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 | 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 |
| 2 | 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 | ||
| 3 | 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 |
| 4 | 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 |
| 5 | 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 |
| 6 | 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 |
| 7 | 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 |
| 8 | 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 | ||
| 9 | 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 | ||
| 10 | 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 | ||
| 11 | 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 |
| 12 | NCT03939520 (ClinicalTrials.gov) | June 11, 2020 | 3/5/2019 | Management of Progressive Disease in Idiopathic Pulmonary Fibrosis | Pragmatic Management of Progressive Disease in Idiopathic Pulmonary Fibrosis: a Randomized Trial | Progressive Idiopathic Pulmonary Fibrosis | Drug: pirfenidone and nintedanib;Drug: pirfenidone or nintedanib | Hospices Civils de Lyon | NULL | Recruiting | 50 Years | N/A | All | 378 | Phase 4 | France |
| 13 | 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 | ||
| 14 | 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 |
| 15 | 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 |
| 16 | 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 |
| 17 | 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 | |
| 18 | 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 | ||
| 19 | 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 | ||
| 20 | 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 |
| 21 | 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 |
| 22 | 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 | |
| 23 | 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 | ||
| 24 | 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 | ||
| 25 | 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 |
| 26 | 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 | ||
| 27 | 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 | ||
| 28 | 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 | ||
| 29 | 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 | ||
| 30 | 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 | ||
| 31 | 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 | ||
| 32 | 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 | ||
| 33 | 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 |
| 34 | 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 | ||
| 35 | 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 |
| 36 | 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 | ||
| 37 | 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 |
| 38 | 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 |
| 39 | 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 | ||
| 40 | 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 | ||
| 41 | 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 | ||
| 42 | 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 | ||
| 43 | 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 | ||
| 44 | 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 |
| 45 | 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 |
| 46 | 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 | ||
| 47 | 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 | ||
| 48 | 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 |
| 49 | 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 |
| 50 | NCT02141087 (ClinicalTrials.gov) | July 2014 | 15/5/2014 | Expanded Access Program (EAP): Allow Patients in the US With Idiopathic Pulmonary Fibrosis Access to Pirfenidone | A Treatment Protocol to Allow Patients in the US With Idiopathic Pulmonary Fibrosis Access to Pirfenidone | Idiopathic Pulmonary Fibrosis | Drug: Pirfenidone | Genentech, Inc. | NULL | Approved for marketing | 18 Years | N/A | Both | N/A | NULL | |
| 51 | 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 |
| 52 | 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 | ||
| 53 | 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 | ||
| 54 | 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 | ||
| 55 | 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 | ||
| 56 | 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 |
| 57 | 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 | ||
| 58 | 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 | ||
| 59 | 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 |
| 60 | 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 |
| 61 | 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 | ||
| 62 | 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 | ||
| 63 | 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 | ||
| 64 | 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 | ||
| 65 | 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 | ||
| 66 | 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 |
| 67 | 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 |
| 68 | 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 |
| 69 | 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 |
| 70 | 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 |
| 71 | 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 |
| 72 | 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 |
| 73 | 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 |
| 74 | JPRN-UMIN000005793 | 2009/11/01 | 16/06/2011 | Open-label study of tiotropium/pirfenidone for idiopathic pulmonary fibrosis with emphysema | Open-label study of tiotropium/pirfenidone for idiopathic pulmonary fibrosis with emphysema - PS study | Idiopathic pulmonary fibrosis (IPF) with centrilobular emphysema (CLE) | tiotropium for 8 weeks and then tiotropium + pirfenidone for 44 weeks pirfenidone 44 weeks and then tiotropium + pirfenidone for 8 weeks | Saitama Medical University | NULL | Recruiting | 40years-old | Not applicable | Male and Female | 60 | Not selected | Japan |
| 75 | 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 |
| 76 | 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 |
| 77 | 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 | |||
| 78 | 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 | ||
| 79 | 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 | ||
| 80 | 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 | ||
| 81 | 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 | ||
| 82 | 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 | |||
| 83 | 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 | |||
| 84 | 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 | ||
| 85 | 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 |
| 86 | 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 | ||
| 87 | 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 | ||
| 88 | 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 | ||
| 89 | 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 | ||
| 90 | 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 |
| 91 | 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 |