-La Roche | InterMune Deutschland GmbH | Completed | N/A | N/A | All | 12 | N/A | Germany |
| 334 | EUCTR2013-004404-19-GB (EUCTR) | 07/05/2014 | 25/03/2014 | Effect of Fostair® on biomarkers of platelet adhesion in Idiopathic pulmonary fibrosis | A Randomized, Double-blind, Placebo-controlled, Crossover Study toAssess the Effect of 28 Day Treatment with Fostair® pMDI 200/12 on biomarkers of platelet adhesion in Patients with Idiopathic pulmonary fibrosis. - Effect of Fostair® pMDI on biomarkers of platelet adhesion in IPF | Idiopathic pulmonary fibrosis MedDRA version: 16.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Trade Name: Fostair INN or Proposed INN: beclometasone dipropionate INN or Proposed INN: formoterol fumarate dihydrate | Hull and East Yorkshire Hospitals NHS Trust | NULL | Not Recruiting | Female: yes Male: yes | United Kingdom | ||||
| 335 | NCT02036970 (ClinicalTrials.gov) | May 2014 | 13/1/2014 | Bardoxolone Methyl Evaluation in Patients With Pulmonary Hypertension (PH) - LARIAT | A Dose-Ranging Study of the Efficacy and Safety of Bardoxolone Methyl in Patients With Pulmonary Hypertension | Pulmonary Arterial Hypertension;Pulmonary Hypertension;Interstitial Lung Disease;Idiopathic Interstitial Pneumonia;Idiopathic Pulmonary Fibrosis;Sarcoidosis;Respiratory Bronchiolitis Associated Interstitial Lung Disease;Desquamative Interstitial Pneumonia;Cryptogenic Organizing Pneumonia;Acute Interstitial Pneumonitis;Idiopathic Lymphoid Interstitial Pneumonia;Idiopathic Pleuroparenchymal Fibroelastosis | Drug: Bardoxolone methyl;Drug: Placebo | Reata Pharmaceuticals, Inc. | NULL | Completed | 18 Years | 75 Years | All | 166 | Phase 2 | United States;Germany;Spain;United Kingdom |
| 336 | EUCTR2013-001163-24-BE (EUCTR) | 28/04/2014 | 10/02/2014 | A Study of Lebrikizumab in Patients With Idiopathic Pulmonary Fibrosis. | A PHASE II, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, STUDY TO ASSESS THE EFFICACY AND SAFETY OF LEBRIKIZUMAB IN PATIENTS WITH IDIOPATHIC PULMONARY FIBROSIS. | IDIOPATHIC PULMONARY FIBROSIS;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: lebrikizumab Product Code: RO5490255/F01-02 INN or Proposed INN: LEBRIKIZUMAB Other descriptive name: TNX-650, rhuMAb anti-IL13, aIL-13, MILR1444A Trade Name: ESBRIET INN or Proposed INN: PIRFENIDONE | F. Hoffmann-La Roche Ltd | NULL | Not Recruiting | Female: yes Male: yes | 480 | Phase 2 | United States;Spain;United Kingdom;Italy;France;Mexico;Canada;Belgium;Poland;Australia;Peru;Germany;Japan | ||
| 337 | NCT02085018 (ClinicalTrials.gov) | March 28, 2014 | 9/2/2014 | Pilot Trial Of Omeprazole in Idiopathic Pulmonary Fibrosis (IPF) | A Randomised, Placebo-controlled Trial of Omeprazole in Idiopathic Pulmonary Fibrosis (IPF) | Idiopathic Pulmonary Fibrosis | Drug: Omeprazole;Drug: Matched placebo | Newcastle-upon-Tyne Hospitals NHS Trust | Newcastle University | Completed | 40 Years | 85 Years | All | 45 | Phase 2 | United Kingdom |
| 338 | NCT02048644 (ClinicalTrials.gov) | March 2014 | 23/1/2014 | Effect of Fostair® on Biomarkers of Platelet Adhesion in Idiopathic Pulmonary Fibrosis | A Randomized, Double-blind, Placebo-controlled, Crossover Study to Assess the Effect of 28 Day Treatment With Fostair® Pressurized Metered-dose Inhaler (pMDI) 200/12 on Biomarkers of Platelet Adhesion in Patients With Idiopathic Pulmonary Fibrosis | Idiopathic Pulmonary Fibrosis | Drug: fostair;Drug: placebo | Hull University Teaching Hospitals NHS Trust | Chiesi Farmaceutici S.p.A. | Completed | 40 Years | 85 Years | All | 20 | Phase 2 | United Kingdom |
| 339 | NCT02055456 (ClinicalTrials.gov) | February 2014 | 3/2/2014 | Nandrolone Decanoate in the Treatment of Telomeropathies | Male Hormones for Telomere Related Diseases | Aplastic Anemia;Bone Marrow Failure Syndromes;Idiopathic Pulmonary Fibrosis;Telomere Shortening | Drug: Nandrolone Decanoate | University of Sao Paulo | Conselho Nacional de Desenvolvimento Científico e Tecnológico | Recruiting | 2 Years | N/A | Both | 20 | Phase 1/Phase 2 | Brazil |
| 340 | NCT01969409 (ClinicalTrials.gov) | January 2014 | 17/10/2013 | Autoantibody Reduction Therapy in Patients With Idiopathic Pulmonary Fibrosis | Autoantibody Reduction Therapy in Patients With Idiopathic Pulmonary Fibrosis (ART-IPF) | Ambulatory IPF | Drug: Rituximab;Drug: Placebo | University of Alabama at Birmingham | National Institutes of Health (NIH) | Completed | 50 Years | 85 Years | All | 58 | Phase 2 | United States |
| 341 | NCT02036580 (ClinicalTrials.gov) | January 2014 | 13/1/2014 | D2212C00002 J-Phase II Study | A Phase 2, Multicenter, Double-Blind Within Cohort, Dose-escalation Study to Evaluate the Safety and Tolerability of Multiple Doses of CAT-354 (Tralokinumab) in Japanese Patients With Idiopathic Pulmonary Fibrosis | Idiopathic Pulmonary Fibrosis | Biological: tralokinumab cohort 1;Biological: tralokinumab cohort 2;Other: Placebo | AstraZeneca | MedImmune LLC | Completed | 50 Years | N/A | All | 37 | Phase 2 | Japan |
| 342 | NCT01979952 (ClinicalTrials.gov) | November 26, 2013 | 4/11/2013 | Nintedanib Twice Daily vs Placebo in Patients Diagnosed With Idiopathic Pulmonary Fibrosis (IPF) | A Six Month Double Blind Randomized Placebo Controlled Trial Followed by Each Arm Being Converted to Oral Nintedanib 150 mg Twice Daily Comparing the Effect on High Resolution Computerized Tomography Quantitative Lung Fibrosis Score, Lung Function, Six Minute Walk Test Distance and St. George's Respiratory Questionnaire After Six Months of Treatment in Patients With Idiopathic Pulmonary Fibrosis With Continued Evaluations Over a Period of up to Eighteen Months | Idiopathic Pulmonary Fibrosis | Drug: Matching Placebo;Drug: Nintedanib | Boehringer Ingelheim | NULL | Completed | 40 Years | N/A | All | 113 | Phase 3 | United States;Canada;Turkey |
| 343 | NCT01777737 (ClinicalTrials.gov) | November 25, 2013 | 25/1/2013 | Study to Test the Validity of the Treatment of Idiopathic Pulmonary Fibrosis With Cotrimoxazole | Pilot Study Phase III to Evaluate the Efficacy and Safety of Trimethoprim-sulfamethoxazole in the Treatment of Idiopathic Pulmonary Fibrosis | Idiopathic Pulmonary Fibrosis | Drug: Cotrimoxazole;Drug: Placebo | Fundación Pública Andaluza para la gestión de la Investigación en Sevilla | Junta de Andalucia | Terminated | 18 Years | 80 Years | All | 3 | Phase 3 | Spain |
| 344 | EUCTR2013-001163-24-IT (EUCTR) | 19/11/2013 | 05/09/2013 | A PHASE II, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, STUDY TO ASSESS THE EFFICACY AND SAFETY OF LEBRIKIZUMAB IN PATIENTS WITH IDIOPATHIC PULMONARY FIBROSIS. | A PHASE II, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, STUDY TO ASSESS THE EFFICACY AND SAFETY OF LEBRIKIZUMAB IN PATIENTS WITH IDIOPATHIC PULMONARY FIBROSIS. | IDIOPATHIC PULMONARY FIBROSIS;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: lebrikizumab Product Code: RO5490255/F01-02 INN or Proposed INN: LEBRIKIZUMAB Other descriptive name: TNX-650, rhuMAb anti-IL13, aIL-13, MILR1444A | F. Hoffmann-La Roche Ltd | NULL | Not Recruiting | Female: yes Male: yes | 250 | Phase 2 | United States;Spain;Italy;United Kingdom;France;Mexico;Canada;Poland;Belgium;Australia;Peru;Germany;Japan | ||
| 345 | NCT02013700 (ClinicalTrials.gov) | November 13, 2013 | 2/12/2013 | Allogeneic Human Cells (hMSC)in Patients With Idiopathic Pulmonary Fibrosis Via Intravenous Delivery (AETHER) | A Phase I, Randomized, Blinded and Placebo-controlled Trial to Evaluate the Safety, Tolerability, and Potential Efficacy of Allogeneic Human Mesenchymal Stem Cell Infusion in Patients With Idiopathic Pulmonary Fibrosis | Idiopathic Pulmonary Fibrosis (IPF) | Biological: Allogeneic Adult Human Mesenchymal Stem Cells (hMSCs);Biological: matched placebo | Joshua M Hare | The Lester And Sue Smith Foundation;The Emmes Company, LLC | Terminated | 40 Years | 90 Years | All | 9 | Phase 1 | United States |
| 346 | EUCTR2013-001163-24-PL (EUCTR) | 09/11/2013 | 01/10/2013 | A Study of Lebrikizumab in Patients With Idiopathic Pulmonary Fibrosis. | A PHASE II, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, STUDY TO ASSESS THE EFFICACY AND SAFETY OF LEBRIKIZUMAB IN PATIENTS WITH IDIOPATHIC PULMONARY FIBROSIS. | IDIOPATHIC PULMONARY FIBROSIS;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: lebrikizumab Product Code: RO5490255/F01-02 INN or Proposed INN: LEBRIKIZUMAB Other descriptive name: TNX-650, rhuMAb anti-IL13, aIL-13, MILR1444A Trade Name: ESBRIET INN or Proposed INN: PIRFENIDONE | F. Hoffmann-La Roche Ltd | NULL | Not Recruiting | Female: yes Male: yes | 480 | Phase 2 | United States;Spain;United Kingdom;Italy;France;Mexico;Canada;Poland;Belgium;Australia;Peru;Germany;Japan | ||
| 347 | EUCTR2013-001163-24-DE (EUCTR) | 04/11/2013 | 28/08/2013 | A Study of Lebrikizumab in Patients With Idiopathic Pulmonary Fibrosis. | A PHASE II, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, STUDY TO ASSESS THE EFFICACY AND SAFETY OF LEBRIKIZUMAB IN PATIENTS WITH IDIOPATHIC PULMONARY FIBROSIS. | IDIOPATHIC PULMONARY FIBROSIS;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: lebrikizumab Product Code: RO5490255/F01-02 INN or Proposed INN: LEBRIKIZUMAB Other descriptive name: TNX-650, rhuMAb anti-IL13, aIL-13, MILR1444A Trade Name: ESBRIET INN or Proposed INN: PIRFENIDONE | F. Hoffmann-La Roche Ltd | NULL | Not Recruiting | Female: yes Male: yes | 480 | Phase 2 | United States;Spain;United Kingdom;Italy;France;Mexico;Canada;Belgium;Poland;Australia;Peru;Germany;Japan | ||
| 348 | JPRN-UMIN000021109 | 2013/10/21 | 19/02/2016 | Preventive effect of Sivelestat Na Hydrate on postoperative acute exacerbation of idiopathic interstitial pneumonia in the patient with lung cancer | Preventive effect of Sivelestat Na Hydrate on postoperative acute exacerbation of idiopathic interstitial pneumonia in the patient with lung cancer - Preventive effect of Sivelestat Na Hydrate on postoperative acute exacerbation of idiopathic interstitial pneumonia in the patient with lung cancer (Sivelestat trial) | idiopathic interstitial pneumonia (IIP) | Control (n=30): intra- and postoperative management without Sivelestat Trial (n=30): 7days administration of Sivelestat 0.2microgram/kgBW/hr div started from surgical operation | Japanese Northern East Area Thoracic Surgery Study Group (JNETS) | NULL | Complete: follow-up complete | 25years-old | 80years-old | Male and Female | 120 | Phase 3 | Japan |
| 349 | EUCTR2013-001163-24-GB (EUCTR) | 14/10/2013 | 06/11/2013 | A Study of Lebrikizumab in Patients With Idiopathic Pulmonary Fibrosis. | A PHASE II, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, STUDY TO ASSESS THE EFFICACY AND SAFETY OF LEBRIKIZUMAB IN PATIENTS WITH IDIOPATHIC PULMONARY FIBROSIS. | IDIOPATHIC PULMONARY FIBROSIS;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: lebrikizumab Product Code: RO5490255/F01-02 INN or Proposed INN: LEBRIKIZUMAB Other descriptive name: TNX-650, rhuMAb anti-IL13, aIL-13, MILR1444A Trade Name: ESBRIET INN or Proposed INN: PIRFENIDONE | F. Hoffmann-La Roche Ltd | NULL | Not Recruiting | Female: yes Male: yes | 480 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | United States;Spain;United Kingdom;Italy;France;Mexico;Canada;Belgium;Poland;Australia;Peru;Germany;Japan | ||
| 350 | NCT01872689 (ClinicalTrials.gov) | October 13, 2013 | 5/6/2013 | A Study of Lebrikizumab in Participants With Idiopathic Pulmonary Fibrosis (IPF) | A Phase II, Randomized, Double-Blind, Placebo-Controlled, Study to Assess the Efficacy and Safety of Lebrikizumab in Patients With Idiopathic Pulmonary Fibrosis | Idiopathic Pulmonary Fibrosis | Drug: Lebrikizumab;Drug: Pirfenidone;Drug: Placebo | Hoffmann-La Roche | NULL | Completed | 40 Years | N/A | All | 505 | Phase 2 | United States;Australia;Belgium;Canada;France;Germany;Italy;Japan;Mexico;Peru;Poland;Spain;United Kingdom |
| 351 | EUCTR2013-003301-26-GB (EUCTR) | 20/09/2013 | 04/11/2013 | A clinical trial to assess whether a treatment reducing acid production in the stomach (omeprazole) can reduce cough in patients with scarring of the lungs. | A randomised placebo-controlled pilot trial of omeprazole in idiopathic pulmonary fibrosis (IPF) - Pilot trial of omeprazole in idiopathic pulmonary fibrosis (Acronym : | Idiopathic Pulmonary Fibrosis (IPF) MedDRA version: 19.0;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Trade Name: Omeprazole (UK licensed generic product) Product Name: Omeprazole INN or Proposed INN: Omeprazole | Newcastle Upon Tyne Hospitals NHS Foundation Trust | NULL | Not Recruiting | Female: yes Male: yes | Phase 2 | United Kingdom | |||
| 352 | EUCTR2013-001163-24-ES (EUCTR) | 20/09/2013 | 16/09/2013 | A Study of Lebrikizumab in Patients With Idiopathic Pulmonary Fibrosis. | A PHASE II, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, STUDY TO ASSESS THE EFFICACY AND SAFETY OF LEBRIKIZUMAB IN PATIENTS WITH IDIOPATHIC PULMONARY FIBROSIS. | IDIOPATHIC PULMONARY FIBROSIS;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: lebrikizumab Product Code: RO5490255/F01-02 INN or Proposed INN: LEBRIKIZUMAB Other descriptive name: TNX-650, rhuMAb anti-IL13, aIL-13, MILR1444A | F. Hoffmann-La Roche Ltd | NULL | Not Recruiting | Female: yes Male: yes | 250 | Phase 2 | United States;Spain;United Kingdom;Italy;France;Mexico;Canada;Poland;Belgium;Peru;Australia;Germany;Japan | ||
| 353 | EUCTR2013-001163-24-FR (EUCTR) | 17/09/2013 | 28/09/2015 | A Study of Lebrikizumab in Patients With Idiopathic Pulmonary Fibrosis. | A PHASE II, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, STUDY TO ASSESS THE EFFICACY AND SAFETY OF LEBRIKIZUMAB IN PATIENTS WITH IDIOPATHIC PULMONARY FIBROSIS. | IDIOPATHIC PULMONARY FIBROSIS;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: lebrikizumab Product Code: RO5490255/F01-02 INN or Proposed INN: LEBRIKIZUMAB Other descriptive name: TNX-650, rhuMAb anti-IL13, aIL-13, MILR1444A | F. Hoffmann-La Roche Ltd | NULL | Not Recruiting | Female: yes Male: yes | 250 | Phase 2 | United States;Spain;United Kingdom;Italy;France;Mexico;Canada;Poland;Belgium;Australia;Peru;Germany;Japan | ||
| 354 | EUCTR2012-000564-14-GB (EUCTR) | 11/09/2013 | 04/07/2013 | A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study of the Safety and Tolerability of N–Acetylcysteine in Patients with Idiopathic Pulmonary Fibrosis with Background Treatment of Pirfenidone | A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study of the Safety and Tolerability of N–Acetylcysteine in Patients with Idiopathic Pulmonary Fibrosis with Background Treatment of Pirfenidone - PANORAMA | Patients with Idiopathic Pulmonary Fibrosis (IPF) MedDRA version: 17.0;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders ;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Trade Name: Fluimucil® 600 mg effervescent tablets INN or Proposed INN: ACETYLCYSTEINE Other descriptive name: N-Acetylcysteine, (NAC) | InterMune International AG. | NULL | Not Recruiting | Female: yes Male: yes | 120 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | Belgium;Denmark;Austria;Germany;Italy;United Kingdom;Sweden | ||
| 355 | EUCTR2012-001571-36-PL (EUCTR) | 09/09/2013 | 17/06/2013 | A study to evaluate if a new drug is effective in preventing the progression of lung fibrosis | A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study to Assess the Efficacy and Safety of GS-6624 in Subjects with Idiopathic Pulmonary Fibrosis (RAINIER) - RAINIER | Idiopathic pulmonary fibrosis MedDRA version: 18.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Code: GS-6624 INN or Proposed INN: Simtuzumab Other descriptive name: GS-6624 | Gilead Sciences, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 500 | Phase 2 | United States;Czech Republic;Canada;Spain;Belgium;Poland;Australia;Israel;Germany;United Kingdom;Italy;Korea, Republic of | ||
| 356 | EUCTR2012-000564-14-DK (EUCTR) | 28/08/2013 | 12/07/2013 | A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study of the Safety and Tolerability of N–Acetylcysteine in Patients with Idiopathic Pulmonary Fibrosis with Background Treatment of Pirfenidone | A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study of the Safety and Tolerability of N–Acetylcysteine in Patients with Idiopathic Pulmonary Fibrosis with Background Treatment of Pirfenidone - PANORAMA | Patients with Idiopathic Pulmonary Fibrosis (IPF) MedDRA version: 17.0;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Trade Name: Fluimucil® 600 mg effervescent tablets INN or Proposed INN: ACETYLCYSTEINE Other descriptive name: N-Acetylcysteine, (NAC) | InterMune International AG. | NULL | Not Recruiting | Female: yes Male: yes | 120 | Phase 2 | Belgium;Austria;Denmark;Germany;United Kingdom;Italy;Sweden | ||
| 357 | NCT02707640 (ClinicalTrials.gov) | August 2013 | 9/3/2016 | A Study to Assess the Safety and Tolerability of N-Acetylcysteine When Administered With Pirfenidone to Participants With Idiopathic Pulmonary Fibrosis (IPF) | A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study of the Safety and Tolerability of N-Acetylcysteine in Patients With Idiopathic Pulmonary Fibrosis With Background Treatment of Pirfenidone | Idiopathic Pulmonary Fibrosis | Drug: Matching Placebo;Drug: N-acetylcysteine;Drug: Pirfenidone | Hoffmann-La Roche | NULL | Completed | 40 Years | 80 Years | All | 123 | Phase 2 | Austria;Belgium;Denmark;France;Germany;Italy;Sweden;United Kingdom |
| 358 | NCT01890265 (ClinicalTrials.gov) | July 30, 2013 | 24/6/2013 | Evaluate the Safety and Efficacy of FG-3019 (Pamrevlumab) in Participants With Idiopathic Pulmonary Fibrosis (IPF) | A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of FG-3019 in Patients With Idiopathic Pulmonary Fibrosis | Idiopathic Pulmonary Fibrosis | Drug: Pamrevlumab;Drug: Placebo;Drug: Sub-Study: Pirfenidone;Drug: Sub-Study: Nintedanib | FibroGen | NULL | Completed | 40 Years | 80 Years | All | 160 | Phase 2 | United States;Australia;Bulgaria;Canada;India;New Zealand;South Africa |
| 359 | EUCTR2012-000564-14-AT (EUCTR) | 19/07/2013 | 11/06/2013 | A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study of the Safety and Tolerability of N–Acetylcysteine in Patients with Idiopathic Pulmonary Fibrosis with Background Treatment of Pirfenidone | A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study of the Safety and Tolerability of N–Acetylcysteine in Patients with Idiopathic Pulmonary Fibrosis with Background Treatment of Pirfenidone - PANORAMA | Patients with Idiopathic Pulmonary Fibrosis (IPF) MedDRA version: 17.0;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Trade Name: Fluimucil® 600 mg effervescent tablets INN or Proposed INN: ACETYLCYSTEINE Other descriptive name: N-Acetylcysteine, (NAC) | InterMune International AG. | NULL | Not Recruiting | Female: yes Male: yes | 120 | Phase 2 | Belgium;Denmark;Austria;Germany;United Kingdom;Italy;Sweden | ||
| 360 | EUCTR2012-000564-14-IT (EUCTR) | 17/07/2013 | 07/06/2013 | A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study of the Safety and Tolerability of N–Acetylcysteine in Patients with Idiopathic Pulmonary Fibrosis with Background Treatment of Pirfenidone | A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study of the Safety and Tolerability of N–Acetylcysteine in Patients with Idiopathic Pulmonary Fibrosis with Background Treatment of Pirfenidone - PANORAMA | Patients with Idiopathic Pulmonary Fibrosis (IPF) MedDRA version: 16.0;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Trade Name: Fluimucil® 600 mg effervescent tablets INN or Proposed INN: ACETYLCYSTEINE Other descriptive name: N-Acetylcysteine, (NAC) | InterMune International AG. | NULL | Not Recruiting | Female: yes Male: yes | 250 | Phase 2 | Belgium;Denmark;Austria;Germany;United Kingdom;Italy;Sweden | ||
| 361 | EUCTR2012-000564-14-DE (EUCTR) | 17/07/2013 | 29/05/2013 | A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study of the Safety and Tolerability of N–Acetylcysteine in Patients with Idiopathic Pulmonary Fibrosis with Background Treatment of Pirfenidone | A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study of the Safety and Tolerability of N–Acetylcysteine in Patients with Idiopathic Pulmonary Fibrosis with Background Treatment of Pirfenidone - PANORAMA | Patients with Idiopathic Pulmonary Fibrosis (IPF) MedDRA version: 17.0;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Trade Name: Fluimucil® 600 mg effervescent tablets INN or Proposed INN: ACETYLCYSTEINE Other descriptive name: N-Acetylcysteine, (NAC) | InterMune International AG. | NULL | Not Recruiting | Female: yes Male: yes | 120 | Phase 2 | Belgium;Denmark;Austria;Germany;United Kingdom;Italy;Sweden | ||
| 362 | EUCTR2012-000564-14-SE (EUCTR) | 25/06/2013 | 24/05/2013 | A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study of the Safety and Tolerability of N–Acetylcysteine in Patients with Idiopathic Pulmonary Fibrosis with Background Treatment of Pirfenidone | A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study of the Safety and Tolerability of N–Acetylcysteine in Patients with Idiopathic Pulmonary Fibrosis with Background Treatment of Pirfenidone - PANORAMA | Patients with Idiopathic Pulmonary Fibrosis (IPF) MedDRA version: 17.0;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Trade Name: Fluimucil® 600 mg effervescent tablets INN or Proposed INN: ACETYLCYSTEINE Other descriptive name: N-Acetylcysteine, (NAC) | InterMune International AG. | NULL | Not Recruiting | Female: yes Male: yes | 120 | Phase 2 | Belgium;Denmark;Austria;Germany;United Kingdom;Italy;Sweden | ||
| 363 | EUCTR2012-000564-14-BE (EUCTR) | 18/06/2013 | 30/04/2013 | A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study of the Safety and Tolerability of N–Acetylcysteine in Patients with Idiopathic Pulmonary Fibrosis with Background Treatment of Pirfenidone | A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study of the Safety and Tolerability of N–Acetylcysteine in Patients with Idiopathic Pulmonary Fibrosis with Background Treatment of Pirfenidone - PANORAMA | Patients with Idiopathic Pulmonary Fibrosis (IPF) MedDRA version: 17.0;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Trade Name: Fluimucil® 600 mg effervescent tablets INN or Proposed INN: ACETYLCYSTEINE Other descriptive name: N-Acetylcysteine, (NAC) | InterMune International AG. | NULL | Not Recruiting | Female: yes Male: yes | 120 | Phase 2 | Belgium;Denmark;Austria;Germany;United Kingdom;Italy;Sweden | ||
| 364 | EUCTR2012-001571-36-DE (EUCTR) | 17/06/2013 | 02/04/2013 | A study to evaluate if a new drug is effective in preventing the progression of lung fibrosis | A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study to Assess the Efficacy and Safety of GS-6624 in Subjects with Idiopathic Pulmonary Fibrosis (RAINIER). - RAINIER | Idiopathic pulmonary fibrosis MedDRA version: 18.0;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Code: GS-6624 INN or Proposed INN: Simtuzumab Other descriptive name: GS-6624 | Gilead Sciences, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 500 | Phase 2 | United States;Czech Republic;Canada;Poland;Spain;Belgium;Australia;Israel;Germany;United Kingdom;Italy;Korea, Republic of | ||
| 365 | EUCTR2012-001571-36-BE (EUCTR) | 28/05/2013 | 26/03/2013 | A study to evaluate if a new drug is effective in preventing the progression of lung fibrosis | A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study to Assess the Efficacy and Safety of GS-6624 in Subjects with Idiopathic Pulmonary Fibrosis (RAINIER) - RAINIER | Idiopathic pulmonary fibrosis MedDRA version: 18.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Code: GS-6624 INN or Proposed INN: Simtuzumab Other descriptive name: GS-6624 | Gilead Sciences, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 500 | Phase 2 | Korea, Democratic People's Republic of;Israel;United Kingdom;Switzerland;Italy;France;Czech Republic;Canada;Belgium;Poland;Australia;Germany;Korea, Republic of;United States;Spain | ||
| 366 | EUCTR2012-001571-36-ES (EUCTR) | 12/05/2013 | 16/05/2013 | A study to evaluate if a new drug is effective in preventing the progression of lung fibrosis | A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study to Assess the Efficacy and Safety of GS-6624 in Subjects with Idiopathic Pulmonary Fibrosis (RAINIER) - RAINER | Idiopathic pulmonary fibrosis MedDRA version: 16.0;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Code: GS-6624 INN or Proposed INN: Simtuzumab Other descriptive name: GS-6624 | Gilead Sciences, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 500 | Phase 2 | United States;Czech Republic;Canada;Poland;Belgium;Spain;Australia;Israel;Germany;United Kingdom;Italy;Korea, Republic of | ||
| 367 | EUCTR2012-001571-36-CZ (EUCTR) | 29/04/2013 | 15/04/2013 | A study to evaluate if a new drug is effective in preventing the progression of lung fibrosis | A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study to Assess the Efficacy and Safety of GS-6624 in Subjects with Idiopathic Pulmonary Fibrosis (RAINIER). - RAINIER | Idiopathic pulmonary fibrosis MedDRA version: 18.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Code: GS-6624 INN or Proposed INN: Simtuzumab Other descriptive name: GS-6624 | Gilead Sciences, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 500 | Phase 2 | United States;Czech Republic;Canada;Poland;Spain;Belgium;Australia;Israel;Germany;United Kingdom;Italy;Korea, Republic of | ||
| 368 | EUCTR2012-001571-36-IT (EUCTR) | 26/04/2013 | 28/02/2013 | A study to evaluate if a new drug is effective in preventing the progression of lung fibrosis | A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study to Assess the Efficacy and Safety of GS-6624 in Subjects with Idiopathic Pulmonary Fibrosis (RAINIER) - RAINIER | Idiopathic pulmonary fibrosis MedDRA version: 14.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Code: GS-6624 INN or Proposed INN: Simtuzumab Other descriptive name: GS-6624 | Gilead Sciences, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 500 | Phase 2 | United States;Czech Republic;Canada;Poland;Spain;Belgium;Australia;Israel;Germany;United Kingdom;Italy;Korea, Republic of | ||
| 369 | EUCTR2011-002766-21-IE (EUCTR) | 23/04/2013 | 15/02/2013 | Long term safety study of oral BIBF 1120 in patients with Idiopathic Pulmonary Fibrosis (IPF) | An open-label extension trial of the long term safety of oral BIBF 1120 in patients with Idiopathic Pulmonary Fibrosis (IPF) | Idiopathic Pulmonary Fibrosis MedDRA version: 20.0;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: BIBF 1120 Product Code: BIBF 1120 INN or Proposed INN: nintedanib Product Name: BIBF 1120 Product Code: BIBF 1120 INN or Proposed INN: nintedanib | Boehringer Ingelheim Limited | NULL | Not Recruiting | Female: yes Male: yes | 750 | Phase 3 | United States;Portugal;Greece;Spain;Ireland;Chile;Israel;Russian Federation;Italy;India;France;Australia;Netherlands;China;Korea, Republic of;Finland;Turkey;United Kingdom;Czech Republic;Mexico;Canada;Argentina;Brazil;Belgium;Germany;Japan | ||
| 370 | EUCTR2012-005409-38-ES (EUCTR) | 19/04/2013 | 29/01/2013 | First study to test the validity of the treatment of the disease called idiopathic pulmonary fibrosis, which causes inflammation and fibrosis (scarring) of the lung tissue, with a drug called cotrimoxazole. | Pilot study phase III to evaluate the efficacy and safety of Trimethoprim-sulfamethoxazole in the treatment of idiopathic pulmonary fibrosis | Ambulatory patients, men and women, with well-established diagnosis of idiopathic pulmonary fibrosis. MedDRA version: 14.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Parasitic Diseases [C03] | Trade Name: SEPTRIN INN or Proposed INN: TRIMETHOPRIM Other descriptive name: TRIMETHOPRIM INN or Proposed INN: SULFAMETHOXAZOLE | Fundación Pública Andaluza para la Gestión de la Investigación en Salud de Sevilla (FISEVI) | NULL | Not Recruiting | Female: yes Male: yes | 56 | Phase 3 | Spain | ||
| 371 | EUCTR2012-001571-36-GB (EUCTR) | 19/04/2013 | 28/03/2013 | A study to evaluate if a new drug is effective in preventing the progression of lung fibrosis | A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study to Assess the Efficacy and Safety of GS-6624 in Subjects with Idiopathic Pulmonary Fibrosis (RAINIER) - RAINIER | Idiopathic pulmonary fibrosis MedDRA version: 17.0;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Code: GS-6624 INN or Proposed INN: Simtuzumab Other descriptive name: GS-6624 | Gilead Sciences, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 500 | Phase 2 | United States;Czech Republic;Canada;Poland;Spain;Belgium;Australia;Israel;Germany;Italy;United Kingdom;Korea, Republic of | ||
| 372 | EUCTR2012-005794-31-GB (EUCTR) | 25/03/2013 | 26/02/2013 | A study to assess the effect of a single-does of VRP700 by inhalation to reduce the frequency and severity of cough in adults with Idiopathic Pulmonary Fibrosis (IPF) | A randomised, double-blind, placebo-controlled crossover study to assess the efficacy of a single dose of 100mg of VRP700 by inhalation in reducing the frequency and severity of cough in adult patients with Idiopathic Pulmonary Fibrosis - EPOCh | Chronic cough in Idiopathic Pulmonary Fibrosis MedDRA version: 16.1;Level: LLT;Classification code 10066656;Term: Chronic cough;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders MedDRA version: 16.1;Level: PT;Classification code 10011224;Term: Cough;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: VRP700 Product Code: VRP700 | Verona Pharma plc | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | United Kingdom | ||||
| 373 | NCT01725139 (ClinicalTrials.gov) | March 8, 2013 | 8/11/2012 | A Proof of Mechanism Study With GSK2126458 in Patients With Idiopathic Pulmonary Fibrosis (IPF) | A Randomised, Placebo-controlled, Double-blind, Repeat Dose Escalation Study With GSK2126458 in Patients With Idiopathic Pulmonary Fibrosis (IPF) | Idiopathic Pulmonary Fibrosis | Drug: GSK2126458;Drug: Placebo | GlaxoSmithKline | NULL | Completed | 45 Years | N/A | All | 17 | Phase 1 | United Kingdom |
| 374 | NCT01919827 (ClinicalTrials.gov) | March 2013 | 1/8/2013 | Study of Autologous Mesenchymal Stem Cells to Treat Idiopathic Pulmonary Fibrosis | Treatment of Idiopathic Pulmonary Fibrosis With Bone Marrow Derived Mesenchymal Stem Cells | Idiopathic Pulmonary Fibrosis | Biological: Endobronchial infusion of adult mesenchymal stem cells;Biological: Autologous mesenchymal stem cells derived from bone marrow | Clinica Universidad de Navarra, Universidad de Navarra | NULL | Completed | 30 Years | 80 Years | All | 17 | Phase 1 | Spain |
| 375 | NCT02594839 (ClinicalTrials.gov) | February 2013 | 1/11/2015 | Safety and Efficacy of Allogeneic Mesenchymal Stem Cells in Patients With Rapidly Progressive Interstitial Lung Disease | A Phase I-II Study to Evaluate Safety and Efficacy of Allogeneic Bone-Marrow Mesenchymal Stem Cells in Patients With Rapidly Progressive Interstitial Lung Disease | Idiopathic Interstitial Pneumonia;Interstitial Lung Disease;Idiopathic Pulmonary Fibrosis | Drug: Bone marrow mesenchymal stem cells;Drug: Placebo | Federal Research Clinical Center of Federal Medical & Biological Agency, Russia | NULL | Completed | 20 Years | 80 Years | All | 20 | Phase 1/Phase 2 | Russian Federation |
| 376 | NCT01769196 (ClinicalTrials.gov) | January 31, 2013 | 14/1/2013 | Study to Assess the Efficacy and Safety of Simtuzumab (GS-6624) in Adults With Idiopathic Pulmonary Fibrosis (IPF) | A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study to Assess the Efficacy and Safety of Simtuzumab (GS-6624) in Subjects With Idiopathic Pulmonary Fibrosis (IPF) | Idiopathic Pulmonary Fibrosis | Drug: Simtuzumab;Drug: Simtuzumab placebo | Gilead Sciences | NULL | Terminated | 45 Years | 85 Years | All | 544 | Phase 2 | United States;Australia;Belgium;Canada;Czechia;France;Germany;Israel;Italy;Korea, Republic of;Poland;Spain;Switzerland;United Kingdom;Czech Republic |
| 377 | NCT01766817 (ClinicalTrials.gov) | January 31, 2013 | 10/1/2013 | Safety and Efficacy of a Lysophosphatidic Acid Receptor Antagonist in Idiopathic Pulmonary Fibrosis | Safety and Efficacy of a Lysophosphatidic Acid Receptor Antagonist in Idiopathic Pulmonary Fibrosis | Idiopathic Pulmonary Fibrosis | Drug: BMS-986020;Drug: Placebo matching with BMS-986020 | Bristol-Myers Squibb | NULL | Completed | 40 Years | 90 Years | All | 325 | Phase 2 | United States;Australia;Chile;Colombia;Mexico;Peru |
| 378 | JPRN-jRCTs051180149 | 24/01/2013 | 20/03/2019 | CBDCA plus PTX for NSCLC (squamous) with IP | Phase II study of carboplatin plus weekly paclitaxel for advanced squamous cell lung cancer with idiopathic interstitial pneumonia - IP001 | Squamous cell lung cancer Lung cancer | Carboplatin (AUC=5) given on day1 and paclitaxel (70mg/m2) given on days 1,8,15 every 4weeks until disease progression or unmanageable toxicity. | Katakami Nobuyuki | NULL | Complete | >= 20age old | Not applicable | Both | 40 | Phase 2 | Japan |
| 379 | JPRN-jRCTs061180046 | 17/01/2013 | 12/03/2019 | CBDCA, PTX and BV for NSCLC (non-sq) with IP | Phase II study of carboplatin, weekly paclitaxel and bevacizumab for advanced non-squamous cell, non-small-cell lung cancer with idiopathic interstitial pneumonia - IP002 | Non-squamous, non-small cell lung cancer Lung cancer | Carboplatin (AUC=5) given on day1, paclitaxel (70mg/m2) given on days 1,8,15 and bevacizumab (15mg/m2) on day 1 every 4weeks until disease progression or unmanageable toxicity. | Katakami Nobuyuki | NULL | Complete | >= 20age old | Not applicable | Both | 35 | Phase 2 | Japan |
| 380 | JPRN-UMIN000016706 | 2013/01/07 | 04/03/2015 | Efficacy and safety of inhaled N-acetylcysteine in idiopathic pulmonary fibrosis | Efficacy and safety of inhaled N-acetylcysteine in idiopathic pulmonary fibrosis - Efficacy of inhaled N-acetylcysteine in IPF | Idiopathic pulmonary fibrosis | N-acetylcysteine was administered by inhalation at the dose of 352.4 mg b.i.d. via an ultrasonic nebulizer. | Saitama Red Cross Hospital | NULL | Complete: follow-up complete | 40years-old | Not applicable | Male and Female | 25 | Not selected | Japan |
| 381 | JPRN-UMIN000018248 | 2012/12/01 | 09/07/2015 | Phase II study of carboplatin plus weekly paclitaxel for advanced squamous cell lung cancer with idiopathic interstitial pneumonia | Phase II study of carboplatin plus weekly paclitaxel for advanced squamous cell lung cancer with idiopathic interstitial pneumonia - Phase II study of carboplatin plus weekly paclitaxel for advanced squamous cell lung cancer with idiopathic interstitial pneumonia | advanced squamous cell lung cancer with idiopathic interstitial pneumonia | Carboplatin AUC = 5 , day1 Paclitaxel 70mg/m2, day1,8,15 4-6 cycle | IP lung cancer study group | NULL | Complete: follow-up complete | 20years-old | Not applicable | Male and Female | 40 | Phase 2 | Japan |
| 382 | NCT01524068 (ClinicalTrials.gov) | September 2012 | 27/1/2012 | A MultiCenter Study of Combined PEX, Rituximab, and Steroids in Acute Idiopathic Pulmonary Fibrosis Exacerbations | A Multicenter, Open-Label, Phase II Study of Combined Plasma Exchange (PEX), Rituximab, and Corticosteroids in Patients With Acute Idiopathic Pulmonary Fibrosis Exacerbations | Idiopathic Pulmonary Fibrosis | Drug: Standard Steroid Treatment;Drug: The Standard Steroid Treatment, Plasma Exchange and rituximab | University of Pittsburgh | NULL | Withdrawn | 18 Years | 90 Years | Both | 0 | Phase 2 | United States |
| 383 | EUCTR2011-002766-21-CZ (EUCTR) | 03/08/2012 | 19/06/2012 | Long term safety study of oral BIBF 1120 in patients with Idiopathic Pulmonary Fibrosis (IPF) | An open-label extension trial of the long term safety of oral BIBF 1120 in patients with Idiopathic Pulmonary Fibrosis (IPF) | Idiopathic Pulmonary Fibrosis MedDRA version: 20.0;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: BIBF 1120 Product Code: BIBF 1120 INN or Proposed INN: nintedanib Product Name: BIBF 1120 Product Code: BIBF 1120 INN or Proposed INN: nintedanib | Boehringer Ingelheim RCV GmbH & Co KG | NULL | Not Recruiting | Female: yes Male: yes | 750 | Phase 3 | United States;Portugal;Greece;Spain;Ireland;Russian Federation;Chile;Israel;Italy;India;France;Australia;Netherlands;China;Korea, Republic of;Finland;Turkey;United Kingdom;Czech Republic;Mexico;Canada;Argentina;Brazil;Belgium;Germany;Japan | ||
| 384 | JPRN-UMIN000008541 | 2012/07/30 | 30/07/2012 | The effect of pirfenidone on the mortality risk score in IPF | The effect of pirfenidone on the mortality risk score in IPF - The effect of pirfenidone on the mortality risk score in IPF | idiopathic pulmonary fibrosis | pirfenidone | Department of Respiratory Medicine and Allergology, Kinki University Faculty of Medicine | NULL | Complete: follow-up complete | 20years-old | Not applicable | Male and Female | 20 | Not applicable | Japan |
| 385 | EUCTR2011-002766-21-IT (EUCTR) | 25/07/2012 | 19/06/2012 | Long term safety study of oral BIBF 1120 in patients with Idiopathic Pulmonary Fibrosis (IPF) | An open-label extension trial of the long term safety of oral BIBF 1120 in patients with Idiopathic Pulmonary Fibrosis (IPF) | Idiopathic Pulmonary Fibrosis MedDRA version: 14.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: BIBF 1120 Product Code: BIBF 1120 INN or Proposed INN: nintedanib Product Name: BIBF 1120 Product Code: BIBF 1120 INN or Proposed INN: nintedanib | BOEHRINGER ING. | NULL | Not Recruiting | Female: yes Male: yes | 750 | Phase 3 | Portugal;United States;Greece;Finland;Spain;Ireland;Turkey;Russian Federation;Chile;Israel;United Kingdom;Italy;India;Czech Republic;Mexico;Canada;Argentina;Belgium;Brazil;Australia;Germany;China;Japan;Korea, Republic of | ||
| 386 | NCT01371305 (ClinicalTrials.gov) | July 16, 2012 | 3/6/2011 | STX-100 in Patients With Idiopathic Pulmonary Fibrosis (IPF) | Randomized, Double-Blind, Placebo-Controlled, Multiple Dose, Dose-Escalation Study of STX-100 in Patients With Idiopathic Pulmonary Fibrosis (IPF) | Idiopathic Pulmonary Fibrosis (IPF) | Drug: BG00011;Drug: Placebo | Biogen | NULL | Completed | 18 Years | 84 Years | All | 41 | Phase 2 | United States |
| 387 | EUCTR2011-002766-21-DE (EUCTR) | 02/07/2012 | 04/05/2012 | Long term safety study of oral BIBF 1120 in patients with Idiopathic Pulmonary Fibrosis (IPF) | An open-label extension trial of the long term safety of oral BIBF 1120 in patients with Idiopathic Pulmonary Fibrosis (IPF) | Idiopathic Pulmonary Fibrosis MedDRA version: 18.0;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: BIBF 1120 Product Code: BIBF 1120 INN or Proposed INN: nintedanib Product Name: BIBF 1120 Product Code: BIBF 1120 INN or Proposed INN: nintedanib | Boehringer Ingelheim Pharma GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 750 | Phase 3 | United States;Portugal;Greece;Spain;Ireland;Chile;Israel;Russian Federation;Italy;India;France;Australia;Netherlands;China;Korea, Republic of;Finland;Turkey;United Kingdom;Czech Republic;Mexico;Canada;Argentina;Brazil;Belgium;Germany;Japan | ||
| 388 | EUCTR2011-002766-21-BE (EUCTR) | 26/06/2012 | 26/04/2012 | Long term safety study of oral BIBF 1120 in patients with Idiopathic Pulmonary Fibrosis (IPF) | An open-label extension trial of the long term safety of oral BIBF 1120 in patients with Idiopathic Pulmonary Fibrosis (IPF) | Idiopathic Pulmonary Fibrosis MedDRA version: 17.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: BIBF 1120 Product Code: BIBF 1120 INN or Proposed INN: nintedanib Product Name: BIBF 1120 Product Code: BIBF 1120 INN or Proposed INN: nintedanib | SCS Boehringer Ingelheim Ingelheim Comm.V | NULL | Not Recruiting | Female: yes Male: yes | 750 | Phase 3 | United States;Portugal;Greece;Spain;Ireland;Chile;Israel;Russian Federation;Italy;India;France;Australia;Netherlands;China;Korea, Republic of;Finland;Turkey;United Kingdom;Czech Republic;Mexico;Canada;Argentina;Brazil;Belgium;Germany;Japan | ||
| 389 | EUCTR2011-002766-21-ES (EUCTR) | 18/06/2012 | 26/04/2012 | Long term safety study of oral BIBF 1120 in patients with Idiopathic Pulmonary Fibrosis (IPF) | An open-label extension trial of the long term safety of oral BIBF 1120 in patients with Idiopathic Pulmonary Fibrosis (IPF) | Idiopathic Pulmonary Fibrosis MedDRA version: 14.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: BIBF 1120 Product Code: BIBF 1120 INN or Proposed INN: nintedanib Product Name: BIBF 1120 Product Code: BIBF 1120 INN or Proposed INN: nintedanib | Boehringer Ingelheim España S.A | NULL | Not Recruiting | Female: yes Male: yes | 750 | Phase 3 | United States;Portugal;Greece;Spain;Ireland;Chile;Russian Federation;Israel;Italy;India;France;Australia;Netherlands;China;Korea, Republic of;Finland;Turkey;United Kingdom;Czech Republic;Mexico;Canada;Argentina;Brazil;Belgium;Germany;Japan | ||
| 390 | EUCTR2011-002766-21-GB (EUCTR) | 15/06/2012 | 21/05/2012 | Long term safety study of oral BIBF 1120 in patients with Idiopathic Pulmonary Fibrosis (IPF) | An open-label extension trial of the long term safety of oral BIBF 1120 in patients with Idiopathic Pulmonary Fibrosis (IPF) - | Idiopathic Pulmonary Fibrosis MedDRA version: 19.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: BIBF 1120 Product Code: BIBF 1120 INN or Proposed INN: nintedanib Product Name: BIBF 1120 Product Code: BIBF 1120 INN or Proposed INN: nintedanib | Boehringer Ingelheim Limited | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 750 | Phase 3 | United States;Portugal;Greece;Spain;Ireland;Russian Federation;Chile;Israel;Italy;India;France;Australia;Netherlands;China;Korea, Republic of;Finland;Turkey;United Kingdom;Czech Republic;Mexico;Canada;Argentina;Brazil;Belgium;Germany;Japan | ||
| 391 | EUCTR2011-002766-21-FI (EUCTR) | 06/06/2012 | 16/05/2012 | Long term safety study of oral BIBF 1120 in patients with Idiopathic Pulmonary Fibrosis (IPF) | An open-label extension trial of the long term safety of oral BIBF 1120 in patients with Idiopathic Pulmonary Fibrosis (IPF) | Idiopathic Pulmonary Fibrosis MedDRA version: 17.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: BIBF 1120 Product Code: BIBF 1120 INN or Proposed INN: nintedanib Product Name: BIBF 1120 Product Code: BIBF 1120 INN or Proposed INN: nintedanib | Boehringer Ingelheim | NULL | Not Recruiting | Female: yes Male: yes | 750 | Phase 3 | United States;Portugal;Greece;Spain;Ireland;Chile;Israel;Russian Federation;Italy;India;France;Australia;Netherlands;China;Korea, Republic of;Finland;Turkey;United Kingdom;Czech Republic;Mexico;Canada;Argentina;Brazil;Belgium;Germany;Japan | ||
| 392 | JPRN-UMIN000007774 | 2012/06/01 | 16/04/2012 | Phase II analysis for efficacy and safety of perioperative pirfenidone (Pirespa) therapy for patients with non-small cell lung cancer combined with idiopathic pulmonary fibrosis (IPF) | Phase II analysis for efficacy and safety of perioperative pirfenidone (Pirespa) therapy for patients with non-small cell lung cancer combined with idiopathic pulmonary fibrosis (IPF) - Perioperative pirfenidone for lung cancer with fibrosis evaluation (PEOPLE) | non-small-cell lung cancer combined with idiopathic pulmonary fibrosis | Oral administration of pirfenidone starting from 4-6 weeks before the surgery. | West Japan Oncology Group | NULL | Complete: follow-up complete | 20years-old | 75years-old | Male and Female | 42 | Phase 2 | Japan |
| 393 | EUCTR2011-002766-21-GR (EUCTR) | 02/05/2012 | 11/04/2012 | Long term safety study of oral BIBF 1120 in patients with Idiopathic Pulmonary Fibrosis (IPF) | An open-label extension trial of the long term safety of oral BIBF 1120 in patients with Idiopathic Pulmonary Fibrosis (IPF) | Idiopathic Pulmonary Fibrosis MedDRA version: 14.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: BIBF 1120 Product Code: BIBF 1120 INN or Proposed INN: nintedanib Product Name: BIBF 1120 Product Code: BIBF 1120 INN or Proposed INN: nintedanib | Boehringer Ingelheim Hellas | NULL | Not Recruiting | Female: yes Male: yes | 750 | Phase 3 | United States;Portugal;Greece;Spain;Ireland;Chile;Russian Federation;Israel;Italy;India;France;Australia;Netherlands;China;Korea, Republic of;Finland;Turkey;United Kingdom;Czech Republic;Mexico;Canada;Argentina;Brazil;Belgium;Germany;Japan | ||
| 394 | EUCTR2011-002766-21-PT (EUCTR) | 20/04/2012 | 20/04/2012 | Long term safety study of oral BIBF 1120 in patients with Idiopathic Pulmonary Fibrosis (IPF) | An open-label extension trial of the long term safety of oral BIBF 1120 in patients with Idiopathic Pulmonary Fibrosis (IPF) | Idiopathic Pulmonary Fibrosis MedDRA version: 20.0;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: BIBF 1120 Product Code: BIBF 1120 INN or Proposed INN: nintedanib Product Name: BIBF 1120 Product Code: BIBF 1120 INN or Proposed INN: nintedanib | Unilfarma - União Internacional de Lab. Farmacêuticos, Lda | NULL | Not Recruiting | Female: yes Male: yes | 750 | Phase 3 | United States;Portugal;Greece;Spain;Ireland;Russian Federation;Chile;Israel;Italy;India;France;Australia;Netherlands;China;Korea, Republic of;Finland;Turkey;United Kingdom;Czech Republic;Mexico;Canada;Argentina;Brazil;Belgium;Germany;Japan | ||
| 395 | NCT01457261 (ClinicalTrials.gov) | April 2012 | 19/10/2011 | IPF Drug Deposition Study | A Study of the Pharmacokinetics and Deposition of Inhaled Salbutamol in Patients With Idiopathic Pulmonary Fibrosis (TOPICAL-IPF) | Idiopathic Pulmonary Fibrosis | Drug: Salbutamol | Royal Brompton & Harefield NHS Foundation Trust | GlaxoSmithKline | Completed | 40 Years | N/A | Both | 10 | Phase 1 | United Kingdom |
| 396 | NCT01529853 (ClinicalTrials.gov) | April 2012 | 6/2/2012 | To Evaluate the Effect of Different Doses of SAR156597 Given to Patients With Idiopathic Pulmonary Fibrosis (IPF) | Randomized, Double-blind, Placebo-controlled Study of the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Ascending Repeated Doses of SAR156597 in Patients With Idiopathic Pulmonary Fibrosis (IPF) | Idiopathic Pulmonary Fibrosis | Drug: SAR156597;Drug: Placebo | Sanofi | NULL | Completed | 18 Years | N/A | Both | 24 | Phase 1/Phase 2 | United States;Canada;Chile;Mexico;Spain;Belgium |
| 397 | EUCTR2011-003687-78-IT (EUCTR) | 21/02/2012 | 05/03/2012 | Lanreotide Autogel for the treatment of patients with Idiopathic Pulmonary Fibrosis (IPF) | Lanreotide Autogel for the treatment of patients with Idiopathic Pulmonary Fibrosis (IPF) - IPF/LANREOTIDE/2011-01 | Idiopathic Pulmonary Fibrosis MedDRA version: 14.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | INN or Proposed INN: LANREOTIDE ACETATE Product Name: Gallium68-Dota-Noc Product Code: NA INN or Proposed INN: NA Other descriptive name: NA | AZIENDA OSPEDALIERA DI BOLOGNA POLICLINICO S. ORSOLA M. MALPIGHI | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | Italy | ||||
| 398 | NCT02699879 (ClinicalTrials.gov) | February 16, 2012 | 26/2/2016 | Evaluation of Long-Term Safety of Pirfenidone (Esbriet) in Participants With Idiopathic Pulmonary Fibrosis (IPF) | Post-Authorisation Safety Study of Esbriet® (Pirfenidone): A Prospective Observational Registry to Evaluate Long-Term Safety in a Real-World Setting | Idiopathic Pulmonary Fibrosis | Drug: Pirfenidone | Hoffmann-La Roche | NULL | Completed | N/A | N/A | All | 1009 | N/A | Austria;Denmark;Finland;France;Germany;Ireland;Italy;Norway;Sweden;United Kingdom |
| 399 | NCT01504334 (ClinicalTrials.gov) | January 2012 | 30/12/2011 | Safety and Efficacy Study of Pirfenidone to Treat Idiopathic Pulmonary Fibrosis(IPF) | A Multicenter, Randomized, Double-blind, Placebo-controlled Trial for the Safety and Efficacy of Pirfenidone in the Treatment of Idiopathic Pulmonary Fibrosis (IPF) | Idiopathic Pulmonary Fibrosis | Drug: Pirfenidone;Drug: Placebo | Beijing Kawin Technology Share-Holding Co., Ltd. | NULL | Recruiting | 18 Years | 75 Years | Both | 80 | Phase 2 | China |
| 400 | NCT02136992 (ClinicalTrials.gov) | December 2011 | 11/5/2014 | Clinical Efficacy and Safety of Pirfenidone in Patients With Idiopathic Pulmonary Fibrosis | A Multicenter, Randomized, Double-blind, Placebo-controlled Trial for Clinical Efficacy and Safety of Pirfenidone in Patients With Idiopathic Pulmonary Fibrosis | Idiopathic Pulmonary Fibrosis | Drug: Pirfenidone;Drug: placebo | Shanghai Pulmonary Hospital, Shanghai, China | Nanjing Chia-tai Tianqing Pharmaceutical | Completed | N/A | 75 Years | Both | 160 | Phase 2 | NULL |
| 401 | NCT01462006 (ClinicalTrials.gov) | October 2011 | 26/10/2011 | Double-blind Placebo-controlled Pilot Study of Sirolimus in Idiopathic Pulmonary Fibrosis (IPF) | Double-blind Placebo-controlled Pilot Study of Sirolimus in IPF | Idiopathic Pulmonary Fibrosis;Diffuse Parenchymal Lung Disease;Interstitial Lung Disease | Drug: sirolimus;Other: Placebo | University of Virginia | National Heart, Lung, and Blood Institute (NHLBI) | Completed | 21 Years | 85 Years | All | 32 | N/A | United States |
| 402 | NCT01382368 (ClinicalTrials.gov) | September 2011 | 2/5/2011 | Acute Effect of Sildenafil on Exercise Tolerance and Functional Capacity in COPD, IPF and Post Pneumonectomy Patients | Acute Effect of Sildenafil on Exercise Tolerance and Functional Capacity in COPD, IPF and Post Pneumonectomy Patients | Chronic Obstructive Pulmonary Disease;Idiopathic Pulmonary Fibrosis | Drug: Sildenafil | Rabin Medical Center | NULL | Enrolling by invitation | 30 Years | 90 Years | Both | 60 | Phase 4 | Israel |
| 403 | NCT01417156 (ClinicalTrials.gov) | September 2011 | 15/8/2011 | Safety and PK Study of BIBF 1120 in Japanese Patients With IPF: Follow up Study From 1199.31(NCT01136174) | A Phase II Open Label, Follow up Study to Investigate the Long Term Tolerability and Safety of Oral BIBF 1120 on Top of Pirfenidone in Japanese Patients With Idiopathic Pulmonary Fibrosis | Pulmonary Fibrosis | Drug: Nintedanib;Drug: Pirfenidoneone | Boehringer Ingelheim | NULL | Completed | 40 Years | N/A | All | 20 | Phase 2 | Japan |
| 404 | EUCTR2010-024211-13-DE (EUCTR) | 20/07/2011 | 12/04/2011 | Study to evaluate if macitentan is safe and tolerable enough to be used for treatment of idiopathic pulmonary fibrosis, following the MUSIC study | Long term, single-arm, open-label extension study of the MUSIC study to assess the safety and tolerability of macitentan in patients with idiopathic pulmonary fibrosis - MUSIC OL | Patients with Idiopathic Pulmonary Fibrosis MedDRA version: 13.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: Macitentan Product Code: ACT-064992 INN or Proposed INN: macitentan | ACTELION Pharmaceuticals Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 178 | Germany;Canada;Turkey;Spain;United States;Sweden;South Africa;Australia;Israel | |||
| 405 | NCT01214187 (ClinicalTrials.gov) | July 2011 | 30/9/2010 | Study of Inhaled Carbon Monoxide to Treat Idiopathic Pulmonary Fibrosis | Phase II Study of Inhaled CO for the Treatment of Idiopathic Pulmonary Fibrosis | Idiopathic Pulmonary Fibrosis | Drug: inhaled carbon monoxide;Other: Oxygen | Brigham and Women's Hospital | National Heart, Lung, and Blood Institute (NHLBI);University of California, San Francisco;University of Chicago;University of Illinois at Chicago;University of Michigan;Columbia University;Tulane University;University of Washington | Completed | 18 Years | 85 Years | All | 58 | Phase 2 | United States |
| 406 | EUCTR2010-020688-18-GB (EUCTR) | 29/06/2011 | 28/01/2011 | Safety and Efficacy of QAX576 in Patients With Progressive Idiopathic Pulmonary Fibrosis (IPF) | A randomized, double-blind, placebo-controlled, multipledose, exploratory proof of concept study to assess the safety, tolerability, efficacy, pharmacodynamics andpharmacokinetics of QAX576 in patients with rapidly progressive idiopathic pulmonary fibrosis | Patients with rapidly progressive idiopathic pulmonary fibrosis MedDRA version: 14.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders | Product Code: QAX576 | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 40 | United Kingdom | |||
| 407 | EUCTR2010-024211-13-ES (EUCTR) | 27/06/2011 | 10/11/2011 | Study to evaluate if macitentan is safe and tolerable enough to be usedfor treatment of idiopathic pulmonary fibrosis, following the MUSICstudy | Long term, single-arm, open-label extension study of the MUSIC study toassess the safety and tolerability of macitentan in patients with idiopathic pulmonary fibrosis - MUSIC OL | Patients with Idiopathic Pulmonary Fibrosis MedDRA version: 14.0;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders MedDRA version: 14.0;Level: SOC;Classification code 10038738;Term: Respiratory, thoracic and mediastinal disorders;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: Macitentan Product Code: ACT-064992 INN or Proposed INN: macitentan | ACTELION Pharmaceuticals Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 178 | Phase 2 | United States;Slovenia;Canada;Spain;Turkey;Australia;South Africa;Israel;Germany;Sweden | ||
| 408 | EUCTR2010-024252-29-NL (EUCTR) | 16/06/2011 | 11/05/2011 | A 52 weeks, double blind, randomized, placebo-controlled trial evaluating the effect of oral BIBF 1120, 150 mg twice daily, on Forced Vital Capacity decline , in patients with Idiopathic Pulmonary Fibrosis (IPF) | A 52 weeks, double blind, randomized, placebo-controlled trial evaluating the effect of oral BIBF 1120, 150 mg twice daily, on Forced Vital Capacity decline , in patients with Idiopathic Pulmonary Fibrosis (IPF) | Idiopathic Pulmonary Fibrosis MedDRA version: 12.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis | Product Name: BIBF 1120 Product Code: BIBF 1120 Product Name: BIBF 1120 Product Code: BIBF 1120 | Boehringer Ingelheim | NULL | Not Recruiting | Female: yes Male: yes | 485 | Portugal;Greece;Finland;Spain;Germany;Netherlands | |||
| 409 | EUCTR2010-024211-13-SI (EUCTR) | 13/06/2011 | 11/07/2011 | Study to evaluate if macitentan is safe and tolerable enough to be used for treatment of idiopathic pulmonary fibrosis, following the MUSIC study | Long term, single-arm, open-label extension study of the MUSIC study to assess the safety and tolerability of macitentan in patients with idiopathic pulmonary fibrosis - MUSIC OL | Patients with Idiopathic Pulmonary Fibrosis MedDRA version: 14.0;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: Macitentan Product Code: ACT-064992 INN or Proposed INN: macitentan | ACTELION Pharmaceuticals Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 178 | Phase 2 | United States;Slovenia;Canada;Spain;Turkey;Australia;South Africa;Israel;Germany;Sweden | ||
| 410 | EUCTR2010-023828-24-GB (EUCTR) | 09/06/2011 | 27/04/2011 | The effect of Thalidomide on sputum biomarkers in IPF cough. - The effect of Thalidomide on sputum biomarkers in IPF cough | The effect of Thalidomide on sputum biomarkers in IPF cough. - The effect of Thalidomide on sputum biomarkers in IPF cough | Cough in Idiopathic Pulmonary fibrosis. | Trade Name: Thalidomide Pharmion Product Name: Thalidomide Pharmion Trade Name: PREDNISOLONE Product Name: prednisolone | University of Nottingham | NULL | Not Recruiting | Female: yes Male: yes | United Kingdom | ||||
| 411 | NCT01366209 (ClinicalTrials.gov) | June 2011 | 2/6/2011 | Efficacy and Safety of Pirfenidone in Patients With Idiopathic Pulmonary Fibrosis (IPF) | A Randomized, Double-Blind, Placebo Controlled, Phase 3 Study of the Efficacy and Safety of Pirfenidone in Patients With Idiopathic Pulmonary Fibrosis (ASCEND Trial) | Idiopathic Pulmonary Fibrosis | Drug: Pirfenidone;Drug: Placebo | Genentech, Inc. | NULL | Completed | 40 Years | 80 Years | All | 555 | Phase 3 | United States |
| 412 | EUCTR2010-024211-13-SE (EUCTR) | 26/05/2011 | 05/04/2011 | Study to evaluate if macitentan is safe and tolerable enough to be used for treatment of idiopathic pulmonary fibrosis, following the MUSIC study | Long term, single-arm, open-label extension study of the MUSIC study to assess the safety and tolerability of macitentan in patients with idiopathic pulmonary fibrosis - MUSIC OL | Patients with Idiopathic Pulmonary Fibrosis MedDRA version: 13.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: Macitentan Product Code: ACT-064992 INN or Proposed INN: macitentan | ACTELION Pharmaceuticals Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 178 | Phase 2 | United States;Slovenia;Canada;Spain;Turkey;Australia;South Africa;Israel;Germany;Sweden | ||
| 413 | EUCTR2010-024252-29-ES (EUCTR) | 25/05/2011 | 03/11/2011 | - | A 52 weeks, double blind, randomized, placebo-controlled trial evaluating the effect of oral BIBF 1120, 150 mg twice daily, on annual Forced Vital Capacity decline , in patients with Idiopathic Pulmonary Fibrosis (IPF) | Idiopathic Pulmonary Fibrosis MedDRA version: 14.0;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: BIBF 1120 Product Code: BIBF 1120 INN or Proposed INN: BIBF1120 Product Name: BIBF 1120 Product Code: BIBF 1120 INN or Proposed INN: BIBF1120 | Boehringer Ingelheim España, S.A. | NULL | Not Recruiting | Female: yes Male: yes | 485 | Phase 3 | United States;Portugal;Greece;Finland;Spain;Turkey;Russian Federation;Chile;India;France;Mexico;Canada;Germany;Netherlands;China;Japan;Korea, Republic of | ||
| 414 | EUCTR2010-024251-87-BE (EUCTR) | 18/05/2011 | 17/03/2011 | A 52 weeks, double blind, randomized, placebo-controlled trial evaluating the effect of oral BIBF 1120, 150 mg twice daily, on annual Forced Vital Capacity decline , in patients with Idiopathic Pulmonary Fibrosis (IPF) | A 52 weeks, double blind, randomized, placebo-controlled trial evaluating the effect of oral BIBF 1120, 150 mg twice daily, on annual Forced Vital Capacity decline , in patients with Idiopathic Pulmonary Fibrosis (IPF) | Idiopathic Pulmonary Fibrosis MedDRA version: 14.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders | Product Name: BIBF 1120 Product Code: BIBF 1120 Product Name: BIBF 1120 Product Code: BIBF 1120 | SCS Boehringer Ingelheim Comm.V | NULL | Not Recruiting | Female: yes Male: yes | 485 | Phase 3 | United States;Ireland;Israel;Italy;United Kingdom;India;France;Czech Republic;Argentina;Belgium;Brazil;Australia;Germany;Japan;China | ||
| 415 | EUCTR2010-024252-29-PT (EUCTR) | 13/05/2011 | 16/02/2011 | A 52 weeks, double blind, randomized, placebo-controlled trial evaluating the effect of oral BIBF 1120, 150 mg twice daily, on Forced Vital Capacity decline , in patients with Idiopathic Pulmonary Fibrosis (IPF) | A 52 weeks, double blind, randomized, placebo-controlled trial evaluating the effect of oral BIBF 1120, 150 mg twice daily, on Forced Vital Capacity decline , in patients with Idiopathic Pulmonary Fibrosis (IPF) | Idiopathic Pulmonary Fibrosis MedDRA version: 14.0;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: BIBF 1120 Product Code: BIBF 1120 Product Name: BIBF 1120 Product Code: BIBF 1120 | Boehringer Ingelheim France | NULL | Not Recruiting | Female: yes Male: yes | 485 | China;Japan;Korea, Republic of;United States;Portugal;Greece;Finland;Spain;Russian Federation;India;France;Mexico;Canada;Germany;Netherlands | |||
| 416 | EUCTR2010-024251-87-IE (EUCTR) | 11/05/2011 | 23/03/2011 | A 52 weeks, double blind, randomized, placebo-controlled trial evaluating the effect of oral BIBF 1120, 150 mg twice daily, on annual Forced Vital Capacity decline , in patients with Idiopathic Pulmonary Fibrosis (IPF) | A 52 weeks, double blind, randomized, placebo-controlled trial evaluating the effect of oral BIBF 1120, 150 mg twice daily, on annual Forced Vital Capacity decline , in patients with Idiopathic Pulmonary Fibrosis (IPF) | Idiopathic Pulmonary Fibrosis MedDRA version: 14.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders | Product Name: BIBF 1120 Product Code: BIBF 1120 Product Name: BIBF 1120 Product Code: BIBF 1120 | Boehringer Ingelheim Limited | NULL | Not Recruiting | Female: yes Male: yes | 485 | Czech Republic;Belgium;Ireland;Germany;Italy;United Kingdom | |||
| 417 | EUCTR2010-024251-87-IT (EUCTR) | 10/05/2011 | 19/09/2011 | A 52 weeks, double blind, randomized, placebo-controlled trial evaluating the effect of oral BIBF 1120, 150 mg twice daily, on annual Forced Vital Capacity decline , in patients with Idiopathic Pulmonary Fibrosis (IPF) | A 52 weeks, double blind, randomized, placebo-controlled trial evaluating the effect of oral BIBF 1120, 150 mg twice daily, on annual Forced Vital Capacity decline , in patients with Idiopathic Pulmonary Fibrosis (IPF) | Idiopathic Pulmonary Fibrosis MedDRA version: 14.0;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Code: BIBF 1120 Product Code: BIBF 1120 | BOEHRINGER ING. | NULL | Not Recruiting | Female: yes Male: yes | 646 | Czech Republic;Belgium;Ireland;Germany;United Kingdom;Italy | |||
| 418 | EUCTR2010-024252-29-GR (EUCTR) | 02/05/2011 | 04/04/2011 | A 52 weeks, double blind, randomized, placebo-controlled trial evaluating the effect of oral BIBF 1120, 150 mg twice daily, on Forced Vital Capacity decline , in patients with Idiopathic Pulmonary Fibrosis (IPF) | A 52 weeks, double blind, randomized, placebo-controlled trial evaluating the effect of oral BIBF 1120, 150 mg twice daily, on Forced Vital Capacity decline , in patients with Idiopathic Pulmonary Fibrosis (IPF) | Idiopathic Pulmonary Fibrosis MedDRA version: 13.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders | Product Name: BIBF 1120 Product Code: BIBF 1120 Product Name: BIBF 1120 Product Code: BIBF 1120 | Boehringer Ingelheim | NULL | Not Recruiting | Female: yes Male: yes | 485 | Portugal;Greece;Finland;Spain;Netherlands;Germany | |||
| 419 | NCT01335477 (ClinicalTrials.gov) | May 2011 | 13/4/2011 | Safety and Efficacy of BIBF 1120 at High Dose in Idiopathic Pulmonary Fibrosis Patients II | A 52 Weeks, Double Blind, Randomized, Placebo-controlled Trial Evaluating the Effect of Oral BIBF 1120, 150 mg Twice Daily, on Annual Forced Vital Capacity Decline, in Patients With Idiopathic Pulmonary Fibrosis (IPF) | Pulmonary Fibrosis | Drug: placebo;Drug: BIBF 1120 | Boehringer Ingelheim | NULL | Completed | 40 Years | N/A | All | 551 | Phase 3 | United States;Canada;Chile;China;Finland;France;Germany;Greece;India;Japan;Korea, Republic of;Mexico;Netherlands;Portugal;Russian Federation;Spain;Turkey |
| 420 | EUCTR2010-024251-87-GB (EUCTR) | 28/04/2011 | 24/02/2011 | Safety and efficacy of BIBF 1120 at high dose in Idiopathic Pulmonary Fibrosis patients | A 52 weeks, double blind, randomized, placebo-controlled trial evaluating the effect of oral BIBF 1120, 150 mg twice daily, on annual Forced Vital Capacity decline , in patients with Idiopathic Pulmonary Fibrosis (IPF) | Idiopathic Pulmonary Fibrosis MedDRA version: 14.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders | Product Name: BIBF 1120 Product Code: BIBF 1120 Product Name: BIBF 1120 Product Code: BIBF 1120 | Boehringer Ingelheim Limited | NULL | Not Recruiting | Female: yes Male: yes | 485 | Phase 3 | Czech Republic;Belgium;Ireland;Germany;Italy;United Kingdom | ||
| 421 | EUCTR2010-024251-87-CZ (EUCTR) | 26/04/2011 | 08/04/2011 | Safety and Efficacy of BIBF 1120 at high dose in Idiopathic Pulmonary Fibrosis patients | A 52 weeks, double blind, randomized, placebo-controlled trial evaluating the effect of oral BIBF 1120, 150 mg twice daily, on annual Forced Vital Capacity decline , in patients with Idiopathic Pulmonary Fibrosis (IPF) | Idiopathic Pulmonary Fibrosis MedDRA version: 14.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: BIBF 1120 Product Code: BIBF 1120 Product Name: BIBF 1120 Product Code: BIBF 1120 | Boehringer Ingelheim RCV GmBH & Co KG | NULL | Not Recruiting | Female: yes Male: yes | 485 | India;Czech Republic;Argentina;Brazil;Belgium;Australia;Germany;China;Japan;United States;Ireland;Israel;Italy;United Kingdom | |||
| 422 | EUCTR2010-024251-87-DE (EUCTR) | 12/04/2011 | 09/02/2011 | Safety and Efficacy of BIBF 1120 at high dose in Idiopathic Pulmonary Fibrosis patients | A 52 weeks, double blind, randomized, placebo-controlled trial evaluating the effect of oral BIBF 1120, 150 mg twice daily, on annual Forced Vital Capacity decline , in patients with Idiopathic Pulmonary Fibrosis (IPF) | Idiopathic Pulmonary Fibrosis MedDRA version: 14.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: BIBF 1120 Product Code: BIBF 1120 Product Name: BIBF 1120 Product Code: BIBF 1120 | Boehringer Ingelheim Pharma GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 485 | United States;Ireland;Israel;Italy;United Kingdom;India;France;Czech Republic;Argentina;Belgium;Brazil;Australia;Germany;Japan;China | |||
| 423 | EUCTR2010-024252-29-DE (EUCTR) | 07/04/2011 | 09/02/2011 | Safety and Efficacy of BIBF 1120 at high dose in Idiopathic Pulmonary Fibrosis patients | A 52 weeks, double blind, randomized, placebo-controlled trial evaluating the effect of oral BIBF 1120, 150 mg twice daily, on Forced Vital Capacity decline , in patients with Idiopathic Pulmonary Fibrosis (IPF) | Idiopathic Pulmonary Fibrosis MedDRA version: 14.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders MedDRA version: 14.1;Classification code 10037383;Term: Pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: BIBF 1120 Product Code: BIBF 1120 Product Name: BIBF 1120 Product Code: BIBF 1120 | Boehringer Ingelheim Pharma GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 485 | Portugal;United States;Greece;Finland;Spain;Turkey;Russian Federation;Chile;India;France;Mexico;Canada;Netherlands;Germany;Japan;China;Korea, Republic of | |||
| 424 | EUCTR2010-024252-29-FI (EUCTR) | 01/04/2011 | 04/02/2011 | A 52 weeks, double blind, randomized, placebo-controlled trial evaluating the effect of oral BIBF 1120, 150 mg twice daily, on Forced Vital Capacity decline , in patients with Idiopathic Pulmonary Fibrosis (IPF) | A 52 weeks, double blind, randomized, placebo-controlled trial evaluating the effect of oral BIBF 1120, 150 mg twice daily, on Forced Vital Capacity decline , in patients with Idiopathic Pulmonary Fibrosis (IPF) | Idiopathic Pulmonary Fibrosis MedDRA version: 12.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis | Product Name: BIBF 1120 Product Code: BIBF 1120 Product Name: BIBF 1120 Product Code: BIBF 1120 | Boehringer Ingelheim | NULL | Not Recruiting | Female: yes Male: yes | 485 | Portugal;Greece;Finland;Spain;Netherlands;Germany | |||
| 425 | NCT01335464 (ClinicalTrials.gov) | April 2011 | 13/4/2011 | Safety and Efficacy of BIBF 1120 at High Dose in Idiopathic Pulmonary Fibrosis Patients | A 52 Weeks, Double Blind, Randomized, Placebo-controlled Trial Evaluating the Effect of Oral BIBF 1120, 150 mg Twice Daily, on Annual Forced Vital Capacity Decline, in Patients With Idiopathic Pulmonary Fibrosis (IPF) | Pulmonary Fibrosis | Drug: placebo;Drug: BIBF 1120 | Boehringer Ingelheim | NULL | Completed | 40 Years | N/A | All | 515 | Phase 3 | United States;Australia;Belgium;China;Czech Republic;France;Germany;India;Ireland;Israel;Italy;Japan;United Kingdom;Argentina;Brazil |
| 426 | NCT01266317 (ClinicalTrials.gov) | March 2011 | 22/12/2010 | Combined PEX, Rituximab and Steroids in Acute Idiopathic Pulmonary Fibrosis Exacerbations | Open-Label, Feasibility Study of Combined Plasma Exchange (PEX), Rituximab, and Corticosteroids in Patients With Acute Idiopathic Pulmonary Fibrosis Exacerbations | IPF | Drug: Combined Plasma Exchange (PEX), Rituximab, and Corticosteroids | Michael Donahoe | NULL | Completed | 18 Years | 80 Years | All | 9 | Phase 1/Phase 2 | United States |
| 427 | NCT01265888 (ClinicalTrials.gov) | March 2011 | 20/12/2010 | Study in Subjects With PAH and PH Secondary to IPF Using Inhaled GeNOsyl. | A Phase 2, Open-Label, Dose-Escalation Study in Subjects With Pulmonary Arterial Hypertension, (PAH, WHO Group 1) and Pulmonary Hypertension Secondary to Idiopathic Pulmonary Fibrosis, (PH-IPF WHO Group 3) Using Inhaled GeNOsyl. | Pulmonary Arterial Hypertension;Idiopathic Pulmonary Fibrosis | Drug: Inhaled Nitric Oxide | Geno LLC | NULL | Completed | 18 Years | 80 Years | Both | 31 | Phase 2 | United States |
| 428 | NCT01262001 (ClinicalTrials.gov) | March 2011 | 15/12/2010 | Safety, Tolerability, and Efficacy Study of Idiopathic Pulmonary Fibrosis | A Phase 2, Open-Label, Dose-Escalation Study to Evaluate the Safety, Tolerability, and Efficacy of FG-3019 in Subjects With Idiopathic Pulmonary Fibrosis | Idiopathic Pulmonary Fibrosis | Drug: FG-3019 | FibroGen | NULL | Completed | 35 Years | 80 Years | All | 90 | Phase 2 | United States |
| 429 | ChiCTR-TRC-12002372 | 2011-02-23 | 2012-07-15 | Levofloxacin (Cravit) versus Moxifloxacin-concentration of epithelial lining fluid in patients with idiopathic pulmonary fibrosis (IPF) | Levofloxacin (Cravit) versus Moxifloxacin-concentration of epithelial lining fluid in patients with idiopathic pulmonary fibrosis | idiopathic pulmonary fibrosis | Cravit IPF Group:Cravit 500 mg per time;Cravit Normal Pulmonary Function Group:Cravit 500 mg per time;Moxifloxacin IPF Group:Moxifloxacin 400mg per time;Moxifloxacin Normal PulmonaryFunction Group:Moxifloxacin 400mg per time; | Respiratory Department, Peking Union Medical College Hospital | NULL | Completed | 18 | 70 | Both | Cravit IPF Group:12;Cravit Normal Pulmonary Function Group:12;Moxifloxacin IPF Group:12;Moxifloxacin Normal PulmonaryFunction Group:12; | China | |
| 430 | JPRN-UMIN000005098 | 2011/02/01 | 18/02/2011 | A randomized trial of ambulatory oxygen in patients with idiopathic pulmonary fibrosis and desaturation but without resting hypoxemia | A randomized trial of ambulatory oxygen in patients with idiopathic pulmonary fibrosis and desaturation but without resting hypoxemia - ambulatory oxygen in patients with IPF and desaturation but without resting hypoxemia | idiopathic pulmonary fibrosis | ambulatory oxygen ambulatory air | Department of Respiratory Medicine and Allergology, Kinki University School of Medicine | NULL | Complete: follow-up complete | 20years-old | Not applicable | Male and Female | 20 | Not selected | Japan |
| 431 | EUCTR2009-011169-98-CZ (EUCTR) | 10/01/2011 | 29/11/2010 | ARTEMIS-PH: A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multi-Center, Parallel-Group Study to Evaluate the Efficacy and Safety of Ambrisentan in Subjects with Idiopathic Pulmonary Fibrosis and Pulmonary Hypertension - ARTEMIS-PH | ARTEMIS-PH: A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multi-Center, Parallel-Group Study to Evaluate the Efficacy and Safety of Ambrisentan in Subjects with Idiopathic Pulmonary Fibrosis and Pulmonary Hypertension - ARTEMIS-PH | Pulmonary Hypertension associated with Idiopathic Pulmonary Fibrosis MedDRA version: 12.1;Level: LLT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis MedDRA version: 12.1;Classification code 10037400;Term: Pulmonary hypertension | Trade Name: Letairis INN or Proposed INN: Ambrisentan Trade Name: Letairis INN or Proposed INN: Ambrisentan | Gilead Sciences, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 225 | Phase 3 | United Kingdom;Germany;Czech Republic;Italy;Austria | ||
| 432 | JPRN-UMIN000004749 | 2011/01/01 | 18/12/2010 | A study to evaluate the long-term effect of pulmonary hypertension on prognosis, activities of daily living (ADL), cardiac function and pulmonary function in patients with COPD and idiopathic pulmonary fibrosis (IPF), respectively, according to baseline severity of pulmonary hypertension and the efficacy and safety of the Tracleer (bosentan hydrate) tablet for prognosis, activities of daily living, cardiac function and pulmonary function in patients with COPD and IPF, respectively, according to baseline severity of pulmonary hypertension. | A study to evaluate the long-term effect of pulmonary hypertension on prognosis, activities of daily living (ADL), cardiac function and pulmonary function in patients with COPD and idiopathic pulmonary fibrosis (IPF), respectively, according to baseline severity of pulmonary hypertension and the efficacy and safety of the Tracleer (bosentan hydrate) tablet for prognosis, activities of daily living, cardiac function and pulmonary function in patients with COPD and IPF, respectively, according to baseline severity of pulmonary hypertension. - A study to evaluate the long-term effect of pulmonary hypertension on prognosis, activities of daily living (ADL), cardiac function and pulmonary function in patients with COPD and idiopathic pulmonary fibrosis (IPF), respectively, according to baseline severity of pulmonary hypertension and the efficacy and safety of the Tracleer (bosentan hydrate) tablet for prognosis, activities of daily living, cardiac function and pulmonary function in patients with COPD and IPF, respectively, according to baseline severity of pulmonary hypertension. | Patients with COPD or IPF (WHO functional class II, III or IV), without hypoxia (PaO2 at rest<90mmHg or after 6minutes walk), who provide their informed consent to participate in this study. | Treated subgroup In patients with COPD without hypoxia (PaO2<60mmHg at rest or after 6 minutes walk) (WHO functional class II, III or IV), patients with Pulmonary hypertension with evidense of mPAP at rest=/>35mmHg : 20subjects Bosentan will be administered basically according to the approved dosage and administration, as specified below. However, in this study conducted in accordance with routine clinical practice, the initial dosage may be used continuously if considered appropriate based on the patient's condition. Treatment with bosentan in adults is usually initiated at a dose of 62.5 mg twice daily to be taken orally after breakfast and the evening meal for 4 weeks. From Week 5 of treatment, bosentan is administered at a dose of 125 mg twice daily to be taken orally after breakfast and evening meal. The dosage should be adjusted according to the patient's symptoms and tolerability, but should not exceed 250 mg per day. Duration of study drug administration: 24 months In addition, Interventions/Control 11 and 12 is described in Interventions/control 10. Treated subgroup In patients with COPD without hypoxia (PaO2<60mmHg at rest or after 6 minutes walk) (WHO functional class II, III or IV), patients with boarderline pulmonary hypertension or pulmonary hypertension (mPAP at rest=/>25mmHg and/or mPAP on effort=/>30mmHg) with mPAP at rest<35mmHg: 20subjects Tracleer Tablets will be administered basically according to the approved dosage and administration, as specified below. However, in this study conducted in accordance with routine clinical practice, the initial dosage may be used continuously if considered appropriate based on the patient's condition. Treatment with bosentan in adults is usually initiated at a dose of 62.5 mg twice d | Department of Respiratory Medicine, Chiba-Hokusoh Hospital, Nippon Medical School | NULL | Recruiting | 40years-old | Not applicable | Male and Female | 160 | Not applicable | Japan |
| 433 | NCT01254409 (ClinicalTrials.gov) | January 2011 | 3/12/2010 | A Phase 1b Study of IV PRM151 in Patients With Idiopathic Pulmonary Fibrosis (IPF) | A Randomized, Double-Masked, Sponsor-Unmasked, Ascending Multiple Dose Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of PRM-151 Administered Intravenously to Patients With Idiopathic Pulmonary Fibrosis | Idiopathic Pulmonary Fibrosis | Biological: PRM-151;Other: Placebo | Hoffmann-La Roche | NULL | Completed | 40 Years | 80 Years | All | 21 | Phase 1 | United States;Netherlands |
| 434 | NCT01362231 (ClinicalTrials.gov) | December 2010 | 12/4/2011 | A Study to Evaluate the Safety and Efficacy of GS-6624 (Formerly AB0024) in Patients With Idiopathic Pulmonary Fibrosis | A Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of GS-6624 in Adult Subjects With Idiopathic Pulmonary Fibrosis | Idiopathic Pulmonary Fibrosis | Drug: GS-6624 | Gilead Sciences | NULL | Completed | 40 Years | 85 Years | Both | 48 | Phase 1 | United States |
| 435 | NCT01266135 (ClinicalTrials.gov) | December 2010 | 17/12/2010 | Safety and Efficacy of QAX576 in Patients With Idiopathic Pulmonary Fibrosis (IPF) | Randomized, Double-blind, Placebo-controlled, Multiple-dose, Exploratory Proof of Concept Study to Assess the Safety, Tolerability, Efficacy, Pharmacodynamic (PD) and Pharmacokinetics of QAX576 in Patients With Rapidly Progressive IPF | Idiopathic Pulmonary Fibrosis | Drug: QAX576;Drug: Placebo | Novartis Pharmaceuticals | NULL | Terminated | 18 Years | 80 Years | All | 40 | Phase 2 | United States;United Kingdom |
| 436 | EUCTR2009-013788-21-BG (EUCTR) | 05/10/2010 | 18/08/2010 | A phase II open label, roll over study of the long term tolerability,safety and efficacy of oral BIBF 1120 in patients with IdiopathicPulmonary Fibrosis | A phase II open label, roll over study of the long term tolerability,safety and efficacy of oral BIBF 1120 in patients with IdiopathicPulmonary Fibrosis | Idiopathic Pulmonary Fibrosis MedDRA version: 16.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders | Product Name: BIBF 1120 Product Code: BIBF 1120 Product Name: BIBF 1120 Product Code: BIBF 1120 Product Name: BIBF 1120 Product Code: BIBF 1120 | Boehringer Ingelheim RCV GmBH & Co KG | NULL | Not Recruiting | Female: yes Male: yes | 300 | Phase 2 | Portugal;France;Czech Republic;Hungary;Greece;Belgium;Spain;Ireland;Bulgaria;Germany;United Kingdom;Italy | ||
| 437 | EUCTR2008-004405-34-CZ (EUCTR) | 13/09/2010 | 07/01/2009 | A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multi-Center, Parallel-Group, Event-Driven Study to Evaluate the Efficacy and Safety of Ambrisentan in Subjects with Early Idiopathic Pulmonary Fibrosis (IPF) - ARTEMIS-IPF | A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multi-Center, Parallel-Group, Event-Driven Study to Evaluate the Efficacy and Safety of Ambrisentan in Subjects with Early Idiopathic Pulmonary Fibrosis (IPF) - ARTEMIS-IPF | Idiopathic pulmonary fibrosis (IPF) MedDRA version: 9.1;Level: LLT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis | Trade Name: Letairis 5 mg INN or Proposed INN: Ambrisentan Trade Name: Letairis 10 mg INN or Proposed INN: Ambrisentan | Gilead Sciences Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 660 | Phase 3 | United Kingdom;Germany;Czech Republic;Netherlands;Belgium;France;Spain;Ireland;Italy;Austria | ||
| 438 | NCT01199887 (ClinicalTrials.gov) | September 2010 | 9/9/2010 | Trial Of IW001 in Patients With Idiopathic Pulmonary Fibrosis | A Phase One, Open Label, Multi-Dose Study to Evaluate the Safety, Tolerability, and Biologic Effects of Three Doses of IW001 in Patients With Idiopathic Pulmonary Fibrosis (IPF) | Idiopathic Pulmonary Fibrosis | Drug: IW001 | ImmuneWorks | NULL | Completed | 35 Years | 75 Years | Both | 30 | Phase 1 | United States |
| 439 | EUCTR2009-013788-21-IE (EUCTR) | 05/08/2010 | 20/05/2010 | A phase II open label, roll over study of the long term tolerability,safety and efficacy of oral BIBF 1120 in patients with IdiopathicPulmonary Fibrosis | A phase II open label, roll over study of the long term tolerability,safety and efficacy of oral BIBF 1120 in patients with IdiopathicPulmonary Fibrosis | Idiopathic Pulmonary Fibrosis MedDRA version: 12.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis | Product Name: BIBF 1120 Product Code: BIBF 1120 Product Name: BIBF 1120 Product Code: BIBF 1120 Product Name: BIBF 1120 Product Code: BIBF 1120 | Boehringer Ingelheim Ltd | NULL | Not Recruiting | Female: yes Male: yes | 300 | Phase 2 | Portugal;France;Czech Republic;Hungary;Greece;Belgium;Spain;Ireland;Bulgaria;Germany;United Kingdom;Italy | ||
| 440 | EUCTR2010-020223-44-AT (EUCTR) | 03/08/2010 | 29/06/2010 | (18)F-FDG PET/CT in patients with idiopathic interstitial pneumonias: correlation of tracer uptake and histological findings, and texture-based recognition of usual interstitial pneumonia | (18)F-FDG PET/CT in patients with idiopathic interstitial pneumonias: correlation of tracer uptake and histological findings, and texture-based recognition of usual interstitial pneumonia | Interstitial lung disease of unknown etiology | Trade Name: (18)F-FDG Product Name: (18)F-FDG INN or Proposed INN: FLUORINE (18F) FLUDEOXYGLUCOSE | Medizinische Universität Wien, Univ.Klinik f.Radiodiagnostik | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | Austria | ||||
| 441 | EUCTR2008-001281-86-DE (EUCTR) | 02/08/2010 | 16/03/2010 | A Phase 2, Multicenter, Multinational, Randomized, Double-blind, Placebo-controlled, Parallel-group, Dose-ranging Study Evaluating the Efficacy and Safety of CNTO 888 Administered Intravenously in Subjects with Idiopathic Pulmonary Fibrosis | A Phase 2, Multicenter, Multinational, Randomized, Double-blind, Placebo-controlled, Parallel-group, Dose-ranging Study Evaluating the Efficacy and Safety of CNTO 888 Administered Intravenously in Subjects with Idiopathic Pulmonary Fibrosis | Idiopathic pulmonary fibrosis (IPF) MedDRA version: 9.1;Level: LLT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis | Product Name: CNTO888 Product Code: CNTO888 | Janssen Biologics B.V. | NULL | Not Recruiting | Female: yes Male: yes | 120 | Phase 2 | Germany;Netherlands;Belgium | ||
| 442 | EUCTR2009-013788-21-CZ (EUCTR) | 02/08/2010 | 28/07/2010 | study of the long term tolerability, safety and efficacy of oral BIBF 1120 in patients with Idiopathic Pulmonary Fibrosis | A phase II open label, roll over study of the long term tolerability, safety and efficacy of oral BIBF 1120 in patients with Idiopathic Pulmonary Fibrosis | Idiopathic Pulmonary Fibrosis MedDRA version: 19.0;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: BIBF 1120 Product Code: BIBF 1120 INN or Proposed INN: nintedanib Product Name: BIBF 1120 Product Code: BIBF 1120 INN or Proposed INN: nintedanib Product Name: BIBF 1120 Product Code: BIBF 1120 INN or Proposed INN: nintedanib | Boehringer Ingelheim RCV GmbH & Co KG | NULL | Not Recruiting | Female: yes Male: yes | 300 | Phase 2 | Portugal;Greece;Spain;Ireland;Russian Federation;Italy;United Kingdom;France;Czech Republic;Hungary;Belgium;Bulgaria;Germany | ||
| 443 | EUCTR2009-013788-21-GR (EUCTR) | 14/07/2010 | 15/11/2010 | A phase II open label, roll over study of the long term tolerability,safety and efficacy of oral BIBF 1120 in patients with IdiopathicPulmonary Fibrosis | A phase II open label, roll over study of the long term tolerability,safety and efficacy of oral BIBF 1120 in patients with IdiopathicPulmonary Fibrosis | Idiopathic Pulmonary Fibrosis MedDRA version: 12.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis | Product Name: BIBF 1120 Product Code: BIBF 1120 Product Name: BIBF 1120 Product Code: BIBF 1120 Product Name: BIBF 1120 Product Code: BIBF 1120 | Boehringer Ingelheim Ellas AE | NULL | Not Recruiting | Female: yes Male: yes | 300 | Phase 2 | Portugal;France;Czech Republic;Hungary;Greece;Belgium;Spain;Ireland;Bulgaria;Germany;United Kingdom;Italy | ||
| 444 | NCT01170065 (ClinicalTrials.gov) | June 25, 2010 | 6/7/2010 | Roll Over Study From 1199.30 BIBF 1120 in Idiopathic Pulmonary Fibrosis (IPF) | A Phase II Open Label, Roll Over Study of the Long Term Tolerability, Safety and Efficacy of Oral BIBF 1120 in Patients With Idiopathic Pulmonary Fibrosis | Pulmonary Fibrosis | Drug: BIBF 1120 | Boehringer Ingelheim | NULL | Completed | 40 Years | N/A | All | 198 | Phase 2 | Argentina;Australia;Belgium;Brazil;Bulgaria;Canada;Chile;China;Czechia;France;Germany;Greece;Hungary;Ireland;Italy;Mexico;Netherlands;Portugal;Russian Federation;Spain;United Kingdom;Czech Republic;El Salvador |
| 445 | EUCTR2009-013788-21-HU (EUCTR) | 16/06/2010 | 05/07/2010 | A phase II open label, roll over study of the long term tolerability, safety and efficacy of oral BIBF 1120 in patients with Idiopathic Pulmonary Fibrosis | A phase II open label, roll over study of the long term tolerability, safety and efficacy of oral BIBF 1120 in patients with Idiopathic Pulmonary Fibrosis | Idiopathic Pulmonary Fibrosis MedDRA version: 17.0;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: BIBF 1120 Product Code: BIBF 1120 INN or Proposed INN: Nintedanib Other descriptive name: Not applicable Product Name: BIBF 1120 Product Code: BIBF 1120 INN or Proposed INN: Nintedanib Other descriptive name: Not applicable Product Name: BIBF 1120 Product Code: BIBF 1120 INN or Proposed INN: Nintedanib Other descriptive name: Not applicable | Boehringer Ingelheim RCV GmBH & Co KG | NULL | Not Recruiting | Female: yes Male: yes | 300 | Phase 2 | Portugal;France;Czech Republic;Hungary;Greece;Belgium;Spain;Ireland;Bulgaria;Germany;United Kingdom;Italy | ||
| 446 | EUCTR2009-013788-21-GB (EUCTR) | 04/06/2010 | 11/10/2010 | A phase II open label, roll over study of the long term tolerability,safety and efficacy of oral BIBF 1120 in patients with IdiopathicPulmonary Fibrosis | A phase II open label, roll over study of the long term tolerability,safety and efficacy of oral BIBF 1120 in patients with IdiopathicPulmonary Fibrosis | Idiopathic Pulmonary Fibrosis MedDRA version: 18.0;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders | Product Name: BIBF 1120 Product Code: BIBF 1120 Product Name: BIBF 1120 Product Code: BIBF 1120 Product Name: BIBF 1120 Product Code: BIBF 1120 | Boehringer Ingelheim Limited | NULL | Not Recruiting | Female: yes Male: yes | 300 | Phase 2 | Portugal;France;Czech Republic;Hungary;Greece;Belgium;Spain;Ireland;Bulgaria;Germany;Italy;United Kingdom | ||
| 447 | NCT01135199 (ClinicalTrials.gov) | June 2010 | 28/5/2010 | Pomalidomide for Cough in Patients With Idiopathic Pulmonary Fibrosis | Safety and Efficacy of Pomalidomide in the Treatment of Refractory Cough in Patients With Idiopathic Pulmonary Fibrosis (IPF): A Pilot Study | Pulmonary Fibrosis | Drug: pomalidomide (CC-4047 | Stanford University | Celgene Corporation | Withdrawn | 18 Years | N/A | Both | 0 | Phase 2 | United States |
| 448 | EUCTR2009-013788-21-DE (EUCTR) | 27/05/2010 | 22/04/2010 | Roll over study from 1199.30 BIBF 1120 in Idiopathic Pulmonary Fibrosis (IPF) | A phase II open label, roll over study of the long term tolerability,safety and efficacy of oral BIBF 1120 in patients with IdiopathicPulmonary Fibrosis | Idiopathic Pulmonary Fibrosis MedDRA version: 18.0;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: BIBF 1120 Product Code: BIBF 1120 Product Name: BIBF 1120 Product Code: BIBF 1120 Product Name: BIBF 1120 Product Code: BIBF 1120 | Boehringer Ingelheim Pharma GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 300 | Phase 2 | Portugal;Greece;Spain;Ireland;Russian Federation;Chile;United Kingdom;Italy;France;Hungary;Czech Republic;Mexico;Canada;Argentina;Belgium;Brazil;Australia;Bulgaria;Netherlands;Germany;China;Korea, Republic of | ||
| 449 | EUCTR2009-013788-21-PT (EUCTR) | 10/05/2010 | 18/03/2010 | A phase II open label, roll over study of the long term tolerability,safety and efficacy of oral BIBF 1120 in patients with IdiopathicPulmonary Fibrosis | A phase II open label, roll over study of the long term tolerability,safety and efficacy of oral BIBF 1120 in patients with IdiopathicPulmonary Fibrosis | Idiopathic Pulmonary Fibrosis MedDRA version: 17.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders | Product Name: BIBF 1120 Product Code: BIBF 1120 Product Name: BIBF 1120 Product Code: BIBF 1120 Product Name: BIBF 1120 Product Code: BIBF 1120 | Unilfarma, Lda. | NULL | Not Recruiting | Female: yes Male: yes | 300 | Phase 2 | France;Portugal;Czech Republic;Hungary;Greece;Belgium;Spain;Ireland;Bulgaria;Germany;United Kingdom;Italy | ||
| 450 | NCT01136174 (ClinicalTrials.gov) | May 2010 | 31/5/2010 | Safety and PK Study of BIBF 1120 in Japanese Patients With IPF | A Double-blind, Randomised, Placebo-controlled (Within a Dose Group) Study to Evaluate Safety and Pharmacokinetics of Multiple Rising Doses of BIBF 1120 at 50 mg Bid (14 Days), 100 mg Bid (14 Days), and 150 mg Bid (28 Days) p.o., on Top of Standard Medical Care With Stratification According to Pirfenidone Use, in Japanese Patients With Idiopathic Pulmonary Fibrosis. | Idiopathic Pulmonary Fibrosis | Drug: Placebo;Drug: BIBF 1120 | Boehringer Ingelheim | NULL | Completed | 40 Years | N/A | All | 50 | Phase 2 | Japan |
| 451 | EUCTR2009-013788-21-ES (EUCTR) | 28/04/2010 | 23/02/2010 | Ensayo clínico de Fase II, abierto, y de extensión para evaluar la tolerabilidad a largo plazo, la seguridad y la eficacia de BIBF 1120 administrado por vía oral en pacientes con Fibrosis Pulmonar IdiopáticaA phase II open label, roll over study of the long term tolerability,safety and efficacy of oral BIBF 1120 in patients with IdiopathicPulmonary Fibrosis | Ensayo clínico de Fase II, abierto, y de extensión para evaluar la tolerabilidad a largo plazo, la seguridad y la eficacia de BIBF 1120 administrado por vía oral en pacientes con Fibrosis Pulmonar IdiopáticaA phase II open label, roll over study of the long term tolerability,safety and efficacy of oral BIBF 1120 in patients with IdiopathicPulmonary Fibrosis | Fibrosis Pulmonar Idiopática MedDRA version: 12.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis | Product Name: BIBF 1120 Product Code: BIBF 1120 Product Name: BIBF 1120 Product Code: BIBF 1120 Product Name: BIBF 1120 Product Code: BIBF 1120 | Boehringer Ingelheim España S.A. | NULL | Not Recruiting | Female: yes Male: yes | 300 | Phase 2 | Portugal;France;Czech Republic;Hungary;Greece;Belgium;Spain;Ireland;Bulgaria;Germany;United Kingdom;Italy | ||
| 452 | EUCTR2009-013788-21-BE (EUCTR) | 22/04/2010 | 08/03/2010 | A phase II open label, roll over study of the long term tolerability,safety and efficacy of oral BIBF 1120 in patients with IdiopathicPulmonary Fibrosis | A phase II open label, roll over study of the long term tolerability,safety and efficacy of oral BIBF 1120 in patients with IdiopathicPulmonary Fibrosis | Idiopathic Pulmonary Fibrosis MedDRA version: 17.0;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders | Product Name: BIBF 1120 Product Code: BIBF 1120 Product Name: BIBF 1120 Product Code: BIBF 1120 Product Name: BIBF 1120 Product Code: BIBF 1120 | SCS Boehringer Ingelheim Comm.V | NULL | Not Recruiting | Female: yes Male: yes | 300 | Phase 2 | Portugal;France;Czech Republic;Hungary;Greece;Spain;Belgium;Ireland;Bulgaria;Germany;United Kingdom;Italy | ||
| 453 | EUCTR2009-013788-21-FR (EUCTR) | 09/04/2010 | 08/03/2010 | A phase II open label, roll over study of the long term tolerability,safety and efficacy of oral BIBF 1120 in patients with IdiopathicPulmonary Fibrosis | A phase II open label, roll over study of the long term tolerability,safety and efficacy of oral BIBF 1120 in patients with IdiopathicPulmonary Fibrosis | Idiopathic Pulmonary Fibrosis MedDRA version: 12.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis | Product Name: BIBF 1120 Product Code: BIBF 1120 Product Name: BIBF 1120 Product Code: BIBF 1120 Product Name: BIBF 1120 Product Code: BIBF 1120 | Boehringer Ingelheim France | NULL | Not Recruiting | Female: yes Male: yes | 300 | Phase 2 | Portugal;France;Czech Republic;Hungary;Greece;Belgium;Spain;Ireland;Bulgaria;Germany;United Kingdom;Italy | ||
| 454 | EUCTR2009-013788-21-IT (EUCTR) | 07/04/2010 | 26/03/2010 | A phase II open label, roll over study of the long term tolerability, safety and efficacy of oral BIBF 1120 in patients with Idiopathic Pulmonary Fibrosis - ND | A phase II open label, roll over study of the long term tolerability, safety and efficacy of oral BIBF 1120 in patients with Idiopathic Pulmonary Fibrosis - ND | Idiopathic Pulmonary Fibrosis MedDRA version: 9.1;Level: LLT;Classification code 10021240 | Product Code: BIBF 1120 Product Code: BIBF 1120 Product Code: BIBF 1120 | BOEHRINGER ING. | NULL | Not Recruiting | Female: yes Male: yes | 350 | Phase 2 | Portugal;France;Czech Republic;Hungary;Greece;Belgium;Spain;Ireland;Bulgaria;Germany;United Kingdom;Italy | ||
| 455 | EUCTR2008-006054-17-IT (EUCTR) | 26/01/2010 | 22/10/2009 | A double-blind, randomized, placebo-controlled, multicenter, parallel group study to evaluate the efficacy, safety, and tolerability of macitentan in patients with idiopathic pulmonary fibrosis. - MUSIC | A double-blind, randomized, placebo-controlled, multicenter, parallel group study to evaluate the efficacy, safety, and tolerability of macitentan in patients with idiopathic pulmonary fibrosis. - MUSIC | Idiopathic Pulmonary Fibrosis MedDRA version: 9.1;Level: LLT;Classification code 10021240 | Product Name: Macitentan Product Code: ACT-064992 INN or Proposed INN: Macitentan | Actelion Pharamceuticals Ltd | NULL | Not Recruiting | Female: yes Male: yes | 156 | Germany;Slovenia;France;Spain;Italy;Sweden | |||
| 456 | EUCTR2009-011169-98-AT (EUCTR) | 26/11/2009 | 25/08/2009 | ARTEMIS-PH: A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multi-Center, Parallel-Group Study to Evaluate the Efficacy and Safety of Ambrisentan in Subjects with Idiopathic Pulmonary Fibrosis and Pulmonary Hypertension - ARTEMIS-PH | ARTEMIS-PH: A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multi-Center, Parallel-Group Study to Evaluate the Efficacy and Safety of Ambrisentan in Subjects with Idiopathic Pulmonary Fibrosis and Pulmonary Hypertension - ARTEMIS-PH | Pulmonary Hypertension associated with Idiopathic Pulmonary Fibrosis MedDRA version: 12.0;Level: LLT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis MedDRA version: 12.0;Classification code 10037400;Term: Pulmonary hypertension | Trade Name: Letairis INN or Proposed INN: Ambrisentan Trade Name: Letairis INN or Proposed INN: Ambrisentan | Gilead Sciences, Inc | NULL | Not Recruiting | Female: yes Male: yes | 225 | Phase 3 | Czech Republic;United Kingdom;Germany;Italy;Austria | ||
| 457 | EUCTR2009-011169-98-DE (EUCTR) | 03/11/2009 | 06/08/2009 | ARTEMIS-PH: A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multi-Center, Parallel-Group Study to Evaluate the Efficacy and Safety of Ambrisentan in Subjects with Idiopathic Pulmonary Fibrosis and Pulmonary Hypertension - ARTEMIS-PH | ARTEMIS-PH: A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multi-Center, Parallel-Group Study to Evaluate the Efficacy and Safety of Ambrisentan in Subjects with Idiopathic Pulmonary Fibrosis and Pulmonary Hypertension - ARTEMIS-PH | Pulmonary Hypertension associated with Idiopathic Pulmonary Fibrosis MedDRA version: 12.0;Level: LLT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis MedDRA version: 12.0;Classification code 10037400;Term: Pulmonary hypertension | Trade Name: Letairis INN or Proposed INN: Ambrisentan Trade Name: Letairis INN or Proposed INN: Ambrisentan | Gilead Sciences, Inc | NULL | Not Recruiting | Female: yes Male: yes | 225 | Phase 3 | Czech Republic;United Kingdom;Germany;Italy;Austria | ||
| 458 | EUCTR2009-011169-98-GB (EUCTR) | 30/10/2009 | 01/09/2009 | ARTEMIS-PH: A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multi-Center, Parallel-Group Study to Evaluate the Efficacy and Safety of Ambrisentan in Subjects with Idiopathic Pulmonary Fibrosis and Pulmonary Hypertension - ARTEMIS-PH | ARTEMIS-PH: A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multi-Center, Parallel-Group Study to Evaluate the Efficacy and Safety of Ambrisentan in Subjects with Idiopathic Pulmonary Fibrosis and Pulmonary Hypertension - ARTEMIS-PH | Pulmonary Hypertension associated with Idiopathic Pulmonary Fibrosis MedDRA version: 12.0;Level: LLT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis MedDRA version: 12.0;Classification code 10037400;Term: Pulmonary hypertension | Trade Name: Letairis INN or Proposed INN: Ambrisentan Trade Name: Letairis INN or Proposed INN: Ambrisentan | Gilead Sciences, Inc | NULL | Not Recruiting | Female: yes Male: yes | 225 | Phase 3 | Czech Republic;Germany;United Kingdom;Italy;Austria | ||
| 459 | JPRN-UMIN000016045 | 2009/10/03 | 26/12/2014 | A case-control study evaluating the efficacy and safety of combined therapy with pirfenidone and inhaled N-acetylcysteine for idiopathic pulmonary fibrosis. | A case-control study evaluating the efficacy and safety of combined therapy with pirfenidone and inhaled N-acetylcysteine for idiopathic pulmonary fibrosis. - Combined therapy with pirfenidone and inhaled N-acetylcysteine for idiopathic pulmonary fibrosis. | Idiopathic pulmonary fibrosis | Using Micro Air nebulizers and vibration mesh technology (NE-U07, Omron, Tokyo, Japan), patients receiving NAC combined with pirfenidone were treated twice daily with 352.4 mg of inhaled NAC, which was diluted with saline to a total volume of 6 mL for 48 weeks. Pirfenidone 1200-1800mg (control group) | Department of Respiratory Medicine, Toho University Omori Medical Center, Tokyo | ,NULL | Complete: follow-up complete | 20years-old | Not applicable | Male and Female | 20 | Not selected | Japan |
| 460 | EUCTR2009-011169-98-IT (EUCTR) | 22/09/2009 | 21/09/2009 | A Phase 3, Randomized, Double Blind, Placebo Controlled, Multi Center, Parallel Group Study to Evaluate the Efficacy and Safety of Ambrisentan in Subjects with Idiopathic Pulmonary Fibrosis and Pulmonary Hypertension - ND | A Phase 3, Randomized, Double Blind, Placebo Controlled, Multi Center, Parallel Group Study to Evaluate the Efficacy and Safety of Ambrisentan in Subjects with Idiopathic Pulmonary Fibrosis and Pulmonary Hypertension - ND | Idiopathic Pulmonary Fibrosis and Pulmonary Hypertension MedDRA version: 9.1;Level: LLT;Classification code 10021240 MedDRA version: 9.1;Classification code 10037400 | Trade Name: Letairis Trade Name: Letairis | Gilead Sciences Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 225 | Phase 3 | Czech Republic;United Kingdom;Germany;Italy;Austria | ||
| 461 | EUCTR2008-004405-34-IE (EUCTR) | 08/09/2009 | 07/01/2009 | A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multi-Center, Parallel-Group, Event-Driven Study to Evaluate the Efficacy and Safety of Ambrisentan in Subjects with Idiopathic Pulmonary Fibrosis (IPF) - ARTEMIS | A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multi-Center, Parallel-Group, Event-Driven Study to Evaluate the Efficacy and Safety of Ambrisentan in Subjects with Idiopathic Pulmonary Fibrosis (IPF) - ARTEMIS | Idiopathic pulmonary fibrosis (IPF) MedDRA version: 9.1;Level: LLT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis | Trade Name: Letairis 5 mg INN or Proposed INN: Ambrisentan Trade Name: Letairis 10 mg INN or Proposed INN: Ambrisentan | Gilead Sciences Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 600 | Phase 3 | United Kingdom;Germany;Czech Republic;Netherlands;Belgium;France;Spain;Ireland;Italy;Austria | ||
| 462 | EUCTR2008-006054-17-SE (EUCTR) | 12/08/2009 | 25/06/2009 | A double-blind, randomized, placebo-controlled, multicenter, parallel group study to evaluate the efficacy, safety, and tolerability of macitentan in patients with idiopathic pulmonary fibrosis - MUSIC | A double-blind, randomized, placebo-controlled, multicenter, parallel group study to evaluate the efficacy, safety, and tolerability of macitentan in patients with idiopathic pulmonary fibrosis - MUSIC | To evaluate the efficacy, safety, and tolerabilitiy of macitentan in patients with idiopathic pulmonary fibrosis. MedDRA version: 9.1;Level: LLT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis | Product Name: macitentan Product Code: ACT-064992 INN or Proposed INN: macitentan | Actelion Pharmaceuticals Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 156 | Germany;Slovenia;France;Spain;Italy;Sweden | |||
| 463 | EUCTR2008-004405-34-IT (EUCTR) | 03/08/2009 | 27/07/2009 | A Phase 3, Randomized, Double-blind, Placebo-controlled, Multi-Center, Parallel-Group, Event-Driven Study to Evaluate the Efficacy and Safety of Ambrisentan in subjects with Early Idiopathic Pulmonary Fibrosis (IPF) - ARTEMIS-IPF | A Phase 3, Randomized, Double-blind, Placebo-controlled, Multi-Center, Parallel-Group, Event-Driven Study to Evaluate the Efficacy and Safety of Ambrisentan in subjects with Early Idiopathic Pulmonary Fibrosis (IPF) - ARTEMIS-IPF | Idiopathic pulmonary fibrosis MedDRA version: 12.0;Level: LLT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis | Trade Name: VOLIBRIS INN or Proposed INN: Ambrisentan Trade Name: VOLIBRIS INN or Proposed INN: Ambrisentan | Gilead Sciences Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 600 | Phase 3 | United Kingdom;Germany;Czech Republic;Netherlands;Belgium;France;Spain;Ireland;Italy;Austria | ||
| 464 | NCT00879229 (ClinicalTrials.gov) | July 2009 | 8/4/2009 | ARTEMIS-PH - Study of Ambrisentan in Subjects With Pulmonary Hypertension Associated With Idiopathic Pulmonary Fibrosis | A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multi-Center, Parallel-Group Study to Evaluate the Efficacy and Safety of Ambrisentan in Subjects With Idiopathic Pulmonary Fibrosis and Pulmonary Hypertension | Idiopathic Pulmonary Fibrosis;Pulmonary Hypertension | Drug: Ambrisentan;Drug: Placebo | Gilead Sciences | NULL | Terminated | 35 Years | 80 Years | All | 40 | Phase 3 | United States;Australia;Austria;Canada;Germany;Italy;United Kingdom;Belgium;Ireland;Israel |
| 465 | EUCTR2008-004405-34-GB (EUCTR) | 08/06/2009 | 28/04/2009 | ARTEMIS-IPF: A Phase 3, Randomized, Double Blind, Placebo Controlled, Multi Center, Parallel Group, Event Driven Study to Evaluate the Efficacy and Safety of Ambrisentan in Subjects with Early Idiopathic Pulmonary Fibrosis (IPF) - ARTEMIS-IPF | ARTEMIS-IPF: A Phase 3, Randomized, Double Blind, Placebo Controlled, Multi Center, Parallel Group, Event Driven Study to Evaluate the Efficacy and Safety of Ambrisentan in Subjects with Early Idiopathic Pulmonary Fibrosis (IPF) - ARTEMIS-IPF | Idiopathic pulmonary fibrosis (IPF) MedDRA version: 9.1;Level: LLT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis | Trade Name: Letairis 5 mg INN or Proposed INN: Ambrisentan Trade Name: Letairis 10 mg INN or Proposed INN: Ambrisentan | Gilead Sciences Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 660 | Phase 3 | Germany;Czech Republic;United Kingdom;Netherlands;Belgium;France;Spain;Ireland;Italy;Austria | ||
| 466 | EUCTR2008-004405-34-NL (EUCTR) | 04/06/2009 | 10/03/2009 | A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multi-Center, Parallel-Group, Event-Driven Study to Evaluate the Efficacy and Safety of Ambrisentan in Subjects with Early Idiopathic Pulmonary Fibrosis (IPF) - ARTEMIS-IPF | A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multi-Center, Parallel-Group, Event-Driven Study to Evaluate the Efficacy and Safety of Ambrisentan in Subjects with Early Idiopathic Pulmonary Fibrosis (IPF) - ARTEMIS-IPF | Idiopathic pulmonary fibrosis (IPF) MedDRA version: 9.1;Level: LLT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis | Trade Name: Letairis 5 mg INN or Proposed INN: Ambrisentan Trade Name: Letairis 10 mg INN or Proposed INN: Ambrisentan | Gilead Sciences Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 660 | Phase 3 | France;Czech Republic;Spain;Belgium;Ireland;Austria;Germany;Netherlands;Italy;United Kingdom | ||
| 467 | JPRN-UMIN000007663 | 2009/06/01 | 05/04/2012 | Efficacy of inhaled N-acetylcysteine(NAC) on lung function and redox balance in idiopathic pulmonary fibrosis(IPF). | Efficacy of inhaled N-acetylcysteine(NAC) on lung function and redox balance in idiopathic pulmonary fibrosis(IPF). - Efficacy of inhaled NAC in IPF. | Idiopathic pulmonary fibrosis | inhaled NAC mono-therapy | Toho University Omori Medical CenterDepartment of Respiratory Medicine | NULL | Complete: follow-up complete | 50years-old | 80years-old | Male and Female | 50 | Not selected | Japan |
| 468 | EUCTR2008-006054-17-ES (EUCTR) | 20/05/2009 | 01/04/2009 | Estudio multicéntrico, aleatorizado, de grupos paralelos, doble ciego, controlado con placebo para evaluar la eficacia, seguridad y tolerabilidad de Macitentan en pacientes con Fibrosis Pulmonar Idiopática.A double-blind, randomized, placebo-controlled, multicenter, parallel group study to evaluate the efficacy, safety, and tolerability of macitentan in patients with idiopathic pulmonary fibrosis. - MUSIC | Estudio multicéntrico, aleatorizado, de grupos paralelos, doble ciego, controlado con placebo para evaluar la eficacia, seguridad y tolerabilidad de Macitentan en pacientes con Fibrosis Pulmonar Idiopática.A double-blind, randomized, placebo-controlled, multicenter, parallel group study to evaluate the efficacy, safety, and tolerability of macitentan in patients with idiopathic pulmonary fibrosis. - MUSIC | Evaluar la eficacia, seguridad y tolerabilidad de Macitentan en pacientes con Fibrosis Pulmonar Idiopática. MedDRA version: 9.1;Level: LLT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis | Product Name: Macitentan Product Code: ACT-064992 INN or Proposed INN: Macitentan | Actelion Pharmaceuticals Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 156 | Phase 2 | France;Slovenia;Spain;Germany;Italy;Sweden | ||
| 469 | NCT00903331 (ClinicalTrials.gov) | May 2009 | 14/5/2009 | Macitentan Use in an Idiopathic Pulmonary Fibrosis Clinical Study | A Double-blind, Randomized, Placebo-controlled, Multicenter, Parallel Group Study to Evaluate the Efficacy, Safety, and Tolerability of Macitentan in Patients With Idiopathic Pulmonary Fibrosis | Idiopathic Pulmonary Fibrosis | Drug: ACT-064992 (macitentan);Drug: Placebo | Actelion | NULL | Completed | 18 Years | N/A | All | 178 | Phase 2 | United States;Australia;Canada;France;Germany;Israel;Italy;Slovenia;South Africa;Spain;Sweden;Turkey |
| 470 | EUCTR2008-006054-17-FR (EUCTR) | 29/04/2009 | 25/03/2009 | MUSIC: Macitentan USe in an Idiopathic pulmonary fibrosis Clinical studyA double-blind, randomized, placebo-controlled, multicenter, parallel group studyto evaluate the efficacy, safety, and tolerability of macitentan in patients withidiopathic pulmonary fibrosis - MUSIC | MUSIC: Macitentan USe in an Idiopathic pulmonary fibrosis Clinical studyA double-blind, randomized, placebo-controlled, multicenter, parallel group studyto evaluate the efficacy, safety, and tolerability of macitentan in patients withidiopathic pulmonary fibrosis - MUSIC | to evaluate the efficacy, safety, and tolerability of macitentan in patients with idiopathic pulmonary fibrosis | Product Name: ACT-064992 Product Code: ACT-064992 INN or Proposed INN: MACITENTAN | Actelion Pharmaceuticals Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 156 | Phase 2 | France;Slovenia;Spain;Germany;Italy;Sweden | ||
| 471 | EUCTR2008-001281-86-BE (EUCTR) | 24/04/2009 | 15/10/2008 | A Phase 2, Multicenter, Multinational, Randomized, Double-blind, Placebo-controlled, Parallel-group, Dose-ranging Study Evaluating the Efficacy and Safety of CNTO 888 Administered Intravenously in Subjects with Idiopathic Pulmonary Fibrosis | A Phase 2, Multicenter, Multinational, Randomized, Double-blind, Placebo-controlled, Parallel-group, Dose-ranging Study Evaluating the Efficacy and Safety of CNTO 888 Administered Intravenously in Subjects with Idiopathic Pulmonary Fibrosis | Idiopathic pulmonary fibrosis (IPF) MedDRA version: 9.1;Level: LLT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis | Product Name: CNTO888 Product Code: CNTO888 | Janssen Biologics B.V. | NULL | Not Recruiting | Female: yes Male: yes | 120 | Phase 2 | Belgium;Germany;Netherlands | ||
| 472 | EUCTR2007-001741-18-AT (EUCTR) | 02/04/2009 | 07/04/2008 | Open-label extension study in patients with Idiopathic Pulmonary Fibrosis who completed protocol AC-052-321 / BUILD 3 - BUILD-3-OL | Open-label extension study in patients with Idiopathic Pulmonary Fibrosis who completed protocol AC-052-321 / BUILD 3 - BUILD-3-OL | Idiopathic Pulmonary Fibrosis (IPF) MedDRA version: 9.1;Level: LLT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis | Trade Name: Tracleer Product Name: Bosentan Product Code: Ro 47-0203 INN or Proposed INN: BOSENTAN Other descriptive name: Tracleer Trade Name: Tracleer Product Name: Bosentan Product Code: Ro 47-0203 INN or Proposed INN: BOSENTAN Other descriptive name: Tracleer | Actelion Pharmaceuticals Ltd | NULL | Not Recruiting | Female: yes Male: yes | 390 | Germany;Czech Republic;United Kingdom;Netherlands;Belgium;France;Ireland;Spain;Italy;Austria | |||
| 473 | EUCTR2008-006054-17-SI (EUCTR) | 31/03/2009 | 06/04/2009 | A double-blind, randomized, placebo-controlled, multicenter, parallel group study to evaluate the efficacy, safety, and tolerability of macitentan in patients with idiopathic pulmonary fibrosis - MUSIC | A double-blind, randomized, placebo-controlled, multicenter, parallel group study to evaluate the efficacy, safety, and tolerability of macitentan in patients with idiopathic pulmonary fibrosis - MUSIC | To evaluate the efficacy, safety, and tolerabilitiy of macitentan in patients with idiopathic pulmonary fibrosis. MedDRA version: 9.1;Level: LLT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis | Product Name: Macitentan Product Code: ACT-064992 INN or Proposed INN: Macitentan | Actelion Pharmaceuticals Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 156 | Germany;Slovenia;France;Spain;Italy;Sweden | |||
| 474 | EUCTR2008-004405-34-ES (EUCTR) | 27/03/2009 | 28/01/2009 | ARTEMIS: A Phase 3, Randomized, Double-Blind,Placebo-Controlled, Multi-Center, Parallel-Group,Event-Driven Study to Evaluate the Efficacy and Safety ofAmbrisentan in Subjects with Early Idiopathic PulmonaryFibrosis (IPF)ARTEMIS: Estudio de fase 3, aleatorizado, doble ciego, controlado con placebo, multicéntrico, con grupos paralelos, en función de eventos, para evaluar la eficacia y seguridad de ambrisentan en sujetos con fibrosis pulmonar idiopática temprana (FPI). - ARTEMIS | ARTEMIS: A Phase 3, Randomized, Double-Blind,Placebo-Controlled, Multi-Center, Parallel-Group,Event-Driven Study to Evaluate the Efficacy and Safety ofAmbrisentan in Subjects with Early Idiopathic PulmonaryFibrosis (IPF)ARTEMIS: Estudio de fase 3, aleatorizado, doble ciego, controlado con placebo, multicéntrico, con grupos paralelos, en función de eventos, para evaluar la eficacia y seguridad de ambrisentan en sujetos con fibrosis pulmonar idiopática temprana (FPI). - ARTEMIS | Idiopathic Pulmonary Fibrosis (IPF)fibrosis pulmonar idiopática temprana (FPI) MedDRA version: 9.1;Level: LLT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis | Trade Name: Letairis 5 mg INN or Proposed INN: Ambrisentan Trade Name: Letairis 10 mg INN or Proposed INN: Ambrisentan | Gilead Sciences Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 600 | Phase 3 | United Kingdom;Germany;Czech Republic;Netherlands;Belgium;France;Ireland;Spain;Italy;Austria | ||
| 475 | EUCTR2008-004405-34-AT (EUCTR) | 13/03/2009 | 21/01/2009 | A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multi-Center, Parallel-Group, Event-Driven Study to Evaluate the Efficacy and Safety of Ambrisentan in Subjects with Idiopathic Pulmonary Fibrosis (IPF) - ARTEMIS | A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multi-Center, Parallel-Group, Event-Driven Study to Evaluate the Efficacy and Safety of Ambrisentan in Subjects with Idiopathic Pulmonary Fibrosis (IPF) - ARTEMIS | Idiopathic pulmonary fibrosis (IPF) MedDRA version: 9.1;Level: LLT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis | Trade Name: Letairis 5 mg INN or Proposed INN: Ambrisentan Trade Name: Letairis 10 mg INN or Proposed INN: Ambrisentan | Gilead Sciences Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 600 | Phase 3 | United Kingdom;Germany;Czech Republic;Netherlands;Belgium;France;Spain;Ireland;Italy;Austria | ||
| 476 | EUCTR2008-004405-34-BE (EUCTR) | 09/03/2009 | 22/01/2009 | A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multi-Center, Parallel-Group, Event-Driven Study to Evaluate the Efficacy and Safety of Ambrisentan in Subjects with Early Idiopathic Pulmonary Fibrosis (IPF) - ARTEMIS-IPF | A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multi-Center, Parallel-Group, Event-Driven Study to Evaluate the Efficacy and Safety of Ambrisentan in Subjects with Early Idiopathic Pulmonary Fibrosis (IPF) - ARTEMIS-IPF | Idiopathic pulmonary fibrosis (IPF) MedDRA version: 9.1;Level: LLT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis | Trade Name: Letairis 5 mg INN or Proposed INN: Ambrisentan Trade Name: Letairis 10 mg INN or Proposed INN: Ambrisentan | Gilead Sciences Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 660 | Phase 3 | United Kingdom;Germany;Czech Republic;Netherlands;Belgium;France;Spain;Ireland;Italy;Austria | ||
| 477 | NCT00879879 (ClinicalTrials.gov) | March 2009 | 10/4/2009 | Losartan in Treating Patients With Idiopathic Pulmonary Fibrosis | Treatment of Idiopathic Pulmonary Fibrosis With Losartan: A Pilot Project | Precancerous Condition | Drug: losartan | University of South Florida | National Cancer Institute (NCI) | Completed | 21 Years | N/A | All | 20 | N/A | United States |
| 478 | EUCTR2008-004405-34-FR (EUCTR) | 09/02/2009 | 16/03/2009 | A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multi-Center, Parallel-Group, Event-Driven Study to Evaluate the Efficacy and Safety of Ambrisentan in Subjects with Idiopathic Pulmonary Fibrosis (IPF) - ARTEMIS | A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multi-Center, Parallel-Group, Event-Driven Study to Evaluate the Efficacy and Safety of Ambrisentan in Subjects with Idiopathic Pulmonary Fibrosis (IPF) - ARTEMIS | Idiopathic pulmonary fibrosis (IPF) MedDRA version: 9.1;Level: LLT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis | Trade Name: Letairis 5 mg INN or Proposed INN: Ambrisentan Trade Name: Letairis 10 mg INN or Proposed INN: Ambrisentan | Gilead Sciences Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 600 | Phase 3 | France;Czech Republic;Spain;Belgium;Ireland;Austria;Netherlands;Germany;Italy;United Kingdom | ||
| 479 | EUCTR2008-007168-40-IT (EUCTR) | 20/01/2009 | 09/03/2009 | Use of 68Ga-DOTA-NOC for the evaluation of patients with Idiopathic pulmonary fibrosisSTUDY CODE: 68Ga-DOTA-NOC/ILD 01/2008 - 68Ga-DOTA-NOC/ILD01/2008 | Use of 68Ga-DOTA-NOC for the evaluation of patients with Idiopathic pulmonary fibrosisSTUDY CODE: 68Ga-DOTA-NOC/ILD 01/2008 - 68Ga-DOTA-NOC/ILD01/2008 | patients with Idiopathic pulmonary fibrosis MedDRA version: 9.1;Level: LLT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis | Product Name: Gallium68-Dota-Noc | AZIENDA OSPEDALIERA DI BOLOGNA POLICLINICO S. ORSOLA M. MALPIGHI | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | Italy | ||||
| 480 | EUCTR2008-001281-86-NL (EUCTR) | 14/01/2009 | 25/09/2008 | A Phase 2, Multicenter, Multinational, Randomized, Double-blind, Placebo-controlled, Parallel-group, Dose-ranging Study Evaluating the Efficacy and Safety of CNTO 888 Administered Intravenously in Subjects with Idiopathic Pulmonary Fibrosis | A Phase 2, Multicenter, Multinational, Randomized, Double-blind, Placebo-controlled, Parallel-group, Dose-ranging Study Evaluating the Efficacy and Safety of CNTO 888 Administered Intravenously in Subjects with Idiopathic Pulmonary Fibrosis | Idiopathic pulmonary fibrosis (IPF) MedDRA version: 9.1;Level: LLT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis | Product Name: CNTO888 Product Code: CNTO888 | Centocor B.V. | NULL | Not Recruiting | Female: yes Male: yes | 120 | Phase 2 | Germany;Netherlands;Belgium | ||
| 481 | JPRN-UMIN000025256 | 2009/01/01 | 13/12/2016 | Benefits of supplemental oxygen on exercise capacity and dyspnea in IPF patients | Benefits of supplemental oxygen on exercise capacity and dyspnea in IPF patients - Benefits of supplemental oxygen on exercise capacity and dyspnea in IPF patients | idiopathic pulmonary fibrosis | oxygen gas air gas | Tosei General Hospital | NULL | Complete: follow-up complete | Not applicable | 75years-old | Male and Female | 106 | Not applicable | Japan |
| 482 | NCT00768300 (ClinicalTrials.gov) | December 2008 | 7/10/2008 | (ARTEMIS-IPF) Randomized, Placebo-Controlled Study to Evaluate Safety and Effectiveness of Ambrisentan in IPF | ARTEMIS-IPF: A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multi-Center, Parallel-Group, Event Driven Study to Evaluate the Efficacy and Safety of Ambrisentan in Subjects With Early Idiopathic Pulmonary Fibrosis (IPF) | Idiopathic Pulmonary Fibrosis | Drug: Ambrisentan;Drug: Placebo | Gilead Sciences | NULL | Terminated | 40 Years | 80 Years | All | 494 | Phase 3 | United States;Argentina;Australia;Austria;Belgium;Brazil;Canada;Chile;Colombia;Czech Republic;France;Germany;Ireland;Israel;Italy;Mexico;Netherlands;Peru;Poland;Spain;Switzerland;United Kingdom |
| 483 | NCT00786201 (ClinicalTrials.gov) | December 2008 | 4/11/2008 | A Study to Evaluate the Safety and Effectiveness of CNTO 888 Administered Intravenously (IV) in Participants With Idiopathic Pulmonary Fibrosis (IPF) | A Phase 2, Multicenter, Multinational, Randomized, Double-blind, Placebo-controlled, Parallel-group, Dose-ranging Study Evaluating the Efficacy and Safety of CNTO 888 Administered Intravenously in Subjects With Idiopathic Pulmonary Fibrosis | Pulmonary Fibrosis | Drug: Placebo;Drug: CNTO 888 1 mg/kg;Drug: CNTO 888 5 mg/kg;Drug: CNTO 888 15 mg/kg | Centocor, Inc. | NULL | Completed | 40 Years | 80 Years | Both | 126 | Phase 2 | United States;Belgium;Canada;Germany;Netherlands |
| 484 | EUCTR2007-001741-18-NL (EUCTR) | 17/09/2008 | 30/05/2008 | Open-label extension study in patients with Idiopathic Pulmonary Fibrosis who completed protocol AC-052-321 / BUILD 3 - BUILD-3-OL | Open-label extension study in patients with Idiopathic Pulmonary Fibrosis who completed protocol AC-052-321 / BUILD 3 - BUILD-3-OL | Idiopathic Pulmonary Fibrosis (IPF) MedDRA version: 9.1;Level: LLT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis | Trade Name: Tracleer Product Name: Bosentan Product Code: Ro 47-0203 INN or Proposed INN: BOSENTAN Other descriptive name: Tracleer Trade Name: Tracleer Product Name: Bosentan Product Code: Ro 47-0203 INN or Proposed INN: BOSENTAN Other descriptive name: Tracleer | Actelion Pharmaceuticals Ltd | NULL | Not Recruiting | Female: yes Male: yes | 390 | Germany;Czech Republic;United Kingdom;Netherlands;Belgium;France;Ireland;Spain;Italy;Austria | |||
| 485 | NCT00662038 (ClinicalTrials.gov) | August 2008 | 17/4/2008 | Open-Label Study of the Long Term Safety of Pirfenidone in Patients With Idiopathic Pulmonary Fibrosis (IPF) | An Open-Label Extension Study of the Long Term Safety of Pirfenidone in Patients With Idiopathic Pulmonary Fibrosis (IPF) | Idiopathic Pulmonary Fibrosis | Drug: pirfenidone | Genentech, Inc. | Hoffmann-La Roche | Completed | 40 Years | 84 Years | All | 1058 | Phase 3 | United States |
| 486 | EUCTR2007-001741-18-GB (EUCTR) | 25/07/2008 | 11/04/2008 | Open-label extension study in patients with Idiopathic Pulmonary Fibrosis who completed protocol AC-052-321 / BUILD 3 - BUILD-3-OL | Open-label extension study in patients with Idiopathic Pulmonary Fibrosis who completed protocol AC-052-321 / BUILD 3 - BUILD-3-OL | Idiopathic Pulmonary Fibrosis (IPF) MedDRA version: 9.1;Level: LLT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis | Trade Name: Tracleer Product Name: Bosentan Product Code: Ro 47-0203 INN or Proposed INN: BOSENTAN Other descriptive name: Tracleer Trade Name: Tracleer Product Name: Bosentan Product Code: Ro 47-0203 INN or Proposed INN: BOSENTAN Other descriptive name: Tracleer | Actelion Pharmaceuticals Ltd | NULL | Not Recruiting | Female: yes Male: yes | 390 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | France;Czech Republic;Belgium;Spain;Ireland;Austria;Germany;Netherlands;Italy;United Kingdom | ||
| 487 | EUCTR2007-001741-18-IE (EUCTR) | 17/07/2008 | 12/03/2008 | Open-label extension study in patients with Idiopathic Pulmonary Fibrosis who completed protocol AC-052-321 / BUILD 3 - BUILD-3-OL | Open-label extension study in patients with Idiopathic Pulmonary Fibrosis who completed protocol AC-052-321 / BUILD 3 - BUILD-3-OL | Idiopathic Pulmonary Fibrosis (IPF) MedDRA version: 9.1;Level: LLT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis | Trade Name: Tracleer Product Name: Bosentan Product Code: Ro 47-0203 INN or Proposed INN: BOSENTAN Other descriptive name: Tracleer Trade Name: Tracleer Product Name: Bosentan Product Code: Ro 47-0203 INN or Proposed INN: BOSENTAN Other descriptive name: Tracleer | Actelion Pharmaceuticals Ltd | NULL | Not Recruiting | Female: yes Male: yes | 390 | Germany;Czech Republic;United Kingdom;Netherlands;Belgium;France;Spain;Ireland;Italy;Austria | |||
| 488 | NCT00705133 (ClinicalTrials.gov) | July 2008 | 23/6/2008 | Treprostinil Therapy For Patients With Interstitial Lung Disease And Severe Pulmonary Arterial Hypertension | Using Either Intravenous (IV) or Subcutaneous (SQ) Treprostinil to Treat Pulmonary Hypertension Related to Underlying Interstitial Lung Disease | Pulmonary Arterial Hypertension;Interstitial Lung Disease;Idiopathic Pulmonary Fibrosis | Drug: Treprostinil | Rajan Saggar | United Therapeutics | Completed | N/A | N/A | All | 15 | Phase 2 | United States |
| 489 | EUCTR2007-001741-18-FR (EUCTR) | 24/06/2008 | 04/02/2008 | Open-label extension study in patients with Idiopathic Pulmonary Fibrosis who completed protocol AC-052-321 / BUILD 3 - BUILD-3-OL | Open-label extension study in patients with Idiopathic Pulmonary Fibrosis who completed protocol AC-052-321 / BUILD 3 - BUILD-3-OL | Idiopathic Pulmonary Fibrosis (IPF) MedDRA version: 9.1;Level: LLT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis | Trade Name: Tracleer Product Name: Bosentan Product Code: Ro 47-0203 INN or Proposed INN: BOSENTAN Other descriptive name: Tracleer Trade Name: Tracleer Product Name: Bosentan Product Code: Ro 47-0203 INN or Proposed INN: BOSENTAN Other descriptive name: Tracleer | Actelion Pharmaceuticals Ltd | NULL | Not Recruiting | Female: yes Male: yes | 390 | Phase 3 | France;Czech Republic;Belgium;Spain;Ireland;Austria;Germany;Netherlands;Italy;United Kingdom | ||
| 490 | EUCTR2007-001741-18-CZ (EUCTR) | 16/06/2008 | 18/04/2008 | Open-label extension study in patients with Idiopathic Pulmonary Fibrosis who completed protocol AC-052-321 / BUILD 3 - BUILD-3-OL | Open-label extension study in patients with Idiopathic Pulmonary Fibrosis who completed protocol AC-052-321 / BUILD 3 - BUILD-3-OL | Idiopathic Pulmonary Fibrosis (IPF) MedDRA version: 9.1;Level: LLT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis | Trade Name: Tracleer Product Name: Bosentan Product Code: Ro 47-0203 INN or Proposed INN: BOSENTAN Other descriptive name: Tracleer Trade Name: Tracleer Product Name: Bosentan Product Code: Ro 47-0203 INN or Proposed INN: BOSENTAN Other descriptive name: Tracleer | Actelion Pharmaceuticals Ltd | NULL | Not Recruiting | Female: yes Male: yes | 390 | Germany;United Kingdom;Czech Republic;Netherlands;Belgium;France;Ireland;Spain;Italy;Austria | |||
| 491 | EUCTR2007-007800-13-IT (EUCTR) | 11/06/2008 | 02/10/2008 | Studio di estensione in aperto sulla sicurezza a lungo termine del pirfenidone nei pazienti con fibrosi polmonare idiopatica (FPI) che hanno completato gli studi CAPACITY - ND | Studio di estensione in aperto sulla sicurezza a lungo termine del pirfenidone nei pazienti con fibrosi polmonare idiopatica (FPI) che hanno completato gli studi CAPACITY - ND | Idiopathic Pulmonary Fibrosis (IPF) MedDRA version: 9.1;Level: LLT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis | Product Name: Pirfenidone | INTERMUNE | NULL | Not Recruiting | Female: yes Male: yes | 750 | Germany;United Kingdom;Belgium;France;Spain;Ireland;Italy | |||
| 492 | EUCTR2007-007800-13-IE (EUCTR) | 04/06/2008 | 07/02/2008 | An Open-Label Extension Study of the Long-Term Safety of Pirfenidone in Patients with Idiopathic Pulmonary Fibrosis (IPF) Who Complete the CAPACITY Studies - Open-Label Extension of Pirfenidone CAPACITY Studies | An Open-Label Extension Study of the Long-Term Safety of Pirfenidone in Patients with Idiopathic Pulmonary Fibrosis (IPF) Who Complete the CAPACITY Studies - Open-Label Extension of Pirfenidone CAPACITY Studies | Idiopathic Pulmonary Fibrosis (IPF) MedDRA version: 9.1;Level: LLT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis | Product Name: Pirfenidone INN or Proposed INN: Pirfenidone Other descriptive name: PIR, S-7701 | InterMune, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 750 | Phase 3 | France;Belgium;Germany;Italy;United Kingdom;Ireland;Spain | ||
| 493 | EUCTR2007-007800-13-GB (EUCTR) | 03/06/2008 | 08/02/2008 | Open-Label Extension of Pirfenidone CAPACITY Studies | An Open-Label Extension Study of the Long-Term Safety of Pirfenidone in Patients with Idiopathic Pulmonary Fibrosis (IPF) Who Complete the CAPACITY Studies - Open-Label Extension of Pirfenidone CAPACITY Studies | Idiopathic Pulmonary Fibrosis (IPF) MedDRA version: 14.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders ;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: Pirfenidone INN or Proposed INN: Pirfenidone Other descriptive name: PIR, S-7701 | InterMune, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 600 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | France;United States;Canada;Belgium;Spain;Poland;Ireland;Australia;Germany;Italy;United Kingdom | ||
| 494 | NCT00690885 (ClinicalTrials.gov) | June 2008 | 3/6/2008 | Interferon-alpha Treatment of Chronic Cough in Chronic Obstructive Pulmonary Disease and Idiopathic Pulmonary Fibrosis | Evaluation of Natural Human Interferon Alpha Lozenges in the Treatment of Chronic Cough in Patients With Chronic Obstructive Pulmonary Disease (COPD) or Idiopathic Pulmonary Fibrosis (IPF) | Pulmonary Disease, Chronic Obstructive;Pulmonary Fibrosis;Cough | Drug: interferon-alpha lozenges;Drug: placebo lozenges | Amarillo Biosciences, Inc. | Texas Tech University Health Sciences Center | Terminated | 40 Years | N/A | Both | 1 | Phase 2 | United States |
| 495 | EUCTR2007-007800-13-ES (EUCTR) | 26/05/2008 | 01/04/2008 | An Open-Label Extension Study of the Long-Term Safety of Pirfenidone in Patients with Idiopathic Pulmonary Fibrosis (IPF) Who Complete the CAPACITY StudiesEstudio de extensión de etiqueta abierta de la seguridad a largo plazo de pirfenidona en pacientes con fibrosis pulmonar idiopática (FPI) que completan los estudios CAPACITY. - Open-Label Extension of Pirfenidone CAPACITY Studies | An Open-Label Extension Study of the Long-Term Safety of Pirfenidone in Patients with Idiopathic Pulmonary Fibrosis (IPF) Who Complete the CAPACITY StudiesEstudio de extensión de etiqueta abierta de la seguridad a largo plazo de pirfenidona en pacientes con fibrosis pulmonar idiopática (FPI) que completan los estudios CAPACITY. - Open-Label Extension of Pirfenidone CAPACITY Studies | Idiopathic Pulmonary Fibrosis (IPF)Fibrosis pulmonar idiopática MedDRA version: 9.1;Level: LLT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis | Product Name: Pirfenidone INN or Proposed INN: Pirfenidone Other descriptive name: PIR, S-7701 | InterMune, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 750 | Phase 3 | France;Belgium;Spain;Ireland;Germany;Italy;United Kingdom | ||
| 496 | EUCTR2007-007800-13-DE (EUCTR) | 23/05/2008 | 21/02/2008 | An Open-Label Extension Study of the Long-Term Safety of Pirfenidone in Patients with Idiopathic Pulmonary Fibrosis (IPF) Who Complete the CAPACITY Studies - Open-Label Extension of Pirfenidone CAPACITY Studies | An Open-Label Extension Study of the Long-Term Safety of Pirfenidone in Patients with Idiopathic Pulmonary Fibrosis (IPF) Who Complete the CAPACITY Studies - Open-Label Extension of Pirfenidone CAPACITY Studies | Idiopathic Pulmonary Fibrosis (IPF) MedDRA version: 9.1;Level: LLT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis | Product Name: Pirfenidone INN or Proposed INN: Pirfenidone Other descriptive name: PIR, S-7701 | InterMune, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 750 | Phase 3 | France;Spain;Belgium;Ireland;Germany;Italy;United Kingdom | ||
| 497 | EUCTR2007-001741-18-DE (EUCTR) | 23/05/2008 | 03/11/2008 | Open-label extension study in patients with Idiopathic Pulmonary Fibrosis who completed protocol AC-052-321 / BUILD 3 - BUILD-3-OL | Open-label extension study in patients with Idiopathic Pulmonary Fibrosis who completed protocol AC-052-321 / BUILD 3 - BUILD-3-OL | Idiopathic Pulmonary Fibrosis (IPF) MedDRA version: 9.1;Level: LLT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis | Trade Name: Tracleer Product Name: Bosentan Product Code: Ro 47-0203 INN or Proposed INN: BOSENTAN Other descriptive name: Tracleer Trade Name: Tracleer Product Name: Bosentan Product Code: Ro 47-0203 INN or Proposed INN: BOSENTAN Other descriptive name: Tracleer | Actelion Pharmaceuticals Ltd | NULL | Not Recruiting | Female: yes Male: yes | 390 | France;Czech Republic;Belgium;Spain;Ireland;Austria;Netherlands;Germany;Italy;United Kingdom | |||
| 498 | EUCTR2007-007800-13-BE (EUCTR) | 15/05/2008 | 26/03/2008 | An Open-Label Extension Study of the Long-Term Safety of Pirfenidone in Patients with Idiopathic Pulmonary Fibrosis (IPF) Who Complete the CAPACITY Studies - Open-Label Extension of Pirfenidone CAPACITY Studies | An Open-Label Extension Study of the Long-Term Safety of Pirfenidone in Patients with Idiopathic Pulmonary Fibrosis (IPF) Who Complete the CAPACITY Studies - Open-Label Extension of Pirfenidone CAPACITY Studies | Idiopathic Pulmonary Fibrosis (IPF) MedDRA version: 9.1;Level: LLT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis | Product Name: Pirfenidone INN or Proposed INN: Pirfenidone Other descriptive name: PIR, S-7701 | InterMune, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 750 | France;Spain;Belgium;Ireland;Germany;Italy;United Kingdom | |||
| 499 | EUCTR2007-007800-13-FR (EUCTR) | 13/05/2008 | 29/02/2008 | An Open-Label Extension Study of the Long-Term Safety of Pirfenidone in Patients with Idiopathic Pulmonary Fibrosis (IPF) Who Complete the CAPACITY Studies - Open-Label Extension of Pirfenidone CAPACITY Studies | An Open-Label Extension Study of the Long-Term Safety of Pirfenidone in Patients with Idiopathic Pulmonary Fibrosis (IPF) Who Complete the CAPACITY Studies - Open-Label Extension of Pirfenidone CAPACITY Studies | Idiopathic Pulmonary Fibrosis (IPF) MedDRA version: 9.1;Level: LLT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis | Product Name: Pirfenidone INN or Proposed INN: Pirfenidone | InterMune, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 750 | France;Spain;Belgium;Ireland;Germany;Italy;United Kingdom | |||
| 500 | EUCTR2006-002875-42-BG (EUCTR) | 12/05/2008 | 09/05/2008 | A 12 month, double blind, randomized, placebo-controlled trial evaluating the effect of BIBF 1120 administered at oral doses of 50 mg qd, 50 mg bid, 100 mg bid and 150 mg bid on Forced Vital Capacity decline during one year, in patients with Idiopathic Pulmonary Fibrosis, with optional active treatment extension until last patient out. - Effect of orally administered BIBF 1120 on FVC decline in IPF | A 12 month, double blind, randomized, placebo-controlled trial evaluating the effect of BIBF 1120 administered at oral doses of 50 mg qd, 50 mg bid, 100 mg bid and 150 mg bid on Forced Vital Capacity decline during one year, in patients with Idiopathic Pulmonary Fibrosis, with optional active treatment extension until last patient out. - Effect of orally administered BIBF 1120 on FVC decline in IPF | Idiopathic pulmonary fibrosis MedDRA version: 9.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis | Product Name: BIBF 1120 Product Code: BIBF 1120 | Boehringer Ingelheim Pharma Ges mbH | NULL | Not Recruiting | Female: yes Male: yes | 400 | Portugal;Hungary;United Kingdom;Germany;Netherlands;Belgium;France;Bulgaria;Spain;Ireland;Italy;Greece | |||
| 501 | EUCTR2007-001741-18-ES (EUCTR) | 21/04/2008 | 12/02/2008 | Estudio de extensión abierta en pacientes con Fibrosis Pulmonar Idiopática que hayan completado el protocolo AC-052-321 / BUILD 3 - BUILD-3-OL | Estudio de extensión abierta en pacientes con Fibrosis Pulmonar Idiopática que hayan completado el protocolo AC-052-321 / BUILD 3 - BUILD-3-OL | Fibrosis Pulmonar Idiopática (IPF) MedDRA version: 9.1;Level: LLT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis | Trade Name: Tracleer Product Name: Bosentan Product Code: Ro 47-0203 INN or Proposed INN: BOSENTAN Other descriptive name: Tracleer Trade Name: Tracleer Product Name: Bosentan Product Code: Ro 47-0203 INN or Proposed INN: BOSENTAN Other descriptive name: Tracleer | Actelion Pharmaceuticals Ltd | NULL | Not Recruiting | Female: yes Male: yes | 390 | Germany;Czech Republic;United Kingdom;Netherlands;Belgium;France;Ireland;Spain;Italy;Austria | |||
| 502 | NCT00631475 (ClinicalTrials.gov) | April 2008 | 12/2/2008 | Open Label Extension Study in Patients With Idiopathic Pulmonary Fibrosis Who Completed Protocol AC-052-321/ BUILD 3 / NCT00391443 | Open-Label Extension Study in Patients With Idiopathic Pulmonary Fibrosis Who Completed Protocol AC-052-321 (NCT00391443) | Idiopathic Pulmonary Fibrosis | Drug: Bosentan | Actelion | NULL | Completed | 18 Years | N/A | All | 128 | Phase 3 | United States;Australia;Belgium;Canada;Czech Republic;France;Germany;Ireland;Israel;Italy;Japan;Korea, Republic of;Spain;Switzerland;United Kingdom;Austria;Croatia;Former Serbia and Montenegro;Netherlands;Serbia |
| 503 | NCT00637065 (ClinicalTrials.gov) | April 2008 | 10/3/2008 | Bosentan in Pulmonary Hypertension in Interstitial Lung Disease Treatment Study | Use of the Endothelin-1 Antagonist Bosentan in Patients With Established Pulmonary Hypertension and Fibrotic Lung Disease. - A Randomised, Placebo-Controlled, Double-Blinded Study. | Pulmonary Hypertension;Interstitial Lung Disease;Idiopathic Pulmonary Fibrosis;Nonspecific Interstitial Pneumonia | Drug: Bosentan;Drug: Placebo | Royal Brompton & Harefield NHS Foundation Trust | Actelion | Not yet recruiting | 18 Years | 80 Years | Both | 48 | Phase 4 | United Kingdom |
| 504 | EUCTR2007-001741-18-BE (EUCTR) | 20/03/2008 | 14/03/2008 | Open-label extension study in patients with Idiopathic Pulmonary Fibrosis who completed protocol AC-052-321 / BUILD 3 - BUILD-3-OL | Open-label extension study in patients with Idiopathic Pulmonary Fibrosis who completed protocol AC-052-321 / BUILD 3 - BUILD-3-OL | Idiopathic Pulmonary Fibrosis (IPF) MedDRA version: 9.1;Level: LLT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis | Trade Name: Tracleer Product Name: Bosentan Product Code: Ro 47-0203 INN or Proposed INN: BOSENTAN Other descriptive name: Tracleer Trade Name: Tracleer Product Name: Bosentan Product Code: Ro 47-0203 INN or Proposed INN: BOSENTAN Other descriptive name: Tracleer | Actelion Pharmaceuticals Ltd | NULL | Not Recruiting | Female: yes Male: yes | 390 | Germany;Czech Republic;United Kingdom;Netherlands;Belgium;France;Ireland;Spain;Italy;Austria | |||
| 505 | EUCTR2007-001741-18-IT (EUCTR) | 07/03/2008 | 23/03/2009 | Open-label extension study in patients with Idiopathic Pulmonary Fibrosis who completed protocol AC-052-321/BUILD 3 - Build-3 OL | Open-label extension study in patients with Idiopathic Pulmonary Fibrosis who completed protocol AC-052-321/BUILD 3 - Build-3 OL | Idipathic Pulmonary Fibrosis MedDRA version: 9.1;Level: LLT;Classification code 10001892;Term: Alveolitis fibrosing | Trade Name: TRACLEER INN or Proposed INN: Bosentan | Actelion Registration Ltd | NULL | Not Recruiting | Female: yes Male: yes | 390 | Germany;Czech Republic;United Kingdom;Netherlands;Belgium;France;Ireland;Spain;Italy;Austria | |||
| 506 | EUCTR2006-002875-42-GR (EUCTR) | 22/01/2008 | 20/09/2007 | A 12 month, double blind, randomized, placebo-controlled trial evaluating the effect of BIBF 1120 administered at oral doses of 50 mg qd, 50 mg bid, 100 mg bid and 150 mg bid on Forced Vital Capacity decline during one year, in patients with Idiopathic Pulmonary Fibrosis, with optional active treatment extension until last patient out. - Effect of orally administered BIBF 1120 on FVC decline in IPF | A 12 month, double blind, randomized, placebo-controlled trial evaluating the effect of BIBF 1120 administered at oral doses of 50 mg qd, 50 mg bid, 100 mg bid and 150 mg bid on Forced Vital Capacity decline during one year, in patients with Idiopathic Pulmonary Fibrosis, with optional active treatment extension until last patient out. - Effect of orally administered BIBF 1120 on FVC decline in IPF | Idiopathic pulmonary fibrosis MedDRA version: 9.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis | Product Name: BIBF 1120 Product Code: BIBF 1120 | Boehringer Ingelheim | NULL | Not Recruiting | Female: yes Male: yes | 400 | Portugal;Hungary;United Kingdom;Germany;Netherlands;Belgium;Bulgaria;France;Spain;Ireland;Italy;Greece | |||
| 507 | EUCTR2006-002875-42-PT (EUCTR) | 11/01/2008 | 12/09/2007 | A 12 month, double blind, randomized, placebo-controlled trial evaluating the effect of BIBF 1120 administered at oral doses of 50 mg qd, 50 mg bid, 100 mg bid and 150 mg bid on Forced Vital Capacity decline during one year, in patients with Idiopathic Pulmonary Fibrosis, with optional active treatment extension until last patient out. - Effect of orally administered BIBF 1120 on FVC decline in IPF | A 12 month, double blind, randomized, placebo-controlled trial evaluating the effect of BIBF 1120 administered at oral doses of 50 mg qd, 50 mg bid, 100 mg bid and 150 mg bid on Forced Vital Capacity decline during one year, in patients with Idiopathic Pulmonary Fibrosis, with optional active treatment extension until last patient out. - Effect of orally administered BIBF 1120 on FVC decline in IPF | Idiopathic pulmonary fibrosis MedDRA version: 9.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis | Product Name: BIBF 1120 Product Code: BIBF 1120 | Boehringer Ingelheim France | NULL | Not Recruiting | Female: yes Male: yes | 400 | Hungary;Portugal;United Kingdom;Germany;Netherlands;Belgium;Bulgaria;France;Spain;Ireland;Italy;Greece | |||
| 508 | EUCTR2006-002875-42-CZ (EUCTR) | 19/12/2007 | 10/07/2007 | A 12 month, double blind, randomized, placebo-controlled trial evaluating the effect of BIBF 1120 administered at oral doses of 50 mg qd, 50 mg bid, 100 mg bid and 150 mg bid on Forced Vital Capacity decline during one year, in patients with Idiopathic Pulmonary Fibrosis, with optional active treatment extension until last patient out. - Effect of orally administered BIBF 1120 on FVC decline in IPF | A 12 month, double blind, randomized, placebo-controlled trial evaluating the effect of BIBF 1120 administered at oral doses of 50 mg qd, 50 mg bid, 100 mg bid and 150 mg bid on Forced Vital Capacity decline during one year, in patients with Idiopathic Pulmonary Fibrosis, with optional active treatment extension until last patient out. - Effect of orally administered BIBF 1120 on FVC decline in IPF | Idiopathic pulmonary fibrosis MedDRA version: 9.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis | Product Name: BIBF 1120 Product Code: BIBF 1120 | Boehringer Ingelheim Pharma Ges mbH | NULL | Not Recruiting | Female: yes Male: yes | 400 | Portugal;Greece;Spain;Ireland;Italy;United Kingdom;France;Czech Republic;Hungary;Belgium;Bulgaria;Germany;Netherlands | |||
| 509 | EUCTR2007-001645-17-GB (EUCTR) | 04/12/2007 | 10/10/2007 | Prevention of Established Pulmonary Hypertension in High Risk patients with Fibrotic Lung Disease – a double-blinded, randomised, placebo controlled trial with endothelin-1 receptor antagonist therapy - Prevention of Pulmonary Hypertension in Interstitial Lung Disease | Prevention of Established Pulmonary Hypertension in High Risk patients with Fibrotic Lung Disease – a double-blinded, randomised, placebo controlled trial with endothelin-1 receptor antagonist therapy - Prevention of Pulmonary Hypertension in Interstitial Lung Disease | Pulmonary hypertension in patients with interstitial lung disease. Specifically this trial looks at patients who have mild pulmonary hypertension, or are in an at-risk group to developing pulmonary hypertension, in the context of their interstitial lung disease. The interstitial lung diseases addressed include idiopathic pulmonary fibrosis and non-specific interstitial pneumonitis. MedDRA version: 9.1;Level: LLT;Classification code 10064911;Term: Pulmonary arterial hypertension | Trade Name: Tracleer Product Name: Tracleer | Royal Brompton and Harefield NHS Trust | NULL | Not Recruiting | Female: yes Male: yes | United Kingdom | ||||
| 510 | NCT00600028 (ClinicalTrials.gov) | December 2007 | 11/1/2008 | Treatment of Chronic Cough in Idiopathic Pulmonary Fibrosis With Thalidomide | Treatment of Chronic Cough in Idiopathic Pulmonary Fibrosis With Thalidomide | Idiopathic Pulmonary Fibrosis;Cough | Drug: Thalidomide;Drug: Placebo | Johns Hopkins University | NULL | Completed | 50 Years | N/A | All | 25 | Phase 3 | United States |
| 511 | EUCTR2006-002875-42-GB (EUCTR) | 20/11/2007 | 14/10/2010 | A 12 month, double blind, randomized, placebo-controlled trial evaluating the effect of BIBF 1120 administered at oral doses of 50 mg qd, 50 mg bid, 100 mg bid and 150 mg bid on Forced Vital Capacity decline during one year, in patients with Idiopathic Pulmonary Fibrosis, with optional active treatment extension until last patient out. - Effect of orally administered BIBF 1120 on FVC decline in IPF | A 12 month, double blind, randomized, placebo-controlled trial evaluating the effect of BIBF 1120 administered at oral doses of 50 mg qd, 50 mg bid, 100 mg bid and 150 mg bid on Forced Vital Capacity decline during one year, in patients with Idiopathic Pulmonary Fibrosis, with optional active treatment extension until last patient out. - Effect of orally administered BIBF 1120 on FVC decline in IPF | Idiopathic pulmonary fibrosis MedDRA version: 9.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis | Product Name: BIBF 1120 Product Code: BIBF 1120 | Boehringer Ingelheim | NULL | Not Recruiting | Female: yes Male: yes | 400 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | Portugal;Greece;Spain;Ireland;United Kingdom;Italy;France;Hungary;Czech Republic;Belgium;Bulgaria;Germany;Netherlands | ||
| 512 | JPRN-UMIN000010498 | 2007/10/01 | 15/04/2013 | Prognostic Value of Dual-time-point 18F-FDG PET in Fibrotic Idiopathic Interstitial Pneumonia | Prognostic Value of Dual-time-point 18F-FDG PET in Fibrotic Idiopathic Interstitial Pneumonia - Prognostic Value of Dual-time-point 18F-FDG PET in Fibrotic Idiopathic Interstitial Pneumonia | Idiopathic interstital pneumonia | All patients with idiopathic interstitial pneumonia undergo dual-time-point 18F-FDG PET of thorax. | Third Department of Internal Medicine, Faculty of Medical Sciences, University of Fukui | Biomedical Imaging Research Center, Faculty of Medical Sciences, Universtity of Fukui | Complete: follow-up complete | 18years-old | Not applicable | Male and Female | 80 | Not applicable | Japan |
| 513 | EUCTR2006-002875-42-HU (EUCTR) | 26/09/2007 | 27/06/2007 | A 12 month, double blind, randomized, placebo-controlled trial evaluating the effect of BIBF 1120 administered at oral doses of 50 mg qd, 50 mg bid, 100 mg bid and 150 mg bid on Forced Vital Capacity decline during one year, in patients with Idiopathic Pulmonary Fibrosis, with optional active treatment extension until last patient out. - Effect of orally administered BIBF 1120 on FVC decline in IPF | A 12 month, double blind, randomized, placebo-controlled trial evaluating the effect of BIBF 1120 administered at oral doses of 50 mg qd, 50 mg bid, 100 mg bid and 150 mg bid on Forced Vital Capacity decline during one year, in patients with Idiopathic Pulmonary Fibrosis, with optional active treatment extension until last patient out. - Effect of orally administered BIBF 1120 on FVC decline in IPF | Idiopathic pulmonary fibrosis MedDRA version: 9.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis | Product Name: BIBF 1120 Product Code: BIBF 1120 | Boehringer Ingelheim RCV Ges mbH & Co KG | NULL | Not Recruiting | Female: yes Male: yes | 400 | Portugal;Hungary;United Kingdom;Germany;Netherlands;Belgium;Bulgaria;France;Spain;Ireland;Italy;Greece | |||
| 514 | EUCTR2006-002875-42-IE (EUCTR) | 11/09/2007 | 12/06/2007 | A 12 month, double blind, randomized, placebo-controlled trial evaluating the effect of BIBF 1120 administered at oral doses of 50 mg qd, 50 mg bid, 100 mg bid and 150 mg bid on Forced Vital Capacity decline during one year, in patients with Idiopathic Pulmonary Fibrosis, with optional active treatment extension until last patient out. - Effect of orally administered BIBF 1120 on FVC decline in IPF | A 12 month, double blind, randomized, placebo-controlled trial evaluating the effect of BIBF 1120 administered at oral doses of 50 mg qd, 50 mg bid, 100 mg bid and 150 mg bid on Forced Vital Capacity decline during one year, in patients with Idiopathic Pulmonary Fibrosis, with optional active treatment extension until last patient out. - Effect of orally administered BIBF 1120 on FVC decline in IPF | Idiopathic pulmonary fibrosis MedDRA version: 9.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis | Product Name: BIBF 1120 Product Code: BIBF 1120 | Boehringer Ingelheim | NULL | Not Recruiting | Female: yes Male: yes | 400 | Portugal;Hungary;United Kingdom;Germany;Netherlands;Belgium;Bulgaria;France;Spain;Ireland;Italy;Greece | |||
| 515 | EUCTR2007-002324-15-GB (EUCTR) | 04/09/2007 | 17/03/2008 | The efficacy and safety of co-trimoxazole therapy in patients with idiopathic interstitial pneumonia - TIPAC | The efficacy and safety of co-trimoxazole therapy in patients with idiopathic interstitial pneumonia - TIPAC | Idiopathic Interstitial Pneumonia MedDRA version: 9.1;Level: LLT;Classification code 10022619;Term: Interstitial pulmonary fibrosis | Trade Name: Septrin Product Name: co-trimoxazole Product Code: N/A INN or Proposed INN: N/A Other descriptive name: CO-TRIMOXAZOLE | University of East Anglia | NULL | Not Recruiting | Female: yes Male: yes | United Kingdom | ||||
| 516 | NCT00532233 (ClinicalTrials.gov) | September 2007 | 19/9/2007 | SD, IL-13 Production Rate in IPF | A Open-label, Multicenter Study, With a Single Intravenous Dose of QAX576 to Determine IL-13 Production in Patients With Idiopathic Pulmonary Fibrosis | Idiopathic Pulmonary Fibrosis | Drug: QAX576 | Novartis Pharmaceuticals | NULL | Completed | 40 Years | 80 Years | All | 52 | Phase 2 | United States |
| 517 | EUCTR2006-002875-42-FR (EUCTR) | 23/08/2007 | 26/07/2007 | A 12 month, double blind, randomized, placebo-controlled trial evaluating the effect of BIBF 1120 administered at oral doses of 50 mg qd, 50 mg bid, 100 mg bid and 150 mg bid on Forced Vital Capacity decline during one year, in patients with Idiopathic Pulmonary Fibrosis, with optional active treatment extension until last patient out. - Effect of orally administered BIBF 1120 on FVC decline in IPF | A 12 month, double blind, randomized, placebo-controlled trial evaluating the effect of BIBF 1120 administered at oral doses of 50 mg qd, 50 mg bid, 100 mg bid and 150 mg bid on Forced Vital Capacity decline during one year, in patients with Idiopathic Pulmonary Fibrosis, with optional active treatment extension until last patient out. - Effect of orally administered BIBF 1120 on FVC decline in IPF | Idiopathic pulmonary fibrosis MedDRA version: 9.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis | Product Name: BIBF 1120 Product Code: BIBF 1120 | Boehringer Ingelheim France SAS | NULL | Not Recruiting | Female: yes Male: yes | 400 | Phase 2 | Portugal;Greece;Spain;Ireland;Italy;United Kingdom;France;Hungary;Czech Republic;Belgium;Bulgaria;Germany;Netherlands | ||
| 518 | EUCTR2006-002875-42-ES (EUCTR) | 20/08/2007 | 19/06/2007 | Ensayo clínico randomizado, doble ciego, controlado con placebo de 12 meses de duración para evaluar el efecto de BIBF 1120 administrado por vía oral a dosis de 50 mg o.d., 50, 100 y 150 mg b.i.d. sobre la disminución anual de la Capacidad Vital Forzada (CVF) en pacientes con Fibrosis Pulmonar Idiopática, con una fase de extensión opcional hasta el final del ensayo.A 12 month, double blind, randomized, placebo-controlled trial evaluating the effect of BIBF 1120 administered at oral doses of 50 mg qd, 50 mg bid, 100 mg bid and 150 mg bid on Forced Vital Capacity decline during one year, in patients with Idiopathic Pulmonary Fibrosis, with optional active treatment extension until last patient out. | Ensayo clínico randomizado, doble ciego, controlado con placebo de 12 meses de duración para evaluar el efecto de BIBF 1120 administrado por vía oral a dosis de 50 mg o.d., 50, 100 y 150 mg b.i.d. sobre la disminución anual de la Capacidad Vital Forzada (CVF) en pacientes con Fibrosis Pulmonar Idiopática, con una fase de extensión opcional hasta el final del ensayo.A 12 month, double blind, randomized, placebo-controlled trial evaluating the effect of BIBF 1120 administered at oral doses of 50 mg qd, 50 mg bid, 100 mg bid and 150 mg bid on Forced Vital Capacity decline during one year, in patients with Idiopathic Pulmonary Fibrosis, with optional active treatment extension until last patient out. | Fibrosis pulmonar idiopática MedDRA version: 9.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis | Product Name: BIBF 1120 Product Code: BIBF 1120 | Boehringer Ingelheim España, S.A. | NULL | Not Recruiting | Female: yes Male: yes | 400 | Portugal;Hungary;United Kingdom;Germany;Netherlands;Belgium;Bulgaria;France;Ireland;Spain;Italy;Greece | |||
| 519 | EUCTR2006-002875-42-BE (EUCTR) | 14/08/2007 | 24/05/2007 | A 12 month, double blind, randomized, placebo-controlled trial evaluating the effect of BIBF 1120 administered at oral doses of 50 mg qd, 50 mg bid, 100 mg bid and 150 mg bid on Forced Vital Capacity decline during one year, in patients with Idiopathic Pulmonary Fibrosis, with optional active treatment extension until last patient out. - Effect of orally administered BIBF 1120 on FVC decline in IPF | A 12 month, double blind, randomized, placebo-controlled trial evaluating the effect of BIBF 1120 administered at oral doses of 50 mg qd, 50 mg bid, 100 mg bid and 150 mg bid on Forced Vital Capacity decline during one year, in patients with Idiopathic Pulmonary Fibrosis, with optional active treatment extension until last patient out. - Effect of orally administered BIBF 1120 on FVC decline in IPF | Idiopathic pulmonary fibrosis MedDRA version: 9.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis | Product Name: BIBF 1120 Product Code: BIBF 1120 | SCS Boehringer Ingelheim Comm.V | NULL | Not Recruiting | Female: yes Male: yes | 400 | Portugal;Hungary;United Kingdom;Germany;Netherlands;Belgium;Bulgaria;France;Spain;Ireland;Italy;Greece | |||
| 520 | NCT00514683 (ClinicalTrials.gov) | August 2007 | 9/8/2007 | Safety And Efficacy of BIBF 1120 in Idiopathic Pulmonary Fibrosis | A 12 Month, Double Blind, Randomized, Placebo-controlled Trial Evaluating the Effect of BIBF 1120 Administered at Oral Doses of 50 mg qd, 50 mg Bid, 100 mg Bid and 150 mg Bid on Forced Vital Capacity Decline During One Year, in Patients With Idiopathic Pulmonary Fibrosis, With Optional Active Treatment Extension Until Last Patient Out. | Pulmonary Fibrosis | Drug: low dose BIBF1120 once daily;Drug: low dose BIBF 1120 twice daily;Drug: intermediate dose BIBF 1120 twice daily;Drug: high dose BIBF 1120 twice daily;Drug: placebo | Boehringer Ingelheim | NULL | Completed | 40 Years | N/A | All | 432 | Phase 2 | Argentina;Australia;Belgium;Brazil;Bulgaria;Canada;Chile;China;Czech Republic;France;Germany;Greece;Hungary;Ireland;Italy;Korea, Republic of;Mexico;Netherlands;Portugal;Russian Federation;South Africa;Spain;Taiwan;Turkey;United Kingdom;El Salvador |
| 521 | NCT00517933 (ClinicalTrials.gov) | August 2007 | 15/8/2007 | Sildenafil Trial of Exercise Performance in Idiopathic Pulmonary Fibrosis | Sildenafil Trial of Exercise Performance in Idiopathic Pulmonary Fibrosis | Pulmonary Fibrosis;Hypertension, Pulmonary | Drug: Sildenafil Citrate;Other: Placebo | Duke University | National Heart, Lung, and Blood Institute (NHLBI);Pfizer | Completed | 18 Years | N/A | All | 180 | Phase 3 | United States |
| 522 | EUCTR2004-001876-37-DE (EUCTR) | 27/07/2007 | 27/02/2007 | BENEFIT-study: A randomized placebo controlled trial of anti-TNF-alpha chimeric monoclonal antibody ( infliximab) in idiopathic pulmonary fibrosis. - BENEFIT | BENEFIT-study: A randomized placebo controlled trial of anti-TNF-alpha chimeric monoclonal antibody ( infliximab) in idiopathic pulmonary fibrosis. - BENEFIT | Idiopathic Pulmonary Fibrosis MedDRA version: 9.1;Level: LLT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis | Trade Name: Remicade Product Name: Remicade | Academic Medical Centre | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 18 | Germany | |||
| 523 | EUCTR2006-002875-42-IT (EUCTR) | 17/07/2007 | 09/08/2007 | A 12 month, double blind, randomized, placebo-controlled trial evaluating the effect of BIBF 1120 administered at oral doses of 50 mg qd, 50 mg bid, 100 mg bid and 150 mg bid on Forced Vital Capacity decline during one year, in patients with Idiopathic Pulmonary Fibrosis, with optional active treatment extension until last patient out. | A 12 month, double blind, randomized, placebo-controlled trial evaluating the effect of BIBF 1120 administered at oral doses of 50 mg qd, 50 mg bid, 100 mg bid and 150 mg bid on Forced Vital Capacity decline during one year, in patients with Idiopathic Pulmonary Fibrosis, with optional active treatment extension until last patient out. | idiopathic pulmonary fibrosis (IPF) MedDRA version: 14.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: NA Product Code: BIBF 1120 ES | BOEHRINGER ING. | NULL | Not Recruiting | Female: yes Male: yes | 550 | Portugal;France;Hungary;Greece;Spain;Belgium;Ireland;Bulgaria;Netherlands;Germany;United Kingdom;Italy | |||
| 524 | EUCTR2006-002875-42-NL (EUCTR) | 16/07/2007 | 04/06/2007 | A 12 month, double blind, randomized, placebo-controlled trial evaluating the effect of BIBF 1120 administered at oral doses of 50 mg qd, 50 mg bid, 100 mg bid and 150 mg bid on Forced Vital Capacity decline during one year, in patients with Idiopathic Pulmonary Fibrosis, with optional active treatment extension until last patient out. - Effect of orally administered BIBF 1120 on FVC decline in IPF | A 12 month, double blind, randomized, placebo-controlled trial evaluating the effect of BIBF 1120 administered at oral doses of 50 mg qd, 50 mg bid, 100 mg bid and 150 mg bid on Forced Vital Capacity decline during one year, in patients with Idiopathic Pulmonary Fibrosis, with optional active treatment extension until last patient out. - Effect of orally administered BIBF 1120 on FVC decline in IPF | Idiopathic pulmonary fibrosis MedDRA version: 9.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis | Product Name: BIBF 1120 Product Code: BIBF 1120 | Boehringer Ingelheim bv | NULL | Not Recruiting | Female: yes Male: yes | 400 | Portugal;Hungary;United Kingdom;Germany;Netherlands;Belgium;Bulgaria;France;Spain;Ireland;Italy;Greece | |||
| 525 | EUCTR2006-002875-42-DE (EUCTR) | 06/07/2007 | 08/05/2007 | A 12 month, double blind, randomized, placebo-controlled trial evaluating the effect of BIBF 1120 administered at oral doses of 50 mg qd, 50 mg bid, 100 mg bid and 150 mg bid on Forced Vital Capacity decline during one year, in patients with Idiopathic Pulmonary Fibrosis, with optional active treatment extension until last patient out. - Effect of orally administered BIBF 1120 on FVC decline in IPF | A 12 month, double blind, randomized, placebo-controlled trial evaluating the effect of BIBF 1120 administered at oral doses of 50 mg qd, 50 mg bid, 100 mg bid and 150 mg bid on Forced Vital Capacity decline during one year, in patients with Idiopathic Pulmonary Fibrosis, with optional active treatment extension until last patient out. - Effect of orally administered BIBF 1120 on FVC decline in IPF | Idiopathic pulmonary fibrosis MedDRA version: 9.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis | Product Name: BIBF 1120 Product Code: BIBF 1120 | Boehringer Ingelheim | NULL | Not Recruiting | Female: yes Male: yes | 400 | Portugal;France;Hungary;Greece;Spain;Belgium;Ireland;Bulgaria;Netherlands;Germany;United Kingdom;Italy | |||
| 526 | JPRN-UMIN000015929 | 2007/05/10 | 12/12/2014 | Prospective observational study of Idiopathic pulmonary fibrosis with Non-small-cell lung cancer(LOGIK0603) | Prospective observational study of Idiopathic pulmonary fibrosis with Non-small-cell lung cancer(LOGIK0603) - Prospective observational study of Idiopathic pulmonary fibrosis with Non-small-cell lung cancer(LOGIK0603) | Idiopathic pulmonary fibrosis | Carboplatin/paclitaxel combination therapy (dosage and administration) Paclitaxel (PAC):175-200mg/m2 at day1 and carboplatin (CBDCA): AUC 5-6min.mg/mL at day1 are administered and repeated every 21 days as 1 course and the treatment is aimed for more than 3 courses. *The study is discontinued at that point if it becomes PD. | Lung Oncology Group in Kyushu, Japan (LOGIK) | NULL | Complete: follow-up complete | 20years-old | 75years-old | Male and Female | 60 | Not selected | Japan |
| 527 | EUCTR2006-001183-24-IE (EUCTR) | 30/04/2007 | 16/11/2006 | Effects of bosentan on morbidity and mortality in patients with Idiopathic Pulmonary Fibrosis - a multicenter, double-blind, randomized, placebo-controlled, parallel group, event-driven, group sequential, phase III study - BUILD-3 | Effects of bosentan on morbidity and mortality in patients with Idiopathic Pulmonary Fibrosis - a multicenter, double-blind, randomized, placebo-controlled, parallel group, event-driven, group sequential, phase III study - BUILD-3 | Idiopathic Pulmonary Fibrosis (IPF) MedDRA version: 8.1;Level: LLT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis | Trade Name: Tracleer Product Name: Bosentan Product Code: Ro 47-0203 INN or Proposed INN: BOSENTAN Other descriptive name: Tracleer Trade Name: Tracleer Product Name: Bosentan Product Code: Ro 47-0203 INN or Proposed INN: BOSENTAN Other descriptive name: Tracleer | ACTELION PHARMACEUTICALS LTD | NULL | Not Recruiting | Female: yes Male: yes | 390 | Phase 3 | Czech Republic;Germany;United Kingdom;Netherlands;Denmark;Belgium;France;Spain;Ireland;Italy;Austria | ||
| 528 | EUCTR2006-001183-24-GB (EUCTR) | 09/03/2007 | 23/11/2006 | Effects of bosentan on morbidity and mortality in patients with Idiopathic Pulmonary Fibrosis - a multicenter, double-blind, randomized, placebo-controlled, parallel group, event-driven, group sequential, phase III study - BUILD-3 | Effects of bosentan on morbidity and mortality in patients with Idiopathic Pulmonary Fibrosis - a multicenter, double-blind, randomized, placebo-controlled, parallel group, event-driven, group sequential, phase III study - BUILD-3 | Idiopathic Pulmonary Fibrosis (IPF) MedDRA version: 8.1;Level: LLT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis | Trade Name: Tracleer Product Name: Bosentan Product Code: Ro 47-0203 INN or Proposed INN: BOSENTAN Other descriptive name: Tracleer Trade Name: Tracleer Product Name: Bosentan Product Code: Ro 47-0203 INN or Proposed INN: BOSENTAN Other descriptive name: Tracleer | ACTELION PHARMACEUTICALS LTD | NULL | Not Recruiting | Female: yes Male: yes | 600 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | France;Czech Republic;Slovakia;Spain;Belgium;Ireland;Denmark;Austria;Germany;Netherlands;Italy;United Kingdom | ||
| 529 | EUCTR2006-001183-24-NL (EUCTR) | 06/03/2007 | 10/11/2006 | Effects of bosentan on morbidity and mortality in patients with Idiopathic Pulmonary Fibrosis - a multicenter, double-blind, randomized, placebo-controlled, parallel group, event-driven, group sequential, phase III study - BUILD-3 | Effects of bosentan on morbidity and mortality in patients with Idiopathic Pulmonary Fibrosis - a multicenter, double-blind, randomized, placebo-controlled, parallel group, event-driven, group sequential, phase III study - BUILD-3 | Idiopathic Pulmonary Fibrosis (IPF) MedDRA version: 8.1;Level: LLT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis | Trade Name: Tracleer Product Name: Bosentan Product Code: Ro 47-0203 INN or Proposed INN: BOSENTAN Other descriptive name: Tracleer Trade Name: Tracleer Product Name: Bosentan Product Code: Ro 47-0203 INN or Proposed INN: BOSENTAN Other descriptive name: Tracleer | ACTELION PHARMACEUTICALS LTD | NULL | Not Recruiting | Female: yes Male: yes | 600 | Phase 3 | Czech Republic;Germany;United Kingdom;Netherlands;Denmark;Belgium;France;Spain;Ireland;Italy;Austria | ||
| 530 | EUCTR2006-001183-24-SK (EUCTR) | 26/02/2007 | 19/01/2007 | Effects of bosentan on morbidity and mortality in patients with Idiopathic Pulmonary Fibrosis - a multicenter, double-blind, randomized, placebo-controlled, parallel group, event-driven, group sequential, phase III study - BUILD-3 | Effects of bosentan on morbidity and mortality in patients with Idiopathic Pulmonary Fibrosis - a multicenter, double-blind, randomized, placebo-controlled, parallel group, event-driven, group sequential, phase III study - BUILD-3 | Idiopathic Pulmonary Fibrosis (IPF) MedDRA version: 8.1;Level: LLT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis | Trade Name: Tracleer Product Name: Bosentan Product Code: Ro 47-0203 INN or Proposed INN: BOSENTAN Other descriptive name: Tracleer Trade Name: Tracleer Product Name: Bosentan Product Code: Ro 47-0203 INN or Proposed INN: BOSENTAN Other descriptive name: Tracleer | ACTELION PHARMACEUTICALS LTD | NULL | Not Recruiting | Female: yes Male: yes | 390 | Phase 3 | France;Czech Republic;Slovakia;Spain;Belgium;Ireland;Denmark;Austria;Germany;Netherlands;Italy;United Kingdom | ||
| 531 | EUCTR2006-001183-24-DE (EUCTR) | 22/02/2007 | 01/12/2006 | Effects of bosentan on morbidity and mortality in patients with Idiopathic Pulmonary Fibrosis - a multicenter, double-blind, randomized, placebo-controlled, parallel group, event-driven, group sequential, phase III study - BUILD-3 | Effects of bosentan on morbidity and mortality in patients with Idiopathic Pulmonary Fibrosis - a multicenter, double-blind, randomized, placebo-controlled, parallel group, event-driven, group sequential, phase III study - BUILD-3 | Idiopathic Pulmonary Fibrosis (IPF) MedDRA version: 8.1;Level: LLT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis | Trade Name: Tracleer Product Name: Bosentan Product Code: Ro 47-0203 INN or Proposed INN: BOSENTAN Other descriptive name: Tracleer Trade Name: Tracleer Product Name: Bosentan Product Code: Ro 47-0203 INN or Proposed INN: BOSENTAN Other descriptive name: Tracleer | ACTELION PHARMACEUTICALS LTD | NULL | Not Recruiting | Female: yes Male: yes | 600 | Phase 3 | France;Czech Republic;Spain;Belgium;Ireland;Denmark;Austria;Netherlands;Germany;Italy;United Kingdom | ||
| 532 | EUCTR2006-001183-24-ES (EUCTR) | 14/02/2007 | 07/04/2010 | Efectos de Bosentan sobre la morbilidad y mortalidad en pacientes con Fibrosis Pulmonar Idiopática- Estudio fase III, multicéntrico, randomizado, de grupos paralelos, doble ciego, controlado con placebo, secuencial por grupos, condicionado por acontecimientos.English:Effects of bosentan on morbidity and mortality in patients with Idiopathic Pulmonary Fibrosis - a multicenter, double-blind, randomized, placebo-controlled, parallel group, event-driven, group sequential, phase III study - BUILD-3 | Efectos de Bosentan sobre la morbilidad y mortalidad en pacientes con Fibrosis Pulmonar Idiopática- Estudio fase III, multicéntrico, randomizado, de grupos paralelos, doble ciego, controlado con placebo, secuencial por grupos, condicionado por acontecimientos.English:Effects of bosentan on morbidity and mortality in patients with Idiopathic Pulmonary Fibrosis - a multicenter, double-blind, randomized, placebo-controlled, parallel group, event-driven, group sequential, phase III study - BUILD-3 | Spanish:Fibrosis Pulmonar IdiopáticaEnglish:Idiopathic Pulmonary Fibrosis MedDRA version: 8.1;Level: LLT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis | Trade Name: Tracleer Product Name: Bosentan Product Code: Ro 47-0203 INN or Proposed INN: BOSENTAN Other descriptive name: Tracleer Trade Name: Tracleer Product Name: Bosentan Product Code: Ro 47-0203 INN or Proposed INN: BOSENTAN Other descriptive name: Tracleer | ACTELION PHARMACEUTICALS LTD | NULL | Not Recruiting | Female: yes Male: yes | 600 | Phase 3 | France;Czech Republic;Slovakia;Belgium;Spain;Ireland;Denmark;Austria;Germany;Netherlands;Italy;United Kingdom | ||
| 533 | EUCTR2006-001183-24-CZ (EUCTR) | 07/02/2007 | 21/12/2006 | Effects of bosentan on morbidity and mortality in patients with Idiopathic Pulmonary Fibrosis - a multicenter, double-blind, randomized, placebo-controlled, parallel group, event-driven, group sequential, phase III study - BUILD-3 | Effects of bosentan on morbidity and mortality in patients with Idiopathic Pulmonary Fibrosis - a multicenter, double-blind, randomized, placebo-controlled, parallel group, event-driven, group sequential, phase III study - BUILD-3 | Idiopathic Pulmonary Fibrosis (IPF) MedDRA version: 8.1;Level: LLT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis | Trade Name: Tracleer Product Name: Bosentan Product Code: Ro 47-0203 INN or Proposed INN: BOSENTAN Other descriptive name: Tracleer Trade Name: Tracleer Product Name: Bosentan Product Code: Ro 47-0203 INN or Proposed INN: BOSENTAN Other descriptive name: Tracleer | ACTELION PHARMACEUTICALS LTD | NULL | Not Recruiting | Female: yes Male: yes | 600 | Phase 3 | Germany;United Kingdom;Czech Republic;Netherlands;Denmark;Belgium;France;Spain;Ireland;Italy;Austria | ||
| 534 | NCT00625079 (ClinicalTrials.gov) | February 2007 | 19/2/2008 | Pulmonary Hypertension Secondary to Idiopathic Pulmonary Fibrosis And Treatment With Sildenafil | Randomized Placebo-Controlled Study of Sildenafil For The Treatment of Pulmonary Hypertension Secondary to Idiopathic Pulmonary Fibrosis: A Pilot Study | Pulmonary Arterial Hypertension;Idiopathic Pulmonary Fibrosis;Interstitial Lung Disease;Pulmonary Hypertension | Drug: sildenafil | University of California, Los Angeles | Pfizer | Withdrawn | N/A | N/A | All | 0 | Phase 4 | United States |
| 535 | NCT00391443 (ClinicalTrials.gov) | February 2007 | 20/10/2006 | BUILD 3: Bosentan Use in Interstitial Lung Disease | Effects of Bosentan on Morbidity and Mortality in Patients With Idiopathic Pulmonary Fibrosis - a Multicenter, Double-blind, Randomized, Placebo-controlled, Parallel Group, Event-driven, Group Sequential, Phase III Study. | Idiopathic Pulmonary Fibrosis | Drug: Bosentan;Drug: Placebo | Actelion | NULL | Completed | 18 Years | N/A | All | 616 | Phase 3 | United States;Australia;Austria;Belgium;Canada;Croatia;Czech Republic;France;Germany;Ireland;Israel;Italy;Japan;Korea, Republic of;Netherlands;Serbia;Spain;Switzerland;United Kingdom;Denmark;Former Serbia and Montenegro;Slovakia |
| 536 | EUCTR2006-001183-24-DK (EUCTR) | 24/01/2007 | 12/12/2006 | Effects of bosentan on morbidity and mortality in patients with Idiopathic Pulmonary Fibrosis - a multicenter, double-blind, randomized, placebo-controlled, parallel group, event-driven, group sequential, phase III study - BUILD-3 | Effects of bosentan on morbidity and mortality in patients with Idiopathic Pulmonary Fibrosis - a multicenter, double-blind, randomized, placebo-controlled, parallel group, event-driven, group sequential, phase III study - BUILD-3 | Idiopathic Pulmonary Fibrosis (IPF) MedDRA version: 8.1;Level: LLT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis | Trade Name: Tracleer Product Name: Bosentan Product Code: Ro 47-0203 INN or Proposed INN: BOSENTAN Other descriptive name: Tracleer Trade Name: Tracleer Product Name: Bosentan Product Code: Ro 47-0203 INN or Proposed INN: BOSENTAN Other descriptive name: Tracleer | ACTELION PHARMACEUTICALS LTD | NULL | Not Recruiting | Female: yes Male: yes | 390 | Phase 3 | Czech Republic;Germany;United Kingdom;Netherlands;Belgium;Denmark;France;Spain;Ireland;Italy;Austria | ||
| 537 | EUCTR2006-001183-24-AT (EUCTR) | 10/01/2007 | 11/12/2006 | Effects of bosentan on morbidity and mortality in patients with Idiopathic Pulmonary Fibrosis - a multicenter, double-blind, randomized, placebo-controlled, parallel group, event-driven, group sequential, phase III study - BUILD-3 | Effects of bosentan on morbidity and mortality in patients with Idiopathic Pulmonary Fibrosis - a multicenter, double-blind, randomized, placebo-controlled, parallel group, event-driven, group sequential, phase III study - BUILD-3 | Idiopathic Pulmonary Fibrosis (IPF) MedDRA version: 8.1;Level: LLT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis | Trade Name: Tracleer Product Name: Bosentan Product Code: Ro 47-0203 INN or Proposed INN: BOSENTAN Other descriptive name: Tracleer Trade Name: Tracleer Product Name: Bosentan Product Code: Ro 47-0203 INN or Proposed INN: BOSENTAN Other descriptive name: Tracleer | ACTELION PHARMACEUTICALS LTD | NULL | Not Recruiting | Female: yes Male: yes | 600 | Phase 3 | Czech Republic;Germany;United Kingdom;Netherlands;Denmark;Belgium;France;Spain;Ireland;Italy;Austria | ||
| 538 | NCT00563212 (ClinicalTrials.gov) | January 2007 | 21/11/2007 | A Pilot Study of Aerosol Interferon-gamma for Treatment of Idiopathic Pulmonary Fibrosis | A Pilot Study of Aerosol Interferon-gamma for Treatment of Idiopathic Pulmonary Fibrosis | Pulmonary Fibrosis | Drug: aerosol interferon-gamma | NYU Langone Health | National Center for Research Resources (NCRR);Stony Brook University;Philips Respironics | Completed | 40 Years | 75 Years | All | 12 | Phase 1 | United States |
| 539 | EUCTR2006-001183-24-BE (EUCTR) | 12/12/2006 | 14/11/2006 | Effects of bosentan on morbidity and mortality in patients with Idiopathic Pulmonary Fibrosis - a multicenter, double-blind, randomized, placebo-controlled, parallel group, event-driven, group sequential, phase III study - BUILD-3 | Effects of bosentan on morbidity and mortality in patients with Idiopathic Pulmonary Fibrosis - a multicenter, double-blind, randomized, placebo-controlled, parallel group, event-driven, group sequential, phase III study - BUILD-3 | Idiopathic Pulmonary Fibrosis (IPF) MedDRA version: 8.1;Level: LLT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis | Trade Name: Tracleer Product Name: Bosentan Product Code: Ro 47-0203 INN or Proposed INN: BOSENTAN Other descriptive name: Tracleer Trade Name: Tracleer Product Name: Bosentan Product Code: Ro 47-0203 INN or Proposed INN: BOSENTAN Other descriptive name: Tracleer | ACTELION PHARMACEUTICALS LTD | NULL | Not Recruiting | Female: yes Male: yes | 460 | Phase 3 | Czech Republic;Germany;United Kingdom;Netherlands;Denmark;Belgium;France;Spain;Ireland;Italy;Austria | ||
| 540 | EUCTR2006-001183-24-IT (EUCTR) | 11/12/2006 | 05/01/2007 | Effects of bosentan on morbidity and mortality in patients with Idiopathic Pulmonary Fibrosis - a multicenter, double-blind, randomized, placebo-controlled, parallel group, event-driven, group sequential, phase III study - BUILD 3 | Effects of bosentan on morbidity and mortality in patients with Idiopathic Pulmonary Fibrosis - a multicenter, double-blind, randomized, placebo-controlled, parallel group, event-driven, group sequential, phase III study - BUILD 3 | Patients with Idiopathic pulmonary fibrosis Level: PTClassification code 10037383 | Trade Name: TRACLEER | Actelion Pharmaceuticals LTD | NULL | Not Recruiting | Female: yes Male: yes | 390 | Phase 3 | Czech Republic;Germany;United Kingdom;Netherlands;Denmark;Belgium;France;Spain;Ireland;Italy;Austria | ||
| 541 | EUCTR2006-002174-22-DE (EUCTR) | 08/11/2006 | 23/08/2006 | Influence of inhaled Aviptadil on CCL18 serum concentrations in patients with pulmonary fibrosis - Inhaled Aviptadil in pulmonary fibrosis | Influence of inhaled Aviptadil on CCL18 serum concentrations in patients with pulmonary fibrosis - Inhaled Aviptadil in pulmonary fibrosis | Pulmonary Fibrosis categorized as UIP or NSIP | Product Name: Aviptadil, 66 microgram/mL Other descriptive name: Vasoactive intestinal peptide | Mondobiotech Laboratories Anstalt | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | Germany | ||||
| 542 | NCT00463983 (ClinicalTrials.gov) | October 2006 | 18/4/2007 | Treatment of Idiopathic Pulmonary Fibrosis With Long Acting Octreotide | Phase 2 Study of Long Acting Octreotide in Idiopathic Pulmonary Fibrosis | Idiopathic Pulmonary Fibrosis | Drug: octreotide | Institut National de la Santé Et de la Recherche Médicale, France | NULL | Completed | 40 Years | N/A | Both | 25 | Phase 1/Phase 2 | France |
| 543 | EUCTR2006-000252-41-IT (EUCTR) | 27/09/2006 | 30/08/2006 | A randomized, Double-Blind, Placebo-Controlled, Phase 3, Three-Arm Study of the Safety and Efficacy of Pirferidone in patients with Idiopathic Pulmonary Fibrosis - ND | A randomized, Double-Blind, Placebo-Controlled, Phase 3, Three-Arm Study of the Safety and Efficacy of Pirferidone in patients with Idiopathic Pulmonary Fibrosis - ND | Idiopathic pulmonary fibrosis IPF ICD X J84.1other interstitial pulmonary MedDRA version: 6.1;Level: PT;Classification code 10037383 | Product Name: PIR, S-7701 | INTERMUNE | NULL | Not Recruiting | Female: yes Male: yes | 325 | Phase 3 | United Kingdom;Italy | ||
| 544 | EUCTR2006-000138-11-ES (EUCTR) | 31/07/2006 | 18/05/2006 | A Randomised, Double-Blind, Placebo-Controlled, Phase 3 Study of the Safety and Efficacy of Pirfenidone in Patients with Idiopathic Pulmonary FibrosisEstudio aleatorio, a doble ciego, controlado con placebo, de fase 3 sobre la seguridad y eficacia de Pirfenidona en pacientes con fibrosis pulmonar idiopática | A Randomised, Double-Blind, Placebo-Controlled, Phase 3 Study of the Safety and Efficacy of Pirfenidone in Patients with Idiopathic Pulmonary FibrosisEstudio aleatorio, a doble ciego, controlado con placebo, de fase 3 sobre la seguridad y eficacia de Pirfenidona en pacientes con fibrosis pulmonar idiopática | Idiopathic Pulmonary Fibrosis (IPF)Fibrosis Pulmonar Idiopática | Product Name: Pirfenidone INN or Proposed INN: Pirfenidone | InterMune, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 260 | Phase 3 | Czech Republic;Belgium;Spain;Ireland;Germany | ||
| 545 | NCT00287716 (ClinicalTrials.gov) | July 14, 2006 | 6/2/2006 | Three-Arm Study of the Safety and Efficacy of Pirfenidone in Patients With Idiopathic Pulmonary Fibrosis | A Randomized, Double-Blind, Placebo Controlled, Phase 3, Three-Arm Study of the Safety and Efficacy of Pirfenidone in Patients With Idiopathic Pulmonary Fibrosis | Idiopathic Pulmonary Fibrosis | Drug: Pirfenidone;Drug: Placebo | Genentech, Inc. | NULL | Completed | 40 Years | 80 Years | All | 435 | Phase 3 | United States |
| 546 | NCT00359736 (ClinicalTrials.gov) | July 2006 | 31/7/2006 | Sildenafil Study to Treat Idiopathic Pulmonary Fibrosis | Vasodilator Therapy and Exercise Tolerance in IPF Patients | Alveolitis, Fibrosing;Fibrosis, Pulmonary;Hypertension, Pulmonary | Drug: sildenafil | VA Office of Research and Development | NULL | Completed | 40 Years | 85 Years | All | 29 | Phase 2 | United States |
| 547 | EUCTR2006-000138-11-DE (EUCTR) | 29/06/2006 | 16/02/2006 | A Randomised, Double-Blind, Placebo-Controlled, Phase 3 Study of the Safety and Efficacy of Pirfenidone in Patients with Idiopathic Pulmonary Fibrosis | A Randomised, Double-Blind, Placebo-Controlled, Phase 3 Study of the Safety and Efficacy of Pirfenidone in Patients with Idiopathic Pulmonary Fibrosis | Idiopathic Pulmonary Fibrosis (IPF) MedDRA version: 9.1;Level: LLT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis | Product Name: Pirfenidone INN or Proposed INN: Pirfenidone | InterMune, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 260 | Phase 3 | Czech Republic;Germany;Belgium;Spain;Ireland | ||
| 548 | EUCTR2006-000252-41-GB (EUCTR) | 29/06/2006 | 11/04/2006 | A Randomized, Double-Blind, Placebo Controlled, Phase 3 Three-Arm Study of the Safety and Efficacy of Pirfenidone in Patients with Idiopathic Pulmonary Fibrosis | A Randomized, Double-Blind, Placebo Controlled, Phase 3 Three-Arm Study of the Safety and Efficacy of Pirfenidone in Patients with Idiopathic Pulmonary Fibrosis | Idiopathic Pulmonary Fibrosis (IPF) MedDRA version: 9.1;Level: LLT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis | Product Name: Pirfenidone INN or Proposed INN: Pirfenidone Product Name: Pirfenidone INN or Proposed INN: Pirfenidone | InterMune, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 325 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Italy;United Kingdom | ||
| 549 | EUCTR2006-000138-11-BE (EUCTR) | 27/06/2006 | 10/03/2006 | A Randomised, Double-Blind, Placebo-Controlled, Phase 3 Study of the Safety and Efficacy of Pirfenidone in Patients with Idiopathic Pulmonary Fibrosis | A Randomised, Double-Blind, Placebo-Controlled, Phase 3 Study of the Safety and Efficacy of Pirfenidone in Patients with Idiopathic Pulmonary Fibrosis | Idiopathic Pulmonary Fibrosis (IPF) MedDRA version: 9.1;Level: LLT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis | Product Name: Pirfenidone INN or Proposed INN: Pirfenidone | InterMune, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 260 | Phase 3 | Czech Republic;Germany;Belgium;Spain;Ireland | ||
| 550 | EUCTR2006-000138-11-CZ (EUCTR) | 25/05/2006 | 06/04/2006 | A Randomised, Double-Blind, Placebo-Controlled, Phase 3 Study of the Safety and Efficacy of Pirfenidone in Patients with Idiopathic Pulmonary Fibrosis | A Randomised, Double-Blind, Placebo-Controlled, Phase 3 Study of the Safety and Efficacy of Pirfenidone in Patients with Idiopathic Pulmonary Fibrosis | Idiopathic Pulmonary Fibrosis (IPF) | Product Name: Pirfenidone INN or Proposed INN: Pirfenidone | InterMune, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 260 | Phase 3 | Germany;Czech Republic;Belgium;Spain;Ireland | ||
| 551 | NCT00287729 (ClinicalTrials.gov) | April 2006 | 6/2/2006 | Safety and Efficacy of Pirfenidone in Patients With Idiopathic Pulmonary Fibrosis | A Randomized, Double-Blind, Placebo Controlled, Phase 3 Study of the Safety and Efficacy of Pirfenidone in Patients With Idiopathic Pulmonary Fibrosis | Idiopathic Pulmonary Fibrosis | Drug: Pirfenidone;Drug: Placebo | Genentech, Inc. | NULL | Completed | 40 Years | 80 Years | All | 344 | Phase 3 | United States |
| 552 | NCT00125385 (ClinicalTrials.gov) | July 2005 | 29/7/2005 | Study of GC1008 in Patients With Idiopathic Pulmonary Fibrosis (IPF) | Phase I, Open-Label, Multi-Center, Single-Dose, Dose-Escalating, Safety, Tolerability and Pharmacokinetic of GC1008 in Patients With Idiopathic Pulmonary Fibrosis | Idiopathic Pulmonary Fibrosis | Biological: GC1008 | Genzyme, a Sanofi Company | NULL | Completed | 18 Years | 79 Years | Both | 25 | Phase 1 | United States;Belgium |
| 553 | NCT00518310 (ClinicalTrials.gov) | May 2005 | 16/8/2007 | Azathioprine and Prednisone in the Treatment of Idiopathic Pulmonary Fibrosis | Azathioprine and Prednisone in the Treatment of Idiopathic Pulmonary Fibrosis: a Randomized, Double-Blind, Controlled Study | Idiopathic Pulmonary Fibrosis | Drug: Placebo;Drug: AZAPRED | Thorax National Institute | Sociedad Chilena de Enfermedades Respiratorias;Servicio de Salud Metropolitano Oriente, Ministerio de Salud de Chile | Recruiting | 45 Years | 79 Years | Both | 100 | N/A | Chile |
| 554 | NCT00109681 (ClinicalTrials.gov) | April 2005 | 2/5/2005 | Inhaled Iloprost in Adults With Abnormal Pulmonary Pressure and Associated With Idiopathic Pulmonary Fibrosis | A Randomized, Double-blind, Placebo-Controlled Phase II Study to Evaluate the Safety and Pilot Efficacy of Iloprost Inhalation Solution in Adults With Abnormal Pulmonary Arterial Pressure and Exercise Limitation Associated With Idiopathic Pulmonary Fibrosis (IPF) | Pulmonary Fibrosis;Pulmonary Hypertension | Drug: Iloprost Inhalation Solution (Ventavis) | Actelion | NULL | Completed | 40 Years | 85 Years | Both | 50 | Phase 2 | United States |
| 555 | EUCTR2004-000029-31-IE (EUCTR) | 28/01/2005 | 08/12/2004 | A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study of the Safety and Efficacy of Interferon gamma-Ib in patients with Idiopathic Pulmonary Fibrosis The INSPIRE Trial - International Study of Survival outcomes in IPF with Interferon gamma-1b) - INSPIRE | A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study of the Safety and Efficacy of Interferon gamma-Ib in patients with Idiopathic Pulmonary Fibrosis The INSPIRE Trial - International Study of Survival outcomes in IPF with Interferon gamma-1b) - INSPIRE | Idiopathic Pulmonary Fibrosis (IPF) | Trade Name: Immukin Product Name: Interferon gamma-1b | InterMune | NULL | Not Recruiting | Female: yes Male: yes | 600 | Phase 3 | Ireland | ||
| 556 | NCT00105183 (ClinicalTrials.gov) | January 2005 | 8/3/2005 | EZ-2053 in the Prophylaxis of Acute Pulmonary Allograft Rejection | A Double-Blind, Placebo-Controlled, Multicenter, Dose-Ranging Study of an Anti-human-T-lymphocyte Immune Globulin (EZ-2053) in the Prophylaxis of Acute Pulmonary Allograft Rejection in Adult Recipients of Primary Pulmonary Allograft(s) | Chronic Obstructive Pulmonary;Idiopathic Pulmonary Fibrosis;Cystic Fibrosis;Bronchiectasis;Pulmonary Vascular Disease | Biological: Placebo;Biological: EZ-2053;Biological: EZ-2053 5mg/kg | Neovii Biotech | NULL | Completed | 18 Years | N/A | All | 223 | Phase 3 | United States;Australia;Austria;Canada |
| 557 | NCT00352482 (ClinicalTrials.gov) | November 2004 | 13/7/2006 | Sildenafil to Increase Exercise Capacity in Individuals With Idiopathic Pulmonary Fibrosis and Pulmonary Hypertension | Sildenafil Treatment in Patients With Idiopathic Pulmonary Fibrosis and Pulmonary Hypertension - a Pilot Cross-over Study | Pulmonary Fibrosis;Hypertension, Pulmonary | Drug: Sildenafil (50 mg) | National Heart, Lung, and Blood Institute (NHLBI) | NULL | Completed | 19 Years | N/A | Both | 20 | Phase 2 | United States |
| 558 | NCT00075998 (ClinicalTrials.gov) | December 2003 | 12/1/2004 | The INSPIRE Trial: A Study of Interferon Gamma-1b for Idiopathic Pulmonary Fibrosis (IPF) | A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study of the Safety and Efficacy of Interferon Gamma-1b in Patients With Idiopathic Pulmonary Fibrosis (The INSPIRE Trial) | Idiopathic Pulmonary Fibrosis;Lung Disease;Pulmonary Fibrosis | Drug: Interferon gamma-1b (Actimmune) | InterMune | NULL | Terminated | 40 Years | 79 Years | Both | 826 | Phase 3 | United States |
| 559 | NCT00162760 (ClinicalTrials.gov) | October 2003 | 8/9/2005 | Treatment of Idiopathic Pulmonary Fibrosis With Thalidomide | Treatment of Idiopathic Pulmonary Fibrosis With Thalidomide | Idiopathic Pulmonary Fibrosis (IPF) | Drug: Thalidomide | Johns Hopkins University | Celgene Corporation | Completed | 50 Years | 80 Years | Both | 19 | Phase 2 | United States |
| 560 | NCT00080223 (ClinicalTrials.gov) | August 31, 2003 | 24/3/2004 | Safety Study of Oral Pirfenidone in Patients With Pulmonary Fibrosis/Idiopathic Pulmonary Fibrosis | An Open-Label, Phase 2 Study of the Safety of Oral Pirfenidone in Patients With Pulmonary Fibrosis/Idiopathic Pulmonary Fibrosis | Idiopathic Pulmonary Fibrosis;Pulmonary Fibrosis | Drug: Pirfenidone | Genentech, Inc. | NULL | Completed | 40 Years | 85 Years | All | 83 | Phase 2 | United States |
| 561 | NCT00071461 (ClinicalTrials.gov) | August 2003 | 23/10/2003 | Efficacy and Safety of Oral Bosentan in Patients With Idiopathic Pulmonary Fibrosis | A Double-blind, Randomized, Placebo-controlled, Multicenter Study to Assess the Efficacy, Safety, and Tolerability of Bosentan in Patients With Idiopathic Pulmonary Fibrosis, Open Label Extension | Idiopathic Pulmonary Fibrosis | Drug: bosentan;Drug: Placebo | Actelion | NULL | Completed | 18 Years | N/A | Both | 158 | Phase 2/Phase 3 | United States;Canada;France;Germany;Israel;Italy;Switzerland;United Kingdom |
| 562 | NCT00063869 (ClinicalTrials.gov) | July 2003 | 7/7/2003 | Study Evaluating the Safety and Efficacy of Etanercept in Patients With Idiopathic Pulmonary Fibrosis | A Double-blind, Parallel, Placebo-controlled, Randomized Study of the Efficacy and Safety of Etanercept in Patients With Idiopathic Pulmonary Fibrosis. | Pulmonary Fibrosis | Drug: Etanercept | Wyeth is now a wholly owned subsidiary of Pfizer | NULL | Completed | 40 Years | 80 Years | Both | 88 | Phase 2 | United States |
| 563 | NCT00131274 (ClinicalTrials.gov) | April 2003 | 17/8/2005 | Gleevec Idiopathic Pulmonary Fibrosis (IPF) Study | A Double-Blind, Placebo-Controlled, Randomized Study of the Efficacy (Gleevec Imatinib Mesylate) in Patients With Idiopathic Pulmonary Fibrosis | Idiopathic Pulmonary Fibrosis;Lung Disease;Pulmonary Fibrosis | Drug: Imatinib Mesylate (Gleevec) | Daniels, Craig E., M.D. | Novartis | Completed | 20 Years | 79 Years | Both | 120 | Phase 2/Phase 3 | NULL |
| 564 | NCT00189176 (ClinicalTrials.gov) | March 2003 | 10/9/2005 | Safety Study of Tetrathiomolybdate in Patients With Idiopathic Pulmonary Fibrosis | Phase I/II Trial of Tetrathiomolybdate (TM) in Patients With Usual Interstitial Pneumonia Refractory to Previous Therapy | Idiopathic Pulmonary Fibrosis | Drug: Tetrathiomolybdate | University of Michigan | Coalition for Pulmonary Fibrosis | Completed | 35 Years | 80 Years | Both | 23 | Phase 1/Phase 2 | United States |
| 565 | NCT00052052 (ClinicalTrials.gov) | September 2002 | 21/1/2003 | An Open-Label Study of the Safety and Efficacy of Subcutaneous Recombinant Interferon-Gamma 1b (IFN-Gamma 1b) in Patients With Idiopathic Pulmonary Fibrosis (IPF) | An Open-Label Study of the Safety and Efficacy of Subcutaneous Recombinant Interferon Gamma-1b in Patients With Idiopathic Pulmonary Fibrosis. | Lung Disease;Pulmonary Fibrosis | Drug: interferon-gamma 1b | InterMune | NULL | Completed | 20 Years | 79 Years | Both | 210 | Phase 2 | United States |
| 566 | NCT00052039 (ClinicalTrials.gov) | April 2002 | 21/1/2003 | A Randomized, Double-Blind, Three-Arm, Phase 3b Study Comparing the Safety and Efficacy of Interferon Gamma-1b With Azathioprine, and Azathioprine Alone in Patients With IPF Receiving Prednisone | A Randomized, Double-Blind, Three-Arm, Phase IIIb Study Comparing the Safety and Efficacy of Interferon Gamma-1b Alone, IFN-Gamma 1b With Azathioprine, and Azathioprine Alone in Patients With Idiopathic Pulmonary Fibrosis Receiving Prednisone | Lung Disease;Pulmonary Fibrosis | Drug: interferon-gamma 1b;Drug: azathioprine | InterMune | NULL | Terminated | 20 Years | 79 Years | Both | 0 | Phase 3 | Italy |
| 567 | NCT00047658 (ClinicalTrials.gov) | November 2001 | 9/10/2002 | A Study of the Safety and Clinical Effects of Interferon Gamma-1b in Patients With Idiopathic Pulmonary Fibrosis (IPF) | A Phase II, Randomized, Double-Blind, Placebo-Controlled Study of the Safety, Biology, and Clinical Effects of Interferon Gamma-1b Administered Subcutaneously to Patients With IPF Followed by an Open-Label Extension | Idiopathic Pulmonary Fibrosis | Drug: Interferon-gamma 1b | InterMune | NULL | Completed | 20 Years | 79 Years | Both | 32 | Phase 2 | United States |
| 568 | NCT00262405 (ClinicalTrials.gov) | January 2001 | 12/9/2005 | Zileuton for the Treatment of Idiopathic Pulmonary Fibrosis | Phase II Trial of Zileuton Compared to Azathioprine/Prednisone for the Treatment of Idiopathic Pulmonary Fibrosis | Idiopathic Pulmonary Fibrosis | Drug: zileuton;Drug: azathioprine/prednisone | University of Michigan | National Institutes of Health (NIH) | Completed | 35 Years | 80 Years | Both | 44 | Phase 2 | United States |
| 569 | NCT01442779 (ClinicalTrials.gov) | September 2000 | 23/9/2009 | Clinical Trial of Low Dose Oral Interferon Alpha in Idiopathic Pulmonary Fibrosis | Clinical Trial of Low Dose Oral Interferon Alpha in Idiopathic Pulmonary Fibrosis | Respiratory Tract Diseases;Lung Diseases;Lung Diseases, Interstitial;Pulmonary Fibrosis | Drug: Interferon alpha oral lozenge | Texas Tech University Health Sciences Center | Amarillo Biosciences, Inc. | Completed | 50 Years | N/A | All | 18 | Phase 2 | United States |
| 570 | NCT00047645 (ClinicalTrials.gov) | April 2000 | 9/10/2002 | A Study of the Safety and Efficacy Interferon-Gamma 1b in Patients With Idiopathic Pulmonary Fibrosis (IPF) | A Randomized, Double-Blind, Placebo-Controlled, Phase III Study of the Safety and Efficacy of Subcutaneous Recombinant Interferon-Gamma 1b in Patients With Idiopathic Pulmonary Fibrosis | Idiopathic Pulmonary Fibrosis | Drug: Interferon-gamma 1b | InterMune | NULL | Completed | 20 Years | 79 Years | Both | 330 | Phase 3 | United States |
| 571 | NCT00639496 (ClinicalTrials.gov) | March 2000 | 13/3/2008 | Study of the Effects of High-dose N-acetylcysteine (NAC) in Idiopathic Pulmonary Fibrosis (IPF) | Idiopathic Pulmonary Fibrosis International Group Exploring NAC I Annual Study of the Effects of High-dose N-acetylcysteine (NAC) in Idiopathic Pulmonary Fibrosis (IPF) | Pulmonary Fibrosis | Drug: n-acetylcysteine;Drug: placebo | Zambon SpA | NULL | Completed | 18 Years | 75 Years | Both | 184 | Phase 3 | Belgium;France;Germany;Italy;Netherlands;Spain;United Kingdom |
| 572 | NCT00074698 (ClinicalTrials.gov) | September 1994 | 18/12/2003 | Safety and Tolerability Study of FG-3019 in Patients With Idiopathic Pulmonary Fibrosis | A Phase 1 Study of the Safety, Pharmacokinetics, and Biologic Activity of Escalating Doses of FG-3019 in Subjects With Idiopathic Pulmonary Fibrosis | Idiopathic Pulmonary Fibrosis | Drug: FG-3019 | FibroGen | NULL | Completed | 21 Years | 80 Years | Both | 27 | Phase 1 | United States |
| 573 | JPRN-JapicCTI-142452 | 21/02/2014 | A Phase 2, Multicenter, Double-Blind Within Cohort, Dose-escalation Study to Evaluate the Safety and Tolerability of Multiple Doses of CAT-354 (Tralokinumab) in Japanese Patients With Idiopathic Pulmonary Fibrosis | A Phase 2, Multicenter, Double-Blind Within Cohort, Dose-escalation Study to Evaluate the Safety and Tolerability of Multiple Doses of CAT-354 (Tralokinumab) in Japanese Patients With Idiopathic Pulmonary Fibrosis | Idiopathic Pulmonary Fibrosis | Intervention name : Tralokinumab is a human recombinant monoclonal antibody (MAb) of the subclass that specifically binds human IL-13, blocking interactions with the IL-13 receptor Dosage And administration of the intervention : Low Dose, Biological: tralokinumab cohort 1, High Dose, Biological: tralokinumab cohort 2 | AstraZeneca | MedImmune LLC | 50 | BOTH | Phase 2 | NULL | ||||
| 574 | EUCTR2006-001183-24-FR (EUCTR) | 28/11/2006 | Effects of bosentan on morbidity and mortality in patients with Idiopathic Pulmonary Fibrosis - a multicenter, double-blind, randomized, placebo-controlled, parallel group, event-driven, group sequential, phase III study - BUILD-3 | Effects of bosentan on morbidity and mortality in patients with Idiopathic Pulmonary Fibrosis - a multicenter, double-blind, randomized, placebo-controlled, parallel group, event-driven, group sequential, phase III study - BUILD-3 | Idiopathic Pulmonary Fibrosis (IPF) MedDRA version: 8.1;Level: LLT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis | Trade Name: Tracleer INN or Proposed INN: BOSENTAN Other descriptive name: Tracleer Trade Name: Tracleer INN or Proposed INN: BOSENTAN Other descriptive name: Tracleer | ACTELION PHARMACEUTICALS LTD | NULL | Not Recruiting | Female: yes Male: yes | 390 | Phase 3 | France;Czech Republic;Slovakia;Spain;Belgium;Ireland;Denmark;Austria;Germany;Netherlands;Italy;United Kingdom | |||
| 575 | EUCTR2008-006054-17-DE (EUCTR) | 05/03/2009 | A double-blind, randomized, placebo-controlled, multicenter, parallel group study to evaluate the efficacy, safety, and tolerability of macitentan in patients with idiopathic pulmonary fibrosis - MUSIC | A double-blind, randomized, placebo-controlled, multicenter, parallel group study to evaluate the efficacy, safety, and tolerability of macitentan in patients with idiopathic pulmonary fibrosis - MUSIC | To evaluate the efficacy, safety, and tolerabilitiy of macitentan in patients with idiopathic pulmonary fibrosis. MedDRA version: 9.1;Level: LLT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis | Product Name: macitentan Product Code: ACT-064992 INN or Proposed INN: macitentan | Actelion Pharmaceuticals Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 156 | France;Slovenia;Spain;Germany;Italy;Sweden | ||||
| 576 | EUCTR2008-004405-34-DE (EUCTR) | 14/01/2009 | A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multi-Center, Parallel-Group, Event-Driven Study to Evaluate the Efficacy and Safety of Ambrisentan in Subjects with Early Idiopathic Pulmonary Fibrosis (IPF) - ARTEMIS-IPF | A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multi-Center, Parallel-Group, Event-Driven Study to Evaluate the Efficacy and Safety of Ambrisentan in Subjects with Early Idiopathic Pulmonary Fibrosis (IPF) - ARTEMIS-IPF | Idiopathic pulmonary fibrosis (IPF) MedDRA version: 9.1;Level: LLT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis | Trade Name: Letairis 5 mg INN or Proposed INN: Ambrisentan Trade Name: Letairis 10 mg INN or Proposed INN: Ambrisentan | Gilead Sciences Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 660 | Phase 3 | France;Czech Republic;Spain;Belgium;Ireland;Austria;Netherlands;Germany;Italy;United Kingdom |