85. 特発性間質性肺炎 [臨床試験数:514,薬物数:377(DrugBank:108),標的遺伝子数:97,標的パスウェイ数:204

Searched query = "Idiopathic interstitial pneumonia", "IIPs", "Idiopathic pulmonary fibrosis", "IPF", "Usual interstitial pneumonia", "UIP", "Non-specific interstitial pneumonia", "NSIP", "Acute interstitial pneumonia", "AIP", "Diffuse alveolar damage", "DAD", "COP", "Organizing pneumonia", "OP", "Desquamative interstitial pneumonia", "DIP", "Respiratory bronchiolitis - associated interstitial lung disease", "RB-ILD", "Lymphocytic interstitial pneumonia", "LIP"
The queries were searched in Public_title, Scientific_title, and Condition. Export date: 03/15/2021. Trials are sorted by Date_enrollment from most recent to oldest in the table.

Search in Page e.g. "Phase 3", "Not recruiting", "Japan"
435 trials found
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT03720483January 202218/7/2018Inhaled NAC in Treatment of IPFPilot Study to Evaluate Inhaled N-Acetylcysteine in Pulmonary FibrosisIdiopathic Pulmonary Fibrosis (IPF)Drug: N-acetyl cysteine then Placebo;Drug: Placebo then N-acetyl cysteineUniversity of Colorado, DenverNULLNot yet recruiting40 Years75 YearsAll50Phase 1/Phase 2United States
2NCT03800017September 1, 202121/11/2018Skeletal Muscle Function in Interstitial Lung DiseaseInvestigating the Role of Skeletal Muscle Dysfunction on Dyspnea and Exercise Intolerance in Interstitial Lung DiseaseInterstitial Lung Disease;Idiopathic Pulmonary Fibrosis;Hypersensitivity Pneumonitis;Scleroderma;Nonspecific Interstitial PneumoniaBiological: HyperoxiaUniversity of British ColumbiaNULLNot yet recruiting40 Years80 YearsAll40N/ANULL
3NCT04614441December 23, 202029/10/2020NICEFIT-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 TherapyIdiopathic Pulmonary FibrosisDrug: OFEV®Boehringer IngelheimNULLNot yet recruiting20 YearsN/AAll500NULL
4EUCTR2019-002709-23-DE18/12/202031/01/2020A study to assess the efficacy, safety and pharmacokinetics of PLN-74809 inparticipants with idiopathic pulmonary fibrosisA randomized, double-blind, dose-ranging, placebo-controlled Phase 2aevaluation of the safety, tolerability and pharmacokinetics of PLN-74809 inparticipants with idiopathic pulmonary fibrosis (IPF) (INTEGRIS-IPF) Idiopathic pulmonary fibrosis (IPF)
MedDRA version: 21.1Level: PTClassification code 10021240Term: Idiopathic pulmonary fibrosisSystem 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
Pliant Therapeutics Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
84Phase 2United States;France;Canada;Belgium;Australia;Netherlands;Germany;United Kingdom;New Zealand;Italy
5NCT04552899November 27, 202014/9/2020A Study to Evaluate the Efficacy and Safety of Recombinant Human Pentraxin-2 (rhPTX-2; PRM-151) in Participants With Idiopathic Pulmonary FibrosisA Phase III Randomized, Double-blind, Placebo Controlled Trial to Evaluate the Efficacy and Safety of PRM-151 in Patients With Idiopathic Pulmonary FibrosisIdiopathic Pulmonary FibrosisDrug: PRM-151;Drug: PlaceboHoffmann-La RocheNULLRecruiting40 Years85 YearsAll658Phase 3United States
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
6NCT04300920November 20, 20206/3/2020Prospective Treatment Efficacy in IPF Using Genotype for Nac Selection (PRECISIONS) TrialProspective Treatment Efficacy in IPF Using Genotype for Nac Selection (PRECISIONS) TrialIdiopathic Pulmonary FibrosisDrug: N-acetyl cysteine;Drug: PlaceboWeill Medical College of Cornell UniversityUniversity of Virginia;University of Michigan;Pulmonary Fibrosis Foundation;University of Washington;National Heart, Lung, and Blood Institute (NHLBI);Three Lakes FoundationNot yet recruiting40 YearsN/AAll200Phase 3United States
7EUCTR2019-002709-23-GB06/11/202024/01/2020A study to assess the efficacy, safety and pharmacokinetics of PLN-74809 in participants with idiopathic pulmonary fibrosisA 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: 21.1Level: PTClassification code 10021240Term: Idiopathic pulmonary fibrosisSystem 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.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
40Phase 2United States;France;Canada;Belgium;Australia;Netherlands;Germany;New Zealand;Italy;United Kingdom
8EUCTR2019-004167-45-SK02/11/202011/08/2020A 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: 21.1Level: PTClassification code 10021240Term: Idiopathic pulmonary fibrosisSystem 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 KGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
150Phase 2United States;Slovakia;Greece;Finland;Spain;Ukraine;Austria;Russian Federation;Chile;United Kingdom;Italy;Hungary;Mexico;Canada;Argentina;Poland;Australia;Denmark;Netherlands;Germany;Japan;China;Korea, Republic of;Czechia
9NCT04244825November 20203/1/2020Safety, Pharmacodynamics, and Pharmacokinetics of Orally Administered BLD-2660 in Subjects With IPFA Phase 2a, Double-Blind, Placebo-Controlled Study to Evaluate Pharmacodynamics, Pharmacokinetics, and Safety of BLD-2660 Administered Orally in Subjects With Idiopathic Pulmonary FibrosisIdiopathic Pulmonary FibrosisDrug: BLD-2660;Drug: Control: PlaceboBlade TherapeuticsNULLSuspended45 YearsN/AAll32Phase 2United Kingdom
10NCT04429516November 202012/3/2020Morphine Sulfate/Placebo for the Treatment of PulmonAry Fibrosis CoughPAciFy Cough: A Multicentre, Double Blind, Placebo Controlled, Crossover Trial of Morphine Sulfate for the Treatment of PulmonAry Fibrosis CoughIdiopathic Pulmonary FibrosisDrug: Morphine Sulfate;Drug: Placebo oral tabletRoyal Brompton & Harefield NHS Foundation TrustNULLNot yet recruiting40 Years90 YearsAll44Phase 3United Kingdom
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
11EUCTR2020-000697-22-DK13/10/202014/08/2020A 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: 21.1Level: PTClassification code 10021240Term: Idiopathic pulmonary fibrosisSystem 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.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
340Phase 3Serbia;Spain;Ukraine;Ireland;Lebanon;Colombia;United Kingdom;Italy;India;France;Czech Republic;Hungary;Mexico;Poland;Brazil;Dominican Republic;Peru;Denmark;Georgia;Netherlands;Germany
12EUCTR2020-000697-22-DE13/10/202005/08/2020A 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: 21.1Level: PTClassification code 10021240Term: Idiopathic pulmonary fibrosisSystem 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.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
340Phase 3Serbia;Spain;Ukraine;Lebanon;Ireland;Colombia;United Kingdom;Italy;India;France;Czech Republic;Hungary;Mexico;Poland;Belgium;Brazil;Dominican Republic;Peru;Denmark;Bulgaria;Georgia;Norway;Netherlands;Germany
13NCT04534478September 7, 202031/8/2020Oral Prednisone Regimens to Optimize the Therapeutic Strategy in Patients With Organizing Pneumonia Post-COVID-19Randomized, 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 InfectionCOVID-19 PneumoniaDrug: PrednisoneHospital Universitari Vall d'Hebron Research InstituteNULLNot yet recruiting18 YearsN/AAll120Phase 4NULL
14EUCTR2019-004167-45-DK27/08/202012/06/2020A 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 18 mg taken orally. Idiopathic Pulmonary Fibrosis
MedDRA version: 21.1Level: PTClassification code 10021240Term: Idiopathic pulmonary fibrosisSystem 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.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
150Phase 2Spain;Ukraine;Chile;Russian Federation;Italy;France;Australia;Denmark;Netherlands;China;Korea, Republic of;Finland;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Germany;Japan;Slovakia;Greece;United States
15EUCTR2019-004167-45-PL24/08/202014/07/2020A 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: 21.1Level: PTClassification code 10021240Term: Idiopathic pulmonary fibrosisSystem 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 KGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
150Phase 2United States;Greece;Finland;Spain;Ukraine;Austria;Russian Federation;Chile;United Kingdom;Italy;France;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Australia;Denmark;Netherlands;Germany;Japan;China;Korea, Republic of
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
16EUCTR2019-004167-45-GB19/08/202024/06/2020A 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: 21.1Level: PTClassification code 10021240Term: Idiopathic pulmonary fibrosisSystem 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 LimitedNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
150Phase 2United 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
17EUCTR2019-004167-45-HU17/08/202024/06/2020A 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: 21.1Level: PTClassification code 10021240Term: Idiopathic pulmonary fibrosisSystem 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 KGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
150Phase 2United States;Greece;Finland;Spain;Austria;United Kingdom;Italy;France;Hungary;Czech Republic;Mexico;Canada;Poland;Australia;Denmark;Netherlands;Germany;China;Japan;Korea, Republic of
18NCT04312594August 13, 202027/2/2020Jaktinib Dihydrochloride Monohydrate in Idiopathic Pulmonary FibrosisA Multicenter, Randomized, Double-Blind,Placebo-controlled,Phase 2 Trial of Jaktinib Dihydrochloride Monohydrate in Idiopathic Pulmonary FibrosisIdiopathic Pulmonary FibrosisDrug: 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 TabletsSuzhou Zelgen Biopharmaceuticals Co.,LtdNULLRecruiting50 YearsN/AAll90Phase 2China
19NCT04071769August 3, 20209/8/2019Genentech Xenon MRI Idiopathic Pulmonary FibrosisUsing Xenon MRI to Evaluate the Efficacy of Therapies for Idiopathic Pulmonary FibrosisIdiopathic Pulmonary FibrosisDrug: Hyperpolarized 129 Xenon Gas Comparing Idiopathic Pulmonary Fibrosis (IPF) TreatmentDuke UniversityNULLRecruiting18 YearsN/AAll20Phase 2United States
20EUCTR2019-004167-45-DE30/07/202022/06/2020A 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: 21.1Level: PTClassification code 10021240Term: Idiopathic pulmonary fibrosisSystem 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. KGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
150Phase 2United States;Slovakia;Greece;Finland;Spain;Ukraine;Austria;Russian Federation;Chile;United Kingdom;Italy;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Australia;Denmark;Netherlands;Germany;Japan;China;Korea, Republic of
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
21NCT04318704July 29, 202020/3/2020Efficacy, Safety and Tolerability of NP-120 on Idiopathic Pulmonary Fibrosis and Its Associated CoughAn Open Label Study of the Efficacy, Safety and Tolerability of NP-120 on Idiopathic Pulmonary Fibrosis and Its Associated CoughIdiopathic Pulmonary FibrosisDrug: IfenprodilAlgernon PharmaceuticalsNULLRecruitingN/A85 YearsAll20Phase 2Australia;New Zealand
22EUCTR2019-004998-34-GB16/07/202004/02/2020A clinical study to investigate the safety and effects of a new drug called BLD-2660 in patients with Idiopathic Pulmonary FibrosisA 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: 21.1Level: PTClassification code 10021240Term: Idiopathic pulmonary fibrosisSystem 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.NULLNot RecruitingFemale: yes
Male: yes
40Phase 2United Kingdom
23NCT04512170July 13, 20207/8/2020Single and Multiple Dose Safety, Tolerability, PK and Food Effect Study of HEC585 in Healthy Male and Female SubjectsA 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 SubjectsIdiopathic Pulmonary FibrosisDrug: HEC585Sunshine Lake Pharma Co., Ltd.NULLRecruiting18 Years45 YearsAll58Phase 1China
24EUCTR2019-004167-45-NL09/07/202012/05/2020A 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 18 mg taken orally b.i.d. Idiopathic Pulmonary Fibrosis
MedDRA version: 21.1Level: PTClassification code 10021240Term: Idiopathic pulmonary fibrosisSystem 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 IngelheimNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
150Phase 2United States;Slovakia;Greece;Spain;Ukraine;Chile;Russian Federation;Italy;France;Denmark;Australia;Netherlands;China;Korea, Republic of;Finland;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Germany;Japan
25EUCTR2020-000697-22-HU08/07/202022/05/2020A 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: 21.1Level: PTClassification code 10021240Term: Idiopathic pulmonary fibrosisSystem 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.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
340Phase 3Serbia;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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
26EUCTR2020-000822-24-GB06/07/202003/04/2020To 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: 21.1Level: PTClassification code 10021240Term: Idiopathic pulmonary fibrosisSystem 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 ABNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
60Phase 2Ukraine;United Kingdom
27EUCTR2019-003992-21-BE03/07/202004/05/2020A Multicenter, Randomized, Double-blind, Placebo-controlled, Phase 2 Study of the Efficacy and the Safety and Tolerability of BMS-986278 in Participants with Pulmonary FibrosisA 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: 21.0Level: PTClassification code 10037383Term: Pulmonary fibrosisSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
MedDRA version: 21.1Level: PTClassification code 10021240Term: Idiopathic pulmonary fibrosisSystem 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 CorporationNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
360Phase 2United States;Spain;Chile;Israel;United Kingdom;Italy;France;Mexico;Canada;Argentina;Belgium;Brazil;Australia;Germany;Japan;Korea, Republic of
28EUCTR2020-000041-14-GB19/06/202008/07/2020Treating people with Idiopathic Pulmonary fibrosis with the Addition of LansoprazoleThe 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: 21.1Level: PTClassification code 10021240Term: Idiopathic pulmonary fibrosisSystem 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 TrustNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
298Phase 3United Kingdom
29EUCTR2018-002664-73-IE25/05/202020/12/2018Clinical 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: 21.1Level: PTClassification code 10021240Term: Idiopathic pulmonary fibrosisSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
MedDRA version: 20.0Level: LLTClassification code 10067761Term: Exacerbation of idiopathic pulmonary fibrosisSystem 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 ABNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
450Phase 2United States;France;Canada;Spain;Poland;Belgium;Ireland;Israel;Germany;United Kingdom;Italy
30EUCTR2019-003571-19-GB21/05/202027/02/2020A 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: 21.1Level: PTClassification code 10021240Term: Idiopathic pulmonary fibrosisSystem 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 TrustNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
44Phase 3United Kingdom
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
31EUCTR2019-004167-45-FI18/05/202015/04/2020A 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: 21.1Level: PTClassification code 10021240Term: Idiopathic pulmonary fibrosisSystem 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 KyNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
150Phase 2United States;Czechia;Slovakia;Greece;Finland;Spain;Ukraine;Austria;Russian Federation;Chile;United Kingdom;Italy;Hungary;Mexico;Canada;Argentina;Poland;Australia;Denmark;Netherlands;Germany;Japan;China;Korea, Republic of
32NCT04326036March 25, 202026/3/2020Use of cSVF Via IV Deployment for Residual Lung Damage After Symptomatic COVID-19 InfectionUse of cSVF For Residual Lung Damage (COPD/Fibrotic Lung Disease After Symptomatic COVID-19 Infection For Residual Pulmonary Injury or Post-Adult Respiratory Distress Syndrome Following Viral (SARS-Co-2) InfectionPulmonary Alveolar Proteinosis;COPD;Idiopathic Pulmonary Fibrosis;Viral Pneumonia;Coronavirus Infection;Interstitial Lung DiseaseProcedure: Microcannula Harvest Adipose Derived tissue stromal vascular fraction (tSVF);Device: Centricyte 1000;Procedure: IV Deployment Of cSVF In Sterile Normal Saline IV Solution;Drug: Liberase Enzyme (Roche);Drug: Sterile Normal Saline for Intravenous UseBlack Tie Medical, Inc.Robert W. Alexander, MDRecruiting18 Years90 YearsAll10Early Phase 1United States
33NCT04396756March 3, 20206/5/2020Evaluation of Efficacy and Safety of PLN-74809 in Patients With Idiopathic Pulmonary FibrosisA 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 (INTEGRIS-IPF)Idiopathic Pulmonary FibrosisDrug: PLN-74809;Drug: PlaceboPliant Therapeutics, Inc.NULLRecruiting40 YearsN/AAll84Phase 2United States;Canada
34EUCTR2019-004326-19-FR27/01/202013/11/2019Management 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]
Hospices Civils de LyonNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
378 Human pharmacology (Phase 1): no Therapeut1c exploratory (Phase 2): no Therapeut1c conf1rmatory - (Phase 3): yes Therapeut1c use (Phase 4): noFrance
35ChiCTR20000376022020-01-012020-08-29Clinical observation and study of pirfenidone combined with dextromethorphan on idiopathic pulmonary fibrosisClinical observation and study of pirfenidone combined with dextromethorphan on idiopathic pulmonary fibrosis Interstitial lung disease1:Dextromethorphan+Pirfenidone;2:Pirfenidone;Tianjin Medical University General HospitalNULLRecruiting1875Both1:100;2:100;China
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
36ChiCTR19000271212019-10-282019-11-01The efficacy and safety of immunosuppressant in the treatment of nonspecific interstitial pneumonia (NSIP): a prospective, single-center, open, parallel-controlled trialThe 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 HospitalNULLRecruiting1875BothGroup-1:30;Group-2:30;Group-3:30;Control group:30;China
37JPRN-jRCTs03119011928/10/201918/10/2019A phase II Study of CBDCA + ETP + Nintedanib for SCLC with IPFA 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 fibrosisThe 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 SatoshiOGURA Takashi;Thoracic Oncology Research GroupRecruiting>= 20age oldNot applicableBoth33Phase 2Japan
38EUCTR2018-002664-73-GB24/09/201922/01/2019Clinical 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: 21.1Level: PTClassification code 10021240Term: Idiopathic pulmonary fibrosisSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
MedDRA version: 20.0Level: LLTClassification code 10067761Term: Exacerbation of idiopathic pulmonary fibrosisSystem 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 ABNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
450Phase 2United States;France;Canada;Spain;Poland;Belgium;Ireland;Israel;Germany;Italy;United Kingdom
39NCT04030026August 8, 201911/7/2019A Study of Nalbuphine (Extended Release) ER in Idiopathic Pulmonary Fibrosis (IPF) for Treatment of CoughPhase 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 CoughNalbuphine;Idiopathic Pulmonary Fibrosis;CoughDrug: Nalbuphine ER;Drug: Placebo oral tabletTrevi TherapeuticsParexelRecruiting18 Years80 YearsAll60Phase 2United Kingdom
40EUCTR2018-002664-73-PL09/07/201914/03/2019Clinical 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: 21.1Level: PTClassification code 10021240Term: Idiopathic pulmonary fibrosisSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
MedDRA version: 20.0Level: LLTClassification code 10067761Term: Exacerbation of idiopathic pulmonary fibrosisSystem 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 ABNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
450Phase 2Israel;Germany;United Kingdom;Italy;United States;France;Canada;Spain;Belgium;Poland;Ireland
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
41EUCTR2018-002664-73-FR09/07/201922/01/2019Clinical 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]
Galecto Biotech ABNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
450 Human pharmacology (Phase 1): no Therapeut1c exploratory (Phase 2): yes Therapeut1c conf1rmatory - (Phase 3): no Therapeut1c use (Phase 4): noUnited States;France;Canada;Poland;Belgium;Spain;Israel;Germany;Italy;United Kingdom
42NCT03562416July 5, 20197/5/2018Continuation of Nintedanib After Single Lung Transplantation in IPF SubjectsNintedanib Plus Usual Transplant Care Compared to Usual Transplant Care Alone After Single Lung Transplantation in Patients With Idiopathic Pulmonary Fibrosis: a Pilot Randomized Controlled TrialIdiopathic Pulmonary Fibrosis;Lung Transplant; ComplicationsDrug: Nintedanib;Drug: Placebo Oral TabletTemple UniversityBoehringer IngelheimRecruiting35 Years70 YearsAll20Phase 2United States
43EUCTR2018-004447-23-DE04/07/201907/03/2019Efficacy 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: 21.1Level: LLTClassification code 10070801Term: Persistent coughSystem 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 GmbHNULLNot RecruitingFemale: yes
Male: yes
180Phase 2United States;Czech Republic;Canada;Belgium;Turkey;Netherlands;Germany;United Kingdom;Italy
44EUCTR2018-004744-31-GB24/06/201905/03/2019Efficacy and Safety Study: Nalbuphine ER Tablets for the Treatment of Cough in Idiopathic Pulmonary FibrosisA 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.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
60Phase 2United Kingdom
45EUCTR2018-004447-23-IT18/06/201910/11/2020Efficacy 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: 21.1Level: LLTClassification code 10070801Term: Persistent coughSystem 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, GmbHNULLNot RecruitingFemale: yes
Male: yes
180Phase 2United States;Czechia;Czech Republic;Canada;Belgium;Turkey;Australia;Netherlands;Germany;United Kingdom;New Zealand;Italy
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
46EUCTR2018-001405-87-BE27/05/201928/11/2018A clinical study to test how effective and safe GLPG1690 is for subjects with idiopathic pulmonary fibrosis (IPF) when used together with standard medical treatmentA 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: 20.0Level: SOCClassification code 10038738Term: Respiratory, thoracic and mediastinal disordersSystem 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 NVNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
750Phase 3United States;Taiwan;Greece;Finland;Spain;Turkey;Chile;United Kingdom;Czech Republic;Belgium;Brazil;Australia;Denmark;Peru;Germany
47EUCTR2018-004447-23-GB20/05/201915/03/2019Efficacy 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: 21.1Level: LLTClassification code 10070801Term: Persistent coughSystem 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 GmbHNULLNot RecruitingFemale: yes
Male: yes
180Phase 2United States;Czech Republic;Canada;Belgium;Turkey;Australia;Netherlands;Germany;New Zealand;Italy;United Kingdom
48EUCTR2018-004447-23-CZ15/05/201914/03/2019Efficacy 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: 21.1Level: LLTClassification code 10070801Term: Persistent coughSystem 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 GmbHNULLNot RecruitingFemale: yes
Male: yes
180Phase 2United States;Czech Republic;Canada;Belgium;Turkey;Australia;Netherlands;Germany;United Kingdom;New Zealand;Italy
49NCT03981094May 10, 201921/5/2019A Study of the Pharmacokinetic Interaction Between Pirfenidone and BMS-986278 in Healthy ParticipantsAn Open Label Study to Assess the Pharmacokinetic Interaction Between Pirfenidone and BMS-986278 Following a Single Oral Dose Administration in Healthy ParticipantsIdiopathic Pulmonary Fibrosis (IPF)Drug: BMS-986278;Drug: PirfenidoneBristol-Myers SquibbNULLCompleted21 Years65 YearsAll22Phase 1United States
50EUCTR2018-004447-23-BE02/05/201901/04/2019Efficacy 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: 21.1Level: LLTClassification code 10070801Term: Persistent coughSystem 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 GmbHNULLNot RecruitingFemale: yes
Male: yes
180Phase 2United States;Czech Republic;Canada;Belgium;Turkey;Australia;Netherlands;Germany;United Kingdom;New Zealand;Italy
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
51EUCTR2017-003158-18-DE30/04/201921/06/2018Evaluating the Efficacy and Safety of BG00011 in Participants with Idiopathic Pulmonary FibrosisA 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]
Biogen Idec Research LimitedNULLNot Recruiting Female: yes
Male: yes
290 Human pharmacology (Phase 1): no Therapeut1c exploratory (Phase 2): yes Therapeut1c conf1rmatory - (Phase 3): no Therapeut1c use (Phase 4): noUnited States;Greece;Spain;Turkey;Russian Federation;Israel;Italy;United Kingdom;France;Czech Republic;Canada;Argentina;Poland;Belgium;Australia;Denmark;Netherlands;Germany;Korea, Republic of
52EUCTR2018-004447-23-NL16/04/201907/03/2019Efficacy 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: 20.0 Level: LLT Classification code 10070801 Term: Persistent cough System Organ Class: 100000004855 ;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Respivant Sciences GmbHNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
180 Human pharmacology (Phase 1): no Therapeut1c exploratory (Phase 2): yes Therapeut1c conf1rmatory - (Phase 3): no Therapeut1c use (Phase 4): noUnited States;Czech Republic;Canada;Belgium;Turkey;Germany;Netherlands;Italy;United Kingdom
53EUCTR2018-002664-73-ES08/04/201912/04/2019Clinical 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]
Galecto Biotech ABNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
450 Human pharmacology (Phase 1): no Therapeut1c exploratory (Phase 2): yes Therapeut1c conf1rmatory - (Phase 3): no Therapeut1c use (Phase 4): noFrance;United States;Canada;Poland;Belgium;Spain;Ireland;Israel;Germany;Italy;United Kingdom
54EUCTR2018-001406-29-NL03/04/201906/12/2018A clinical study to test how effective and safe GLPG1690 is for subjects with idiopathic pulmonary fibrosis (IPF) when used together with standard medical treatmentA 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]
Galapagos NVNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
750 Human pharmacology (Phase 1): no Therapeut1c exploratory (Phase 2): no Therapeut1c conf1rmatory - (Phase 3): yes Therapeut1c use (Phase 4): noUnited States;Israel;Italy;France;Hungary;Mexico;Canada;Argentina;Poland;Brazil;South Africa;Netherlands;Germany;New Zealand;Korea, Republic of
55NCT03864328March 29, 20192/3/2019A Phase 2b Study of Inhaled RVT-1601 for the Treatment of Persistent Cough in IPFRandomized, 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 TrialPersistent Cough in IPF;Chronic Cough;IPFDrug: RVT-1601;Drug: PlaceboRespivant Sciences GmbHRespivant Sciences Inc.Terminated40 Years89 YearsAll108Phase 2United States;Australia;Belgium;Canada;Czechia;Germany;Italy;Netherlands;New Zealand;Turkey;United Kingdom
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
56EUCTR2018-001405-87-GB29/03/201905/12/2018A clinical study to test how effective and safe GLPG1690 is for subjects with idiopathic pulmonary fibrosis (IPF) when used together with standard medical treatmentA 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: 20.0Level: SOCClassification code 10038738Term: Respiratory, thoracic and mediastinal disordersSystem 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 NVNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
750Phase 3United States;Czechia;Taiwan;Greece;Finland;Spain;Turkey;Chile;United Kingdom;Czech Republic;Belgium;Brazil;Australia;Denmark;Peru;Germany
57EUCTR2018-001405-87-DE21/03/201926/11/2018A clinical study to test how effective and safe GLPG1690 is for subjects with idiopathic pulmonary fibrosis (IPF) when used together with standard medical treatmentA 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: 20.0Level: SOCClassification code 10038738Term: Respiratory, thoracic and mediastinal disordersSystem 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 NVNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
750Phase 3United States;Taiwan;Greece;Finland;Spain;Turkey;Chile;United Kingdom;Czech Republic;Belgium;Brazil;Australia;Denmark;Peru;Germany
58EUCTR2017-004302-18-FI05/03/201904/09/2018A 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: 21.1Level: PTClassification code 10021240Term: Idiopathic pulmonary fibrosisSystem 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 NVNULLNot RecruitingFemale: yes
Male: yes
60Phase 2France;Egypt;Slovakia;Finland;Ukraine;Oman;Romania;Croatia;Bulgaria;Sweden
59NCT03650075February 25, 201920/8/2018To Determine Safety and Tolerability of MG-S-2525 and to Evaluate Its PK Profile in Healthy VolunteersA Phase I Study to Determine Safety and Tolerability of MG-S-2525 and to Evaluate Its Pharmacokinetic Profile in Healthy VolunteersIdiopathic Pulmonary Fibrosis (IPF)Drug: MG-S-2525Metagone Biotech Inc.NULLCompleted20 YearsN/AAll81Phase 1Taiwan
60EUCTR2018-001405-87-GR21/02/201922/01/2019A clinical study to test how effective and safe GLPG1690 is for subjects with idiopathic pulmonary fibrosis (IPF) when used together with standard medical treatmentA 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: 20.0Level: SOCClassification code 10038738Term: Respiratory, thoracic and mediastinal disordersSystem 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 NVNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
750Phase 3United States;Taiwan;Greece;Finland;Spain;Turkey;Chile;United Kingdom;Czech Republic;Belgium;Brazil;Australia;Denmark;Peru;Germany
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
61EUCTR2017-003158-18-PL18/02/201930/11/2018Evaluating the Efficacy and Safety of BG00011 in Participants with Idiopathic Pulmonary FibrosisA 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]
Biogen Idec Research LimitedNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
290 Human pharmacology (Phase 1): no Therapeut1c exploratory (Phase 2): yes Therapeut1c conf1rmatory - (Phase 3): no Therapeut1c use (Phase 4): noUnited States;Greece;Spain;Turkey;Russian Federation;Israel;Italy;United Kingdom;France;Czech Republic;Canada;Argentina;Poland;Belgium;Australia;Denmark;Netherlands;Germany;Korea, Republic of
62NCT03830125February 13, 201931/1/2019Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of BBT-877 in Healthy SubjectsA 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 SubjectsIdiopathic Pulmonary FibrosisDrug: BBT-877, Single dose;Drug: Placebo group;Drug: BBT-877, Multiple dosesBridge Biotherapeutics, Inc.KCRN Research, LLCCompleted19 Years55 YearsAll88Phase 1United States
63NCT03958071February 1, 201920/5/2019A Study Based on Medical Records That Looks at the Characteristics of Idiopathic Pulmonary Fibrosis Patients Grouped by the Type of Medication They Are TakingCharacteristics of IPF Patients Initiating Nintedanib, Pirfenidone or no Antifibrotic Treatment in the USIdiopathic Pulmonary FibrosisDrug: Nintedanib;Drug: Pirfenidone;Other: Untreated CohortBoehringer IngelheimNULLCompleted40 YearsN/AAll13264United States
64EUCTR2018-001406-29-FR28/01/201929/11/2018A clinical study to test how effective and safe GLPG1690 is for subjects with idiopathic pulmonary fibrosis (IPF) when used together with standard medical treatmentA 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]
Galapagos NVNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
750 Human pharmacology (Phase 1): no Therapeut1c exploratory (Phase 2): no Therapeut1c conf1rmatory - (Phase 3): yes Therapeut1c use (Phase 4): noUnited States;Israel;Italy;France;Hungary;Mexico;Canada;Argentina;Poland;Brazil;South Africa;Germany;Netherlands;New Zealand;Korea, Republic of
65EUCTR2018-001405-87-CZ23/01/201906/12/2018A clinical study to test how effective and safe GLPG1690 is for subjects with idiopathic pulmonary fibrosis (IPF) when used together with standard medical treatmentA 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: 20.0Level: SOCClassification code 10038738Term: Respiratory, thoracic and mediastinal disordersSystem 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 NVNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
750Phase 3United States;Taiwan;Greece;Finland;Spain;Turkey;Chile;United Kingdom;Czech Republic;Belgium;Brazil;Australia;Denmark;Peru;Germany
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
66EUCTR2018-001406-29-HU17/01/201904/12/2018A clinical study to test how effective and safe GLPG1690 is for subjects with idiopathic pulmonary fibrosis (IPF) when used together with standard medical treatmentA 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: 20.0Level: SOCClassification code 10038738Term: Respiratory, thoracic and mediastinal disordersSystem 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 NVNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
750Phase 3United States;Israel;Italy;France;Hungary;Mexico;Canada;Argentina;Poland;Brazil;South Africa;Netherlands;Germany;New Zealand;Japan;Korea, Republic of
67EUCTR2017-004302-18-HR14/01/201916/05/2019A 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: 20.0Level: PTClassification code 10021240Term: Idiopathic pulmonary fibrosisSystem 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 NVNULLNot RecruitingFemale: yes
Male: yes
60Phase 2France;Egypt;Slovakia;Finland;Ukraine;Oman;Romania;Croatia;Bulgaria;Sweden
68EUCTR2018-001406-29-PL21/12/201817/12/2018A clinical study to test how effective and safe GLPG1690 is for subjects with idiopathic pulmonary fibrosis (IPF) when used together with standard medical treatmentA 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: 20.0Level: SOCClassification code 10038738Term: Respiratory, thoracic and mediastinal disordersSystem 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 NVNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
750Phase 3United States;Israel;Italy;France;Hungary;Mexico;Canada;Argentina;Poland;Brazil;South Africa;Germany;Netherlands;New Zealand;Japan;Korea, Republic of
69EUCTR2018-001405-87-DK20/12/201822/11/2018A clinical study to test how effective and safe GLPG1690 is for subjects with idiopathic pulmonary fibrosis (IPF) when used together with standard medical treatmentA 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: 20.0Level: SOCClassification code 10038738Term: Respiratory, thoracic and mediastinal disordersSystem 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 NVNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
750Phase 3United States;Taiwan;Greece;Finland;Spain;Turkey;Chile;United Kingdom;Czech Republic;Belgium;Brazil;Denmark;Australia;Peru;Germany
70EUCTR2018-001405-87-ES12/12/201818/01/2019A clinical study to test how effective and safe GLPG1690 is for subjects with idiopathic pulmonary fibrosis (IPF) when used together with standard medical treatmentA 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]
Galapagos NVNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
750 Human pharmacology (Phase 1): no Therapeut1c exploratory (Phase 2): no Therapeut1c conf1rmatory - (Phase 3): yes Therapeut1c use (Phase 4): noUnited States;Taiwan;Greece;Finland;Spain;Turkey;Chile;United Kingdom;Czech Republic;Belgium;Peru;Australia;Denmark;Germany
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
71EUCTR2017-004302-18-SE03/12/201801/08/2018A 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: 21.1Level: PTClassification code 10021240Term: Idiopathic pulmonary fibrosisSystem 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 NVNULLNot RecruitingFemale: yes
Male: yes
60Phase 2France;Egypt;Slovakia;Finland;Ukraine;Oman;Romania;Croatia;Bulgaria;Sweden
72EUCTR2017-004919-39-DE20/11/201816/07/2018A 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: 21.1Level: PTClassification code 10021240Term: Idiopathic pulmonary fibrosisSystem 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 CorporationNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
120Phase 2United States;Germany;United Kingdom;Japan
73EUCTR2017-003158-18-DK15/11/201816/05/2018Evaluating the Efficacy and Safety of BG00011 in Participants with Idiopathic Pulmonary FibrosisA 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: 20.0Level: PTClassification code 10021240Term: Idiopathic pulmonary fibrosisSystem 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 LimitedNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
290Phase 2United States;Greece;Spain;Turkey;Russian Federation;Israel;Italy;United Kingdom;France;Czech Republic;Canada;Argentina;Poland;Belgium;Denmark;Australia;Netherlands;Germany;Korea, Republic of
74EUCTR2018-002632-24-FR13/11/201820/07/2018to 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 pulmonaryTherapeutic 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]ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP)NULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
40 Human pharmacology (Phase 1): no Therapeut1c exploratory (Phase 2): no Therapeut1c conf1rmatory - (Phase 3): yes Therapeut1c use (Phase 4): noFrance
75EUCTR2017-004302-18-BG22/10/201806/08/2018A 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: 21.1Level: PTClassification code 10021240Term: Idiopathic pulmonary fibrosisSystem 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 NVNULLNot RecruitingFemale: yes
Male: yes
60Phase 2France;Egypt;Slovakia;Finland;Ukraine;Oman;Romania;Croatia;Bulgaria;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
76NCT03711435October 20, 20187/10/2018Traditional Chinese Medicine(TCM) Syndrome Classification of Idiopathic Pulmonary Fibrosis(IPF) and MetabolomicsStudy on TCM Syndrome Classification of Idiopathic Pulmonary Fibrosis Based on MetabolomicsIdiopathic Pulmonary FibrosisDiagnostic Test: Metabolomics;Drug: Traditional Chinese Medicine FormulationXuzhou Traditional Chinese Medicine HospitalNULLCompleted50 Years85 YearsAll60China
77EUCTR2017-003158-18-NL10/10/201824/05/2018Evaluating the Efficacy and Safety of BG00011 in Participants with Idiopathic Pulmonary FibrosisA 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: 20.0Level: PTClassification code 10021240Term: Idiopathic pulmonary fibrosisSystem 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 LimitedNULLNot RecruitingFemale: yes
Male: yes
290Phase 2United States;Greece;Spain;Turkey;Russian Federation;Israel;United Kingdom;Italy;France;Czech Republic;Canada;Argentina;Poland;Belgium;Australia;Denmark;Netherlands;Germany;Korea, Republic of
78NCT03725852September 27, 20188/6/2018A 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 FibrosisIdiopathic Pulmonary FibrosisDrug: GLPG1205;Drug: PlaceboGalapagos NVNULLCompleted40 YearsN/AAll69Phase 2Bulgaria;Croatia;Finland;France;Oman;Romania;Slovakia;Sweden;Ukraine
79EUCTR2017-003158-18-BE26/09/201829/05/2018Evaluating the Efficacy and Safety of BG00011 in Participants with Idiopathic Pulmonary FibrosisA 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]
Biogen Idec Research LimitedNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
290 Human pharmacology (Phase 1): no Therapeut1c exploratory (Phase 2): yes Therapeut1c conf1rmatory - (Phase 3): no Therapeut1c use (Phase 4): noUnited States;Greece;Spain;Turkey;Russian Federation;Israel;Italy;United Kingdom;France;Czech Republic;Canada;Argentina;Poland;Belgium;Australia;Denmark;Netherlands;Germany;Korea, Republic of
80EUCTR2017-003158-18-GR21/09/201825/05/2018Evaluating the Efficacy and Safety of BG00011 in Participants with Idiopathic Pulmonary FibrosisA 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: 20.0Level: PTClassification code 10021240Term: Idiopathic pulmonary fibrosisSystem 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 LimitedNULLNot RecruitingFemale: yes
Male: yes
290Phase 2United States;Greece;Spain;Turkey;Russian Federation;Israel;Italy;United Kingdom;France;Czech Republic;Canada;Argentina;Poland;Belgium;Australia;Denmark;Netherlands;Germany;Korea, Republic of
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
81EUCTR2017-003158-18-GB18/09/201810/05/2018Evaluating the Efficacy and Safety of BG00011 in Participants with Idiopathic Pulmonary FibrosisA 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]
Biogen Idec Research LimitedNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
290 Human pharmacology (Phase 1): no Therapeut1c exploratory (Phase 2): yes Therapeut1c conf1rmatory - (Phase 3): no Therapeut1c use (Phase 4): noUnited States;Greece;Spain;Turkey;Russian Federation;Israel;Italy;United Kingdom;France;Czech Republic;Canada;Argentina;Poland;Belgium;Australia;Denmark;Netherlands;Germany;Korea, Republic of
82EUCTR2017-003158-18-CZ12/09/201809/05/2018Evaluating the Efficacy and Safety of BG00011 in Participants with Idiopathic Pulmonary FibrosisA 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: 20.0Level: PTClassification code 10021240Term: Idiopathic pulmonary fibrosisSystem 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 LimitedNULLNot RecruitingFemale: yes
Male: yes
290Phase 2United States;Greece;Spain;Turkey;Russian Federation;Israel;Italy;United Kingdom;France;Czech Republic;Canada;Argentina;Poland;Belgium;Australia;Denmark;Netherlands;Germany;Korea, Republic of
83EUCTR2017-003158-18-IT03/09/201805/11/2020Evaluating the Efficacy and Safety of BG00011 in Participants with Idiopathic Pulmonary FibrosisA 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: 21.1Level: PTClassification code 10021240Term: Idiopathic pulmonary fibrosisSystem 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 LIMITEDNULLNot RecruitingFemale: yes
Male: yes
290Phase 2United 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
84EUCTR2017-003158-18-ES27/07/201805/06/2018Evaluating the Efficacy and Safety of BG00011 in Participants with Idiopathic Pulmonary FibrosisA 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: 20.0Level: PTClassification code 10021240Term: Idiopathic pulmonary fibrosisSystem 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 LimitedNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
290Phase 2United States;Greece;Spain;Turkey;Russian Federation;Israel;Italy;United Kingdom;France;Czech Republic;Canada;Argentina;Poland;Belgium;Australia;Denmark;Netherlands;Germany;Korea, Republic of
85NCT03619616July 16, 201823/7/2018Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Single Ascending Dose of ZSP1603 in Healthy AdultsA Phase 1 Randomized,Double-Blind,Parallel-Group, Placebo-Controlled Study to Evaluate the Safety, Tolerability and Pharmacokinetics of ZSP1603 in Chinese Healthy SubjectsIdiopathic Pulmonary Fibrosis(IPF);Solid TumorDrug: 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 50mgGuangdong Zhongsheng Pharmaceutical Co., Ltd.NULLCompleted18 Years50 YearsAll40Phase 1China
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
86EUCTR2017-004923-63-GB10/07/201820/12/2017A 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]
Vicore Pharma ABNULLNot Recruiting Female: yes
Male: yes
30 Human pharmacology (Phase 1): no Therapeut1c exploratory (Phase 2): yes Therapeut1c conf1rmatory - (Phase 3): no Therapeut1c use (Phase 4): noSerbia;Poland;Bulgaria;United Kingdom
87NCT03538301June 18, 20182/5/2018JUNIPER: A Phase 2 Study to Evaluate the Safety, Biological Activity, and PK of ND-L02-s0201 in Subjects With IPFA 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 FibrosisDrug: ND-L02-s0201;Other: Other: PlaceboNitto Denko CorporationNULLRecruiting40 Years80 YearsAll120Phase 2United States;Germany;Japan;United Kingdom
88EUCTR2017-004302-18-SK18/06/201804/05/2018A 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: 20.0Level: PTClassification code 10021240Term: Idiopathic pulmonary fibrosisSystem 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 NVNULLNot RecruitingFemale: yes
Male: yes
60Phase 2France;Egypt;Slovakia;Finland;Ukraine;Oman;Romania;Croatia;Bulgaria;Sweden
89EUCTR2017-002667-17-FR06/06/201820/02/2018Study of pharmacodynamics, pharmacokinetics, safety and tolerability of VAY736 in patients with idiopathic pulmonary fibrosisA 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]
Novartis Pharma AGNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
84 Human pharmacology (Phase 1): no Therapeut1c exploratory (Phase 2): yes Therapeut1c conf1rmatory - (Phase 3): no Therapeut1c use (Phase 4): noUnited States;France;Canada;Ireland;Germany;Italy;United Kingdom
90EUCTR2017-002667-17-DE04/06/201823/01/2018Study of pharmacodynamics, pharmacokinetics, safety and tolerability of VAY736 in patients with idiopathic pulmonary fibrosisA 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: 21.1Level: PTClassification code 10021240Term: Idiopathic pulmonary fibrosisSystem 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 AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
58Phase 2United States;France;Canada;Ireland;Germany;United Kingdom;Italy
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
91EUCTR2016-003827-45-GR29/05/201816/05/2018AN OPEN LABEL PHASE IV, MULTICENTER, INTERNATIONAL, INTERVENTIONAL STUDY TO EVALUATE THE EFFECT OF DIET ON GASTROINTESTINAL ADVERSE EVENTS IN PATIENTS WITH IPF TREATED WITH PIRFENIDONEAN 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: 20.0Level: PTClassification code 10021240Term: Idiopathic pulmonary fibrosisSystem 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 IIIInstitut d'Investigació Biomédica de Bellvitge (IDIBELL)Not RecruitingFemale: yes
Male: yes
90Phase 4Greece;Spain;United Kingdom
92NCT03502902May 22, 201810/4/2018The Safety, Tolerability and Pharmacokinetic Study of HEC68498 in Healthy Male and Female SubjectsHEC68498 - 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 SubjectsIdiopathic Pulmonary FibrosisDrug: HEC 68498;Drug: PlaceboSunshine Lake Pharma Co., Ltd.CovanceUnknown status18 Years60 YearsAll72Phase 1United States
93EUCTR2017-002667-17-GB18/05/201808/11/2017Study of pharmacodynamics, pharmacokinetics, safety and tolerability of VAY736 in patients with idiopathic pulmonary fibrosisA 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: 21.1Level: PTClassification code 10021240Term: Idiopathic pulmonary fibrosisSystem 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 AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
58Phase 2United States;France;Canada;Ireland;Germany;Italy;United Kingdom
94EUCTR2016-003827-45-GB15/05/201801/02/2018AN OPEN LABEL PHASE IV, MULTICENTER, INTERNATIONAL, INTERVENTIONAL STUDY TO EVALUATE THE EFFECT OF DIET ON GASTROINTESTINAL ADVERSE EVENTS IN PATIENTS WITH IPF TREATED WITH PIRFENIDONEAN 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]
CIBER - Instituto Carlos IIIInstitut d'Investigació Biomédica de Bellvitge (IDIBELL)Authorised-recruitment may be ongoing or finished Female: yes
Male: yes
90 Human pharmacology (Phase 1): no Therapeut1c exploratory (Phase 2): no Therapeut1c conf1rmatory - (Phase 3): no Therapeut1c use (Phase 4): yesGreece;Spain;United Kingdom
95NCT03500731April 19, 201830/3/2018Lung and Bone Marrow Transplantation for Lung and Bone Marrow FailureLung Transplant in Tandem With Bone Marrow Transplant for Combined Lung and Bone Marrow FailureIdiopathic Pulmonary Fibrosis;Emphysema or COPDBiological: CD3/CD19 negative hematopoietic stem cells;Drug: Rituximab;Drug: Alemtuzumab;Drug: Fludarabine;Drug: Thiotepa;Drug: G-CSF;Drug: HydroxyureaPaul SzabolcsNULLRecruiting18 Years60 YearsAll8Phase 1/Phase 2United States
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
96EUCTR2017-002667-17-IE06/04/201808/11/2017Study of pharmacodynamics, pharmacokinetics, safety and tolerability of VAY736 in patients with idiopathic pulmonary fibrosisA 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: 21.1Level: PTClassification code 10021240Term: Idiopathic pulmonary fibrosisSystem 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 AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
58Phase 2United States;France;Canada;Ireland;Germany;United Kingdom;Italy
97NCT03422068March 16, 201822/1/2018This 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 FibrosisDrug: BI 1015550;Drug: PlaceboBoehringer IngelheimNULLCompleted40 YearsN/AAll15Phase 1Belgium;Denmark;Finland;Germany;Italy;Netherlands;Spain;United Kingdom;France
98NCT02871401January 3, 201815/8/2016A 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 FibrosisDrug: Valganciclovir;Drug: PlaceboVanderbilt University Medical CenterGenentech, Inc.Completed21 Years80 YearsAll31Phase 1United States
99NCT03183570November 8, 20178/5/2017Detection of Integrin avb6 in IPF, PSC, and COVID19 Using PET/CTDetection of Integrin avb6 in Idiopathic Pulmonary Fibrosis, Primary Sclerosing Cholangitis, and Coronavirus Disease 2019 With [18F]FP-R01-MG-F2 With PET/CTIdiopathic Pulmonary Fibrosis;Primary Sclerosing Cholangitis;Covid19 PneumoniaDrug: [18F]FP-R01-MG-F2Stanford UniversityPliant Therapeutics, Inc.Recruiting18 YearsN/AAll30Early Phase 1United States
100NCT03281200October 24, 201711/9/2017Chart Review Study to Describe the Clinical Profile of Idiopathic Pulmonary Fibrosis (IPF) Patients Treated With Nintedanib (OFEV®) in Real-world Practice in SpainA 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 FibrosisDrug: L - Antineoplastic and immunomodulating agents;Drug: L01 - Antineoplastic agents;Drug: L01X - Other antineoplastic agents;Drug: L01XE - Protein kinase inhibitors;Drug: L01XE31 - NintedanibBoehringer IngelheimNULLCompleted18 YearsN/AAll172Spain
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
101NCT03208933October 23, 201726/6/2017Open-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 PracticeIdiopathic Pulmonary FibrosisDrug: PirfenidoneHoffmann-La RocheNULLCompleted40 Years80 YearsAll60Phase 3Russian Federation
102JPRN-UMIN0000294112017/10/1515/10/2017Phase 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 non-small-cell lung cancer combined with idiopathic pulmonary fibrosisOral 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 GroupNULLRecruiting20years-oldNot applicableMale and Female230Phase 3Japan
103EUCTR2016-003473-17-GB14/09/201724/02/2017Investigation 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]
Celgene CorporationNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
210 Human pharmacology (Phase 1): no Therapeut1c exploratory (Phase 2): yes Therapeut1c conf1rmatory - (Phase 3): no Therapeut1c use (Phase 4): noUnited States;Taiwan;Greece;Turkey;Russian Federation;Colombia;United Kingdom;France;Canada;Brazil;Romania;Australia;Germany
104EUCTR2017-001276-27-GB21/08/201703/05/2017A 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]
Global Blood Therapeutics Inc.NULLNot Recruiting Female: yes
Male: yes
32 Human pharmacology (Phase 1): no Therapeut1c exploratory (Phase 2): yes Therapeut1c conf1rmatory - (Phase 3): no Therapeut1c use (Phase 4): noUnited States;United Kingdom
105EUCTR2015-002619-14-FR21/06/201725/04/2018Efficacy and safety of nintedanib co-administered with sildenafil in IPF patients with advanced lung function impairmentA 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: 20.0Level: PTClassification code 10021240Term: Idiopathic pulmonary fibrosisSystem 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 FranceNULLNot RecruitingFemale: yes
Male: yes
300Phase 3United States;Spain;Italy;United Kingdom;India;France;Mexico;Canada;Belgium;Australia;Germany;China;Japan;Korea, Republic of
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
106NCT03092102May 20, 201721/3/2017The Safety, Tolerability and Pharmacokinetic Study of HEC585 in Healthy Male and Female SubjectsA Phase I, Double-blind, Placebo-controlled, Single and Multiple Oral Dose, Safety, Tolerability and Pharmacokinetic Study of HEC585 in Healthy Male and Female SubjectsIdiopathic Pulmonary FibrosisDrug: HEC585Sunshine Lake Pharma Co., Ltd.NULLCompleted18 Years60 YearsAll136Phase 1United States
107JPRN-UMIN0000267992017/05/1201/04/2017A randomized phse 3 study of carboplatin plus nab-paclitaxel with or without nintedanib for advanced non-small-cell lung cancer with idiopathic pulmonary fibrosisA 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 fibrosisA: 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 UniversityNULLComplete: follow-up continuing20years-oldNot applicableMale and Female240Phase 3Japan
108EUCTR2016-003473-17-GR05/05/201702/03/2017Investigation to Efficacy and Safety of CC-90001 in patients with Idiopathic Pulmonary FibrosisA 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: 20.0Level: LLTClassification code 10067761Term: Exacerbation of idiopathic pulmonary fibrosisSystem Organ Class: 100000004855;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Code: CC-90001Celgene CorporationNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
135Phase 2United States;Taiwan;Greece;Turkey;Russian Federation;Colombia;United Kingdom;France;Canada;Brazil;Romania;Australia;Germany
109NCT03115619April 18, 201712/4/2017Quality of Life Study in Participants With IPF Under Pirfenidone TreatmentA 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 StudyIdiopathic Pulmonary FibrosisDrug: PirfenidoneHoffmann-La RocheNULLCompleted18 YearsN/AAll102Greece
110NCT02759120March 22, 201728/4/2016CleanUP IPF for the Pulmonary Trials CooperativeStudy of Clinical Efficacy of Antimicrobial Therapy Strategy Using Pragmatic Design in Idiopathic Pulmonary FibrosisIdiopathic Pulmonary FibrosisDrug: Antimicrobial therapy: Co-trimoxazole or Doxycycline;Other: No Intervention: Standard of CareWeill Medical College of Cornell UniversityDuke Clinical Research Institute;University of Chicago;University of Washington;University of Pittsburgh;National Heart, Lung, and Blood Institute (NHLBI)Terminated40 YearsN/AAll509Phase 3United States
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
111EUCTR2015-005131-40-CZ20/03/201716/12/2016A 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: 20.0Level: PTClassification code 10021240Term: Idiopathic pulmonary fibrosisSystem 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 LtdNULLNot RecruitingFemale: yes
Male: yes
176Phase 2United Arab Emirates;Greece;Spain;Turkey;Israel;Italy;Egypt;Czech Republic;Hungary;Canada;Belgium;South Africa;Germany;Netherlands
112EUCTR2015-005131-40-HU16/01/201701/12/2016A 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: 19.0Level: PTClassification code 10021240Term: Idiopathic pulmonary fibrosisSystem 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 LtdNULLNot RecruitingFemale: yes
Male: yes
176Phase 2United Arab Emirates;Greece;Spain;Turkey;Israel;Italy;Egypt;Hungary;Czech Republic;Canada;Belgium;South Africa;Netherlands;Germany
113NCT02951429December 31, 201628/10/2016Efficacy, 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 HypertensionA 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 HypertensionIdiopathic Pulmonary FibrosisDrug: Pirfenidone;Drug: Placebo;Drug: SildenafilHoffmann-La RocheNULLCompleted40 Years80 YearsAll177Phase 2Belgium;Canada;Czechia;Egypt;Germany;Greece;Hungary;Israel;Italy;Netherlands;South Africa;Spain;Turkey;Czech Republic;United Arab Emirates
114EUCTR2015-005131-40-BE16/12/201620/10/2016A 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: 21.1Level: PTClassification code 10021240Term: Idiopathic pulmonary fibrosisSystem 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 LtdNULLNot RecruitingFemale: yes
Male: yes
176Phase 2United Arab Emirates;Greece;Spain;Turkey;Israel;Italy;Egypt;Czech Republic;Hungary;Canada;Belgium;South Africa;Germany;Netherlands
115NCT02874989December 16, 201617/8/2016Targeting Pro-Inflammatory Cells in Idiopathic Pulmonary Fibrosis: a Human TrialTargeted Removal of Pro-Inflammatory Cells: An Open Label Human Pilot Study in Idiopathic Pulmonary FibrosisIdiopathic Pulmonary Fibrosis (IPF)Drug: Dasatinib + Quercetin;Drug: PlaceboWake Forest University Health SciencesMayo Clinic;The University of Texas Health Science Center at San AntonioCompleted50 YearsN/AAll26Phase 1United States
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
116EUCTR2015-005131-40-DE08/12/201625/10/2016A 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: 21.1Level: PTClassification code 10021240Term: Idiopathic pulmonary fibrosisSystem 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 LtdNULLNot RecruitingFemale: yes
Male: yes
176Phase 2United Arab Emirates;Greece;Spain;Turkey;Israel;Italy;Egypt;Czech Republic;Hungary;Canada;Belgium;South Africa;Germany;Netherlands
117EUCTR2015-005131-40-GR06/12/201603/11/2016A 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: 19.0Level: PTClassification code 10021240Term: Idiopathic pulmonary fibrosisSystem 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 LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
176Phase 2United Arab Emirates;Greece;Spain;Turkey;Israel;Italy;Egypt;Czech Republic;Hungary;Canada;Belgium;South Africa;Netherlands;Germany
118EUCTR2015-005131-40-NL02/12/201613/10/2016A 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: 20.0Level: PTClassification code 10021240Term: Idiopathic pulmonary fibrosisSystem 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 LtdNULLNot RecruitingFemale: yes
Male: yes
176Phase 2United Arab Emirates;Greece;Spain;Turkey;Israel;Italy;Egypt;Czech Republic;Hungary;Canada;Belgium;South Africa;Netherlands;Germany
119EUCTR2015-003148-38-PL08/11/201604/10/2016Effect of nintedanib on biomarkersA 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: 20.0Level: PTClassification code 10021240Term: Idiopathic pulmonary fibrosisSystem 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 KGNULLNot RecruitingFemale: yes
Male: yes
490Phase 4United States;Finland;Spain;United Kingdom;France;Czech Republic;Hungary;Poland;Belgium;Australia;Germany;Japan;Korea, Republic of
120NCT03050255November 201625/11/2016Short-term Effects of Supplemental Oxygen in Patients With IPFShort-term Effects of Supplemental Oxygen During Walking in Hypoxemic Patients With Idiopathic Pulmonary FibrosisIdiopathic Pulmonary Fibrosis (IPF)Other: Medical air;Other: Oxygen (2Liter/min);Other: Oxygen (4Liter/min)Schön Klinik Berchtesgadener LandLinde AGCompletedN/AN/AAll53N/AGermany
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
121EUCTR2015-005131-40-ES20/10/201609/09/2016A 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: 19.0Level: PTClassification code 10021240Term: Idiopathic pulmonary fibrosisSystem 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 LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
176Phase 2United Arab Emirates;Greece;Spain;Turkey;Israel;Italy;Egypt;Czech Republic;Hungary;Canada;Belgium;South Africa;Germany;Netherlands
122EUCTR2014-004782-24-HU09/08/201614/04/2016A 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: 19.0Level: PTClassification code 10021240Term: Idiopathic pulmonary fibrosisSystem 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.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
117Phase 2United States;Czech Republic;Hungary;Belgium;Spain;Israel;Netherlands;Germany;Italy;United Kingdom;Switzerland
123EUCTR2015-002619-14-GB01/08/201608/09/2016Efficacy and safety of nintedanib when co-administered with sildenafil in IPF patients with advanced lung function impairmentINSTAGE(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]
Boehringer Ingelheim LimitedNULLNot Recruiting Female: yes
Male: yes
300 Human pharmacology (Phase 1): no Therapeut1c exploratory (Phase 2): no Therapeut1c conf1rmatory - (Phase 3): yes Therapeut1c use (Phase 4): noUnited States;Spain;United Kingdom;Italy;India;France;Mexico;Canada;Belgium;Australia;Germany;China;Japan;Korea, Republic of
124NCT02885961August 201615/8/2016The Coagulation Cascade in Idiopathic Pulmonary FibrosisInvestigating the Role of the Coagulation Cascade in Idiopathic Pulmonary FibrosisIdiopathic Pulmonary Fibrosis;IPF;Interstitial Lung DiseaseDrug: Dabigatran;Radiation: FDG PET scanUniversity College, LondonNULLNot yet recruiting40 Years80 YearsBoth12N/ANULL
125EUCTR2015-002619-14-BE25/07/201603/06/2016Efficacy and safety of nintedanib when co-administered with sildenafil in IPF patients with advanced lung function impairmentINSTAGE (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: 20.0Level: PTClassification code 10021240Term: Idiopathic pulmonary fibrosisSystem 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. VNULLNot RecruitingFemale: yes
Male: yes
300Phase 3United States;Spain;United Kingdom;Italy;India;France;Mexico;Canada;Belgium;Australia;Germany;China;Japan;Korea, Republic of
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
126EUCTR2015-002619-14-DE21/07/201604/05/2016Efficacy and safety of nintedanib when co-administered with sildenafil in IPF patients with advanced lung function impairmentINSTAGE(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: 19.0Level: PTClassification code 10021240Term: Idiopathic pulmonary fibrosisSystem 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. KGNULLNot RecruitingFemale: yes
Male: yes
300Phase 3United States;Spain;United Kingdom;Italy;India;France;Mexico;Canada;Belgium;Australia;Germany;China;Japan;Korea, Republic of
127EUCTR2015-003148-38-DE14/07/201620/05/2016Effect of nintedanib on biomarkersA 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]
Boehringer Ingelheim Pharma GmbH & Co. KGNULLNot Recruiting Female: yes
Male: yes
490 Human pharmacology (Phase 1): no Therapeut1c exploratory (Phase 2): no Therapeut1c conf1rmatory - (Phase 3): no Therapeut1c use (Phase 4): yesUnited States;Finland;Spain;United Kingdom;France;Czech Republic;Hungary;Belgium;Poland;Australia;Germany;Japan;Korea, Republic of
128NCT02802345June 30, 201614/6/2016Efficacy and Safety of Nintedanib Co-administered With Sildenafil in Idiopathic Pulmonary Fibrosis Patients With Advanced Lung Function ImpairmentINSTAGE: 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 ImpairmentIdiopathic Pulmonary FibrosisDrug: Nintedanib;Drug: Placebo;Drug: SildenafilBoehringer IngelheimNULLCompleted40 YearsN/AAll274Phase 3United States;Australia;Belgium;Canada;France;Germany;India;Italy;Japan;Korea, Republic of;Mexico;Spain;United Kingdom
129EUCTR2015-002619-14-ES29/06/201617/05/2016Efficacy and safety of nintedanib when co-administered with sildenafil in IPF patients with advanced lung function impairmentA 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: 19.0Level: PTClassification code 10021240Term: Idiopathic pulmonary fibrosisSystem 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.NULLNot RecruitingFemale: yes
Male: yes
300Phase 3United States;Spain;United Kingdom;Italy;India;France;Mexico;Canada;Belgium;Australia;Germany;China;Japan;Korea, Republic of
130EUCTR2015-003148-38-ES13/06/201611/03/2016Effect of nintedanib on biomarkersA 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: 18.1Level: PTClassification code 10021240Term: Idiopathic pulmonary fibrosisSystem 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.NULLNot RecruitingFemale: yes
Male: yes
490Phase 4United States;Finland;Spain;United Kingdom;France;Czech Republic;Hungary;Belgium;Poland;Australia;Germany;Japan;Korea, Republic of
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
131NCT02788474June 9, 201627/5/2016Effect of Nintedanib on Biomarkers of Extracellular Matrix Turnover in Patients With Idiopathic Pulmonary Fibrosis and Limited Forced Vital Capacity ImpairmentA 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 FibrosisDrug: nintedanib;Drug: placeboBoehringer IngelheimNULLCompleted40 YearsN/AAll347Phase 4United States;Australia;Belgium;Czechia;Finland;France;Germany;Hungary;Japan;Korea, Republic of;Poland;Spain;United Kingdom;Czech Republic
132EUCTR2015-003148-38-GB06/06/201618/04/2016Effect of nintedanib on biomarkersA 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]
Boehringer Ingelheim LimitedNULLNot Recruiting Female: yes
Male: yes
490 Human pharmacology (Phase 1): no Therapeut1c exploratory (Phase 2): no Therapeut1c conf1rmatory - (Phase 3): no Therapeut1c use (Phase 4): yesUnited States;Finland;Spain;United Kingdom;France;Czech Republic;Hungary;Belgium;Poland;Australia;Germany;Japan;Korea, Republic of
133EUCTR2015-003148-38-BE06/06/201619/04/2016Effect of nintedanib on biomarkersA 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: 20.0Level: PTClassification code 10021240Term: Idiopathic pulmonary fibrosisSystem 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. VNULLNot RecruitingFemale: yes
Male: yes
490Phase 4United States;Finland;Spain;United Kingdom;France;Czech Republic;Hungary;Belgium;Poland;Australia;Germany;Japan;Korea, Republic of
134NCT02688647June 201618/2/2016A Study to Evaluate the Safety, Tolerability, and Activity of KD025 in Subjects With Idiopathic Pulmonary FibrosisA Randomized, Phase 2, Open-Label, Multicenter Study to Evaluate the Safety, Tolerability, and Activity of KD025 in Subjects With Idiopathic Pulmonary Fibrosis (IPF)Idiopathic Pulmonary FibrosisDrug: KD025;Drug: Standard of CareKadmon Corporation, LLCNULLActive, not recruiting18 YearsN/AAll76Phase 2United States
135NCT02846324June 20167/7/2016Study to Evaluate the Safety and Tolerability of GBT440 Administered to Subjects With IPFA 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;HypoxemiaDrug: GBT440;Drug: PlaceboGlobal Blood TherapeuticsNULLCompleted45 Years80 YearsAll39Phase 2United States
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
136EUCTR2015-003148-38-HU27/05/201612/04/2016Effect of nintedanib on biomarkersA 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: 18.1Level: PTClassification code 10021240Term: Idiopathic pulmonary fibrosisSystem 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 KGNULLNot RecruitingFemale: yes
Male: yes
490Phase 4United States;Finland;Spain;United Kingdom;France;Hungary;Czech Republic;Belgium;Poland;Australia;Germany;Japan;Korea, Republic of
137EUCTR2015-003148-38-CZ26/05/201611/04/2016Effect of nintedanib on biomarkersA 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: 18.1Level: PTClassification code 10021240Term: Idiopathic pulmonary fibrosisSystem 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 KGNULLNot RecruitingFemale: yes
Male: yes
490Phase 4Finland;Spain;United Kingdom;France;Czech Republic;Hungary;Belgium;Poland;Australia;Germany;Japan;Korea, Republic of;United States
138EUCTR2015-003148-38-FR24/05/201604/05/2016Effect of nintedanib on biomarkersA 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: 19.0Level: PTClassification code 10021240Term: Idiopathic pulmonary fibrosisSystem 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 FranceNULLNot RecruitingFemale: yes
Male: yes
490Phase 4United States;Finland;Spain;United Kingdom;France;Czech Republic;Hungary;Belgium;Poland;Australia;Germany;Japan;Korea, Republic of
139EUCTR2015-003148-38-FI17/05/201612/04/2016Effect of nintedanib on biomarkersA 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: 19.0Level: PTClassification code 10021240Term: Idiopathic pulmonary fibrosisSystem 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 KyNULLNot RecruitingFemale: yes
Male: yes
490Phase 4United States;Finland;Spain;United Kingdom;France;Czech Republic;Hungary;Belgium;Poland;Australia;Germany;Japan;Korea, Republic of
140JPRN-JapicCTI-16332601/5/201622/07/2016Phase III clinical study of ART-123 for the treatment of acute exacerbation of idiopathic pulmonary fibrosisPhase 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 CORPORATIONNULLrecruiting4085BOTHPhase 3NULL
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
141NCT02739165May 20161/4/2016Clinical Study of ART-123 for the Treatment of Acute Exacerbation of Idiopathic Pulmonary FibrosisPhase 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-123Idiopathic Pulmonary FibrosisDrug: ART-123;Drug: PlaceboAsahi Kasei Pharma CorporationNULLCompleted40 Years85 YearsAll74Phase 3Japan
142EUCTR2015-003280-11-NL29/04/201619/01/2016A Study of the Safety and Tolerability of Pirfenidone (Esbriet) in Combination with Nintedanib (Ofev) in Patients with Idiopathic Pulmonary FibrosisAN 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: 19.0Level: PTClassification code 10021240Term: Idiopathic pulmonary fibrosisSystem 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 LtdNULLNot RecruitingFemale: yes
Male: yes
80Phase 4France;United States;Canada;Spain;Denmark;Germany;Netherlands;Italy
143EUCTR2014-004782-24-CZ25/04/201611/08/2015A 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]
Promedior, Inc.NULLNot Recruiting Female: yes
Male: yes
117 Human pharmacology (Phase 1): no Therapeut1c exploratory (Phase 2): yes Therapeut1c conf1rmatory - (Phase 3): no Therapeut1c use (Phase 4): noFrance;United States;Hungary;Czech Republic;Spain;Belgium;Netherlands;Germany;United Kingdom
144JPRN-UMIN0000220372016/04/1924/04/2016The pilot study of nivolumab for advanced NSCLC patients with IIPs which is clinically considered to be at low risk of acute exacerbation of IIPs. Advanced NSCLC patients with IIPsNivolumab 3mg/kg, every 2 weeksKobe city medical center general hospitalNULLComplete: follow-up complete20years-old100years-oldMale and Female6Not selectedJapan
145NCT02606877April 19, 201616/11/2015A Study to Compare the Amount of Nintedanib and Pirfenidone in the Blood When Nintedanib and Pirfenidone Are Given Separately or in CombinationInvestigation of Drug-drug Interaction Between Nintedanib and Pirfenidone in Patients With IPF (an Open Label, Multiple-dose, Two Group Study)Idiopathic Pulmonary FibrosisDrug: nintedanib;Drug: pirfenidoneBoehringer IngelheimNULLCompleted40 YearsN/AAll37Phase 4United Kingdom
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
146EUCTR2014-004782-24-ES31/03/201615/12/2015A 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]
Promedior, Inc.NULLNot Recruiting Female: yes
Male: yes
117 Human pharmacology (Phase 1): no Therapeut1c exploratory (Phase 2): yes Therapeut1c conf1rmatory - (Phase 3): no Therapeut1c use (Phase 4): noUnited States;Hungary;Czech Republic;Belgium;Spain;Netherlands;Germany;United Kingdom
147EUCTR2015-004157-41-GB21/03/201602/12/2015Randomized, 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]
Galapagos NVNULLNot Recruiting Female: yes
Male: yes
24 Human pharmacology (Phase 1): no Therapeut1c exploratory (Phase 2): yes Therapeut1c conf1rmatory - (Phase 3): no Therapeut1c use (Phase 4): noUkraine;United Kingdom
148EUCTR2014-004782-24-DE01/03/201619/05/2015A 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: 18.1Level: PTClassification code 10021240Term: Idiopathic pulmonary fibrosisSystem 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.NULLNot RecruitingFemale: yes
Male: yes
117Phase 2United States;Hungary;Czech Republic;Belgium;Spain;Israel;Netherlands;Germany;Italy;United Kingdom;Switzerland
149NCT02738801March 201611/4/2016Study 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 FibrosisDrug: GLPG1690 600 mg QD;Drug: Placebo QDGalapagos NVNULLCompleted40 YearsN/AAll23Phase 2Ukraine;United Kingdom;Italy
150EUCTR2015-003280-11-DE25/02/201619/10/2015A Study of the Safety and Tolerability of Pirfenidone (Esbriet) in Combination with Nintedanib (Ofev) in Patients with Idiopathic Pulmonary FibrosisAN 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: 19.0Level: PTClassification code 10021240Term: Idiopathic pulmonary fibrosisSystem 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 LtdNULLNot RecruitingFemale: yes
Male: yes
80Phase 4France;United States;Canada;Spain;Denmark;Netherlands;Germany;Italy
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
151EUCTR2014-005658-20-BG23/02/201618/12/2015FG-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: 19.1Level: PTClassification code 10021240Term: Idiopathic pulmonary fibrosisSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
MedDRA version: 19.1Level: SOCClassification code 10038738Term: Respiratory, thoracic and mediastinal disordersSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
MedDRA version: 19.1Level: HLTClassification code 10033979Term: Parenchymal lung disorders NECSystem 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.NULLNot RecruitingFemale: yes
Male: yes
136Phase 2United States;Canada;Australia;South Africa;Bulgaria;New Zealand;India
152EUCTR2014-003933-24-PT15/02/201607/10/2015Efficacy and Safety of SAR156597 in the Treatment of Idiopathic Pulmonary FibrosisEfficacy 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]
sanofi-aventis recherche & développementNULLNot Recruiting Female: yes
Male: yes
300 Human pharmacology (Phase 1): no Therapeut1c exploratory (Phase 2): yes Therapeut1c conf1rmatory - (Phase 3): no Therapeut1c use (Phase 4): noPortugal;United States;Greece;Spain;Turkey;Israel;Chile;Colombia;Italy;United Kingdom;France;Czech Republic;Mexico;Canada;Argentina;Australia;Denmark;Germany;Korea, Republic of
153JPRN-UMIN0000207222016/01/2625/01/2016Prospective study of efficiency of fibrosis score in computed tomography as predictor after treatment with Nintedanib for idiopathic pulmonary fibrosis idiopathic pulmonary fibrosisadministration of 150mg of nintedanib twice dailyKanagawa Cardiovascular and Respiratory CenterNULLRecruiting40years-oldNot applicableMale and Female30Not appl1cableJapan
154JPRN-UMIN0000206822016/01/2222/01/2016The comparison of the efficacy and safety of pirfenidone and nintedanib in patients with idiopathic pulmonary fibrosis Idiopathic pulmonary fibrosispirfenidone 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 DisabilitiesNULLPending20years-oldNot applicableMale and Female60Not appl1cableJapan
155EUCTR2015-003280-11-DK20/01/201625/11/2015A Study of the Safety and Tolerability of Pirfenidone (Esbriet) in Combination with Nintedanib (Ofev) in Patients with Idiopathic Pulmonary FibrosisAN 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: 19.0Level: PTClassification code 10021240Term: Idiopathic pulmonary fibrosisSystem 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 LtdNULLNot RecruitingFemale: yes
Male: yes
80Phase 4France;United States;Canada;Spain;Denmark;Netherlands;Germany;Italy
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
156NCT02648048January 15, 20165/1/2016A Study of Oral Vismodegib in Combination With Pirfenidone in Participants With Idiopathic Pulmonary FibrosisA 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 FibrosisIdiopathic Pulmonary FibrosisDrug: Pirfenidone;Drug: VismodegibHoffmann-La RocheNULLCompleted40 Years80 YearsAll21Phase 1United States;Germany
157NCT02598193January 14, 20164/11/2015Safety 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 FibrosisIdiopathic Pulmonary FibrosisDrug: Nintedanib;Drug: PirfenidoneHoffmann-La RocheNULLCompleted40 Years80 YearsAll89Phase 4United States;Canada;Denmark;France;Germany;Italy;Netherlands;Spain
158EUCTR2015-000640-42-IT22/12/201522/02/2018Safety, tolerability and PK of nintedanib in combination with pirfenidone in IPFA 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: 20.0Level: PTClassification code 10021240Term: Idiopathic pulmonary fibrosisSystem 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.NULLNot RecruitingFemale: yes
Male: yes
135Phase 4France;United States;Canada;Netherlands;Germany;Italy
159EUCTR2015-003280-11-ES16/12/201530/10/2015A Study of the Safety and Tolerability of Pirfenidone (Esbriet) in Combination with Nintedanib (Ofev) in Patients with Idiopathic Pulmonary FibrosisAN 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: 18.1Level: PTClassification code 10021240Term: Idiopathic pulmonary fibrosisSystem 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 LtdNULLNot RecruitingFemale: yes
Male: yes
80Phase 4France;United States;Canada;Spain;Denmark;Netherlands;Germany;Italy
160NCT02612051December 4, 201519/11/2015First Time in Human (FTIH) Study of GSK3008348 in Healthy Volunteers and Idiopathic Pulmonary Fibrosis PatientsA FTIH Study With GSK3008348 in Healthy Volunteers and Patients With Idiopathic Pulmonary FibrosisIdiopathic Pulmonary FibrosisDrug: GSK3008348 Nebuliser solution;Drug: Placebo Nebuliser solution;Radiation: GSK26346763: ([18F]-FBA-A20FMDV2) IV infusionGlaxoSmithKlineNULLCompleted18 YearsN/AAll40Phase 1United Kingdom
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
161EUCTR2014-000861-32-DE01/12/201502/09/2015Standard-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: 20.0Level: LLTClassification code 10022612Term: Interstitial lung fibrosisSystem Organ Class: 100000004855
MedDRA version: 20.0Level: LLTClassification code 10035754Term: Pneumonitis hypersensitivitySystem Organ Class: 100000004855
MedDRA version: 20.0Level: LLTClassification code 10025088Term: Lung fibrosisSystem Organ Class: 100000004855
MedDRA version: 20.0Level: LLTClassification code 10022617Term: Interstitial pneumoniaSystem 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 GiessenNULLNot RecruitingFemale: yes
Male: yes
374Phase 2Germany
162EUCTR2015-000640-42-DE01/12/201503/09/2015Safety, tolerability and PK of nintedanib in combination with pirfenidone in IPFA 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: 19.0Level: PTClassification code 10021240Term: Idiopathic pulmonary fibrosisSystem 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.KGNULLNot RecruitingFemale: yes
Male: yes
135Phase 4France;United States;Canada;Netherlands;Germany;Italy
163NCT02551068December 20151/9/2015High Oxygen Delivery to Preserve Exercise Capacity in Idiopathic Pulmonary Fibrosis Patients Treated With NintedanibHigh Oxygen Delivery to Preserve Exercise Capacity in IPF Patients Treated With Nintedanib: The HOPE-IPF StudyIdiopathic Pulmonary FibrosisOther: 60% Oxygen;Other: Standard of CareUniversity of British ColumbiaBoehringer IngelheimRecruiting19 YearsN/AAll88N/ACanada
164NCT02460588December 201516/3/2015Cyclophosphamide for Acute Exacerbation of Idiopathic Pulmonary FibrosisCyclophosphamide Added to Corticosteroid in the Treatment of Acute Exacerbation of Idiopathic Pulmonary Fibrosis: a Placebo-controlled Randomized TrialIdiopathic Pulmonary FibrosisDrug: Cyclophosphamide;Drug: Placebo;Drug: Corticosteroid (prednisolone)Assistance Publique - Hôpitaux de ParisNULLCompleted18 YearsN/AAll120Phase 3France
165EUCTR2015-000492-27-FR24/11/201511/09/2015N/AN/A - EXAFIP
MedDRA version: 18.0Level: LLTClassification code 10067761Term: Exacerbation of idiopathic pulmonary fibrosisSystem 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)NULLNot RecruitingFemale: yes
Male: yes
120Phase 3France
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
166EUCTR2014-004782-24-BE06/11/201527/05/2015A 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]
Promedior, Inc.NULLNot Recruiting Female: yes
Male: yes
117 Human pharmacology (Phase 1): no Therapeut1c exploratory (Phase 2): yes Therapeut1c conf1rmatory - (Phase 3): no Therapeut1c use (Phase 4): noUnited States;Hungary;Czech Republic;Spain;Belgium;Israel;Netherlands;Germany;Italy;United Kingdom;Switzerland
167JPRN-UMIN0000194362015/10/1621/10/2015Randomized 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 fibrosisNintedanib+pirfenidone group;
Nintedanib 150mg twice daily
Pirfenidone 600-1800mg/day
Nintedanib group;
Nintedanib 150mg twice daily
Kanagawa Cardiovascular and Respiratory CenterNULLComplete: follow-up complete40years-oldNot applicableMale and Female60Phase 2Japan
168NCT02579603October 16, 201516/10/2015Safety, Tolerability and PK of Nintedanib in Combination With Pirfenidone in IPFA 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 FibrosisDrug: Nintedanib;Drug: PirfenidoneBoehringer IngelheimNULLCompleted40 YearsN/AAll105Phase 4United States;Canada;France;Germany;Italy;Netherlands
169EUCTR2015-000640-42-NL13/10/201518/08/2015Safety, tolerability and PK of nintedanib in combination with pirfenidone in IPFA 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: 18.1Level: PTClassification code 10021240Term: Idiopathic pulmonary fibrosisSystem 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 bvNULLNot RecruitingFemale: yes
Male: yes
135Phase 4France;United States;Canada;Germany;Netherlands;Italy
170NCT02550873September 7, 201527/8/2015A 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 FibrosisBiological: PRM-151;Other: placeboHoffmann-La RocheNULLCompleted40 Years80 YearsAll117Phase 2United States;Czechia;Germany;Italy;Netherlands;Spain;Switzerland;Belgium;Czech Republic;Israel;United Kingdom
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
171EUCTR2014-003933-24-DE31/08/201502/03/2015Efficacy and Safety of SAR156597 in the Treatment of Idiopathic Pulmonary FibrosisEfficacy 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: 19.0Level: PTClassification code 10021240Term: Idiopathic pulmonary fibrosisSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Code: SAR156597sanofi-aventis recherche & développementNULLNot RecruitingFemale: yes
Male: yes
300Phase 2Portugal;United States;Greece;Spain;Turkey;Israel;Chile;Colombia;Italy;United Kingdom;France;Czech Republic;Mexico;Canada;Argentina;Australia;Denmark;Germany;Korea, Republic of
172EUCTR2015-000640-42-FR26/08/201505/08/2015Safety, tolerability and PK of nintedanib in combination with pirfenidone in IPFA 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: 18.0Level: PTClassification code 10021240Term: Idiopathic pulmonary fibrosisSystem 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 FranceNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
135United States;France;Canada;Netherlands;Germany;Italy
173NCT02502097August 26, 201516/7/2015A 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 CoughIdiopathic Pulmonary Fibrosis;CoughDrug: Gefapixant;Other: PlaceboAfferent Pharmaceuticals, Inc.NULLCompleted40 YearsN/AAll51Phase 2United States
174EUCTR2014-003933-24-GB29/07/201505/02/2015Efficacy and Safety of SAR156597 in the Treatment of Idiopathic Pulmonary FibrosisEfficacy 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]
sanofi-aventis recherche & développementNULLNot Recruiting Female: yes
Male: yes
300 Human pharmacology (Phase 1): no Therapeut1c exploratory (Phase 2): yes Therapeut1c conf1rmatory - (Phase 3): no Therapeut1c use (Phase 4): noPortugal;United States;Greece;Spain;Turkey;Israel;Chile;Colombia;Italy;United Kingdom;France;Czech Republic;Mexico;Canada;Argentina;Australia;Denmark;Germany;Korea, Republic of
175NCT02477709July 20, 201517/6/2015A 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 FibrosisDrug: GefapixantAfferent Pharmaceuticals, Inc.NULLCompleted40 YearsN/AAll6Phase 2United States
No.TrialIDDate_
enrollment
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Public_titleScientific_titleConditionInterventionPrimary_
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176NCT02538536July 201525/8/2015A 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: PBI4050Liminal BioSciences Ltd.NULLCompleted40 YearsN/AAll41Phase 2Canada
177NCT01841307July 201523/4/2013Cromolyn Detection of Silent AspirationDevelopment and Validation of Test for Gastro-esophageal Reflux and AspirationGastroesophageal Reflux;Respiratory Aspiration;Idiopathic Pulmonary Fibrosis;Lung TransplantationDrug: Cromolyn SodiumUniversity of California, San FranciscoAradign Corportation;National Heart, Lung, and Blood Institute (NHLBI)Terminated18 Years70 YearsAll16Phase 1United States
178EUCTR2014-003933-24-GR14/05/201522/06/2015Efficacy and Safety of SAR156597 in the Treatment of Idiopathic Pulmonary FibrosisEfficacy 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: 18.0Level: PTClassification code 10021240Term: Idiopathic pulmonary fibrosisSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Code: SAR156597sanofi-aventis recherche & développementNULLNot RecruitingFemale: yes
Male: yes
300Phase 2Portugal;United States;Greece;Spain;Turkey;Israel;Chile;Colombia;Italy;United Kingdom;France;Czech Republic;Mexico;Canada;Argentina;Denmark;Germany;Korea, Republic of
179EUCTR2014-003933-24-FR12/05/201503/06/2015Efficacy and Safety of SAR156597 in the Treatment of Idiopathic Pulmonary FibrosisEfficacy 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: 18.0Level: PTClassification code 10021240Term: Idiopathic pulmonary fibrosisSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Code: SAR156597sanofi-aventis recherche & développementNULLNot RecruitingFemale: yes
Male: yes
300Phase 2Portugal;United States;Greece;Spain;Turkey;Chile;Israel;Colombia;United Kingdom;Italy;France;Czech Republic;Mexico;Canada;Argentina;Denmark;Germany;Korea, Republic of
180EUCTR2014-004782-24-NL06/05/201508/12/2014A 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: 17.1Level: PTClassification code 10021240Term: Idiopathic pulmonary fibrosisSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Body processes [G] - Circulatory and Respiratory Physiological Phenomena [G09]
Product Code: PRM-151Promedior incNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
60Netherlands
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
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PhaseCountries
181NCT02345070May 1, 201519/1/2015Efficacy and Safety of SAR156597 in the Treatment of Idiopathic Pulmonary FibrosisEfficacy and Safety of SAR156597 in the Treatment of Idiopathic Pulmonary Fibrosis (IPF): A Randomized, Double-blind, Placebo-controlled, 52-week Dose-ranging StudyIdiopathic Pulmonary FibrosisDrug: SAR156597;Drug: placeboSanofiNULLCompleted40 YearsN/AAll327Phase 2United States;Argentina;Australia;Canada;Chile;Colombia;Czechia;Denmark;France;Germany;Greece;Israel;Italy;Korea, Republic of;Mexico;Portugal;Spain;Turkey;United Kingdom;Czech Republic
182NCT02267655May 20157/10/20143 Part Study to Assess Inhaled Nitric Oxide on Functional Pulmonary Imaging in Subj. Pulmonary Hypertension Associated w/ COPD and IPFAn 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 FibrosisDrug: 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/hrBellerophonNULLCompleted40 Years80 YearsAll8Phase 1Belgium
183NCT02478268May 201516/6/2015Using MRI to Visualize Regional Therapy Response in Idiopathic Pulmonary FibrosisUsing MRI to Visualize Regional Therapy Response in Idiopathic Pulmonary FibrosisIdiopathic Pulmonary FibrosisDrug: Hyperpolarized 129-Xenon gas;Device: MRIBastiaan DriehuysUniversity of Wisconsin, Madison;National Heart, Lung, and Blood Institute (NHLBI)Completed18 YearsN/AAll64Phase 1United States
184EUCTR2014-003933-24-ES30/04/201503/03/2015Efficacy and Safety of SAR156597 in the Treatment of Idiopathic Pulmonary FibrosisEfficacy 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: 18.0Level: PTClassification code 10021240Term: Idiopathic pulmonary fibrosisSystem 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 & développementNULLNot RecruitingFemale: yes
Male: yes
300Phase 2United Kingdom;France;Czech Republic;Mexico;Canada;Argentina;Denmark;Germany;Korea, Republic of;Portugal;United States;Greece;Spain;Turkey;Israel;Chile;Colombia;Italy
185EUCTR2014-003933-24-CZ10/04/201513/02/2015Efficacy and Safety of SAR156597 in the Treatment of Idiopathic Pulmonary FibrosisEfficacy 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: 18.0Level: PTClassification code 10021240Term: Idiopathic pulmonary fibrosisSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Code: SAR156597sanofi-aventis recherche & développementNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
300United States;Portugal;Greece;Spain;Turkey;Chile;Israel;Colombia;United Kingdom;Italy;France;Czech Republic;Mexico;Canada;Argentina;Australia;Denmark;Germany;Korea, Republic of
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
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sponsor
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agemin
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PhaseCountries
186EUCTR2014-003933-24-DK07/04/201520/02/2015Efficacy and Safety of SAR156597 in the Treatment of Idiopathic Pulmonary FibrosisEfficacy 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: 18.0Level: PTClassification code 10021240Term: Idiopathic pulmonary fibrosisSystem 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 & développementNULLNot RecruitingFemale: yes
Male: yes
300Phase 2Portugal;United States;Greece;Spain;Turkey;Israel;Chile;Colombia;Italy;United Kingdom;France;Czech Republic;Mexico;Canada;Argentina;Denmark;Australia;Germany;Korea, Republic of
187JPRN-UMIN0000168262015/03/3131/03/2015The 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 HospitalNULLComplete: follow-up completeNot applicableNot applicableMale and Female40Not appl1cableJapan
188EUCTR2014-004025-40-NL06/02/201511/12/2014Treatment 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: 18.0Level: LLTClassification code 10066656Term: Chronic coughSystem 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 PharmaNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
48Netherlands;United Kingdom
189NCT02412020February 20153/4/2015Treatment of Refractory Chronic Cough With PA101Treatment of Chronic Idiopathic Cough and Chronic Cough in Patients With Idiopathic Pulmonary Fibrosis With PA101Refractory Chronic CoughDrug: PA101;Drug: PlaceboPatara PharmaNULLCompleted18 Years75 YearsBoth52Phase 2Netherlands;United Kingdom
190JPRN-UMIN0000155082015/01/0124/10/2014A 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 fibrosisUsing 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.NULLComplete: follow-up complete40years-oldNot applicableMale and Female150Not selectedJapan
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
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agemin
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191ChiCTR-OOC-150058412015-01-012015-01-17Montelukast Sodium Tablets treatment clinical study for intractable cough by idiopathic pulmonary fibrosisMontelukast Sodium Tablets treatment clinical study for intractable cough by idiopathic pulmonary fibrosis Idiopathic pulmonary fibrosisMontelukast 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 HospitalNULLRecruiting5080BothMontelukast Sodium Tablets treatment group :30;control group :30;NULL
192ChiCTR-OOC-150058622015-01-012015-01-19The 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 fibrosistreatment group:subcutaneous injection of Granulocyte colony stimulating factor termly;control group:no processing;Shanghai Pulmonary HospitalNULLRecruiting5080Bothtreatment group:50;control group:50;China
193NCT02485886January 201526/6/201568Ga-BMV101 PET/CT in Patients With Idiopathic Pulmonary FibrosisSafety and Diagnostic Performance of 68Ga-BMV101 PET/CT in Patients With Idiopathic Pulmonary FibrosisIdiopathic Pulmonary FibrosisDrug: 68Ga-BMV101Peking Union Medical College HospitalStanford UniversityUnknown status18 YearsN/AAll20Early Phase 1China
194EUCTR2014-004058-32-GB19/12/201412/06/2015Treating pulmonary fibrosis with co-trimoxazoleThe 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: 18.0Level: PTClassification code 10021240Term: Idiopathic pulmonary fibrosisSystem 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 TrustNULLNot RecruitingFemale: yes
Male: yes
330Phase 3United Kingdom
195EUCTR2014-004025-40-GB09/12/201406/01/2015Treatment 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]
Patara PharmaNULLNot Recruiting Female: yes
Male: yes
48 Human pharmacology (Phase 1): no Therapeut1c exploratory (Phase 2): yes Therapeut1c conf1rmatory - (Phase 3): no Therapeut1c use (Phase 4): noNetherlands;United Kingdom
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
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agemin
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PhaseCountries
196JPRN-JapicCTI-14270824/10/201414/11/2014A phase II study of LebrikizumabA PHASE II, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, STUDY TO ASSESS THE EFFICACY AND SAFETY OF LEBRIKIZUMAB IN PATIENTS WITH IDIOPATHIC PULMONARY IDIOPATHIC PULMONARY FIBROSISIntervention 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.NULL40BOTH480Phase 2NULL
197NCT04016168October 22, 20148/7/2019Idiopathic Pulmonary Fibrosis and Serum BankIdiopathic Pulmonary Fibrosis and Serum BankIdiopathic Pulmonary Fibrosis;Lung Diseases, InterstitialBiological: Blood sample collectionRennes University HospitalNULLRecruiting18 YearsN/AAll500France
198EUCTR2014-000963-42-DE01/10/201413/08/2014A phase II study to assess vismodegib in the treatment of idiopathic pulmonary fibrosisA 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: 17.0Level: PTClassification code 10021240Term: Idiopathic pulmonary fibrosisSystem 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.NULLNot RecruitingFemale: yes
Male: yes
129Phase 2United States;France;Mexico;Spain;Peru;Australia;Israel;Chile;Germany;New Zealand;Italy;Korea, Republic of
199EUCTR2014-003423-21-BE29/09/201429/08/2014Evaluation 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: 18.1Level: PTClassification code 10021240Term: Idiopathic pulmonary fibrosisSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
MedDRA version: 18.1Level: LLTClassification code 10010952Term: COPDSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
MedDRA version: 18.1Level: PTClassification code 10009033Term: Chronic obstructive pulmonary diseaseSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
MedDRA version: 18.1Level: PTClassification code 10037400Term: Pulmonary hypertensionSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
MedDRA version: 18.1Level: HLTClassification code 10037401Term: Pulmonary hypertensionsSystem 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 LLCNULLNot RecruitingFemale: yes
Male: yes
Phase 1;Phase 2Belgium
200NCT02257177September 201429/9/2014RCT (Randomized Control Trial) of TD139 vs Placebo in HV's (Human Volunteers) and IPF PatientsA 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 FibrosisDrug: Inhaled TD139;Drug: PlaceboGalecto Biotech ABNULLCompleted45 Years85 YearsAll60Phase 1/Phase 2United Kingdom
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
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201NCT02268981September 201417/9/2014Effects of an Oxymizer® During Daytime in Patients With Pulmonary Fibrosis (IPF)Effects of an Oxymizer® During Daytime in Patients With Pulmonary Fibrosis (IPF)Idiopathic Pulmonary FibrosisDevice: Oxymizer® compared to CNCKlinikum Berchtesgadener Land der Schön-KlinikenNULLCompleted30 Years80 YearsBoth18N/AGermany
202NCT02173145August 19, 201423/6/2014Azithromycin in Idiopathic Pulmonary FibrosisAzithromycin for the Treatment of Cough in Idiopathic Pulmonary Fibrosis- a Clinical TrialIdiopathic Pulmonary Fibrosis;CoughDrug: azithromycin;Drug: placeboUniversity Hospital Inselspital, BerneUniversity of BernCompleted18 YearsN/AAll27N/ASwitzerland
203NCT02135380August 20148/5/2014Evaluate Safety and Efficacy of Intravenous Autologous ADMSc for Treatment of Idiopathic Pulmonary FibrosisA 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 FibrosisBiological: Autologous Stromal Vascular Fraction (SVF);Biological: Autologous Adipose Derived MSCs (ADMSCs);Other: ControlKasiak Research Pvt. Ltd.NULLRecruiting30 Years70 YearsBoth60Phase 1/Phase 2India
204NCT02248064July 201412/9/2014Auto-titrating Oxygen in Chronic Respiratory FailureThe Assessment of Intelligent Oxygen Therapy (iO2t) in Patients With Chronic Obstructive Pulmonary Disease (COPD) and Idiopathic Pulmonary Fibrosis (IPF)Chronic Obstructive Pulmonary Disease;Idiopathic Pulmonary FibrosisDevice: Auto-titrating oxygen systemImperial College LondonNULLCompleted18 YearsN/ABoth26N/AUnited Kingdom
205NCT02622477June 20142/12/2015Clinical 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 IPFIdiopathic Pulmonary FibrosisDrug: PirfenidoneHoffmann-La RocheInterMune Deutschland GmbHCompletedN/AN/AAll12N/AGermany
No.TrialIDDate_
enrollment
Date_
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Public_titleScientific_titleConditionInterventionPrimary_
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206EUCTR2013-004404-19-GB07/05/201425/03/2014Effect of Fostair® on biomarkers of platelet adhesion in Idiopathic pulmonary fibrosisA 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: 16.1Level: PTClassification code 10021240Term: Idiopathic pulmonary fibrosisSystem 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 TrustNULLNot RecruitingFemale: yes
Male: yes
United Kingdom
207NCT02036970May 201413/1/2014Bardoxolone Methyl Evaluation in Patients With Pulmonary Hypertension (PH) - LARIATA Dose-Ranging Study of the Efficacy and Safety of Bardoxolone Methyl in Patients With Pulmonary HypertensionPulmonary 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 FibroelastosisDrug: Bardoxolone methyl;Drug: PlaceboReata Pharmaceuticals, Inc.NULLCompleted18 Years75 YearsAll166Phase 2United States;Germany;Spain;United Kingdom
208EUCTR2013-001163-24-BE28/04/201410/02/2014A 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 LtdNULLNot RecruitingFemale: yes
Male: yes
480Phase 2United States;Spain;United Kingdom;Italy;France;Mexico;Canada;Belgium;Poland;Australia;Peru;Germany;Japan
209NCT02085018March 28, 20149/2/2014Pilot Trial Of Omeprazole in Idiopathic Pulmonary Fibrosis (IPF)A Randomised, Placebo-controlled Trial of Omeprazole in Idiopathic Pulmonary Fibrosis (IPF)Idiopathic Pulmonary FibrosisDrug: Omeprazole;Drug: Matched placeboNewcastle-upon-Tyne Hospitals NHS TrustNewcastle UniversityCompleted40 Years85 YearsAll45Phase 2United Kingdom
210NCT02048644March 201423/1/2014Effect of Fostair® on Biomarkers of Platelet Adhesion in Idiopathic Pulmonary FibrosisA 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 FibrosisIdiopathic Pulmonary FibrosisDrug: fostair;Drug: placeboHull University Teaching Hospitals NHS TrustChiesi Farmaceutici S.p.A.Completed40 Years85 YearsAll20Phase 2United Kingdom
No.TrialIDDate_
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PhaseCountries
211NCT02055456February 20143/2/2014Nandrolone Decanoate in the Treatment of TelomeropathiesMale Hormones for Telomere Related DiseasesAplastic Anemia;Bone Marrow Failure Syndromes;Idiopathic Pulmonary Fibrosis;Telomere ShorteningDrug: Nandrolone DecanoateUniversity of Sao PauloConselho Nacional de Desenvolvimento Científico e TecnológicoRecruiting2 YearsN/ABoth20Phase 1/Phase 2Brazil
212NCT02036580January 201413/1/2014D2212C00002 J-Phase II StudyA 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 FibrosisIdiopathic Pulmonary FibrosisBiological: tralokinumab cohort 1;Biological: tralokinumab cohort 2;Other: PlaceboAstraZenecaMedImmune LLCCompleted50 YearsN/AAll37Phase 2Japan
213NCT02009293December 20131/12/2013The Effect of Pirfenidone on Cough in Patients With Idiopathic Pulmonary FibrosisObservational Study of the Effect of Pirfenidone on Cough in Patients With Idiopathic Pulmonary FibrosisIdiopathic Pulmonary FibrosisOther: Cough monitorErasmus Medical CenterUniversity of Catania;University of Lyon;King's College Hospital NHS Trust;Royal Brompton & Harefield NHS Foundation TrustCompleted40 Years85 YearsBoth43N/AFrance;Italy;Netherlands
214NCT01979952November 26, 20134/11/2013Nintedanib 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 MonthsIdiopathic Pulmonary FibrosisDrug: Matching Placebo;Drug: NintedanibBoehringer IngelheimNULLCompleted40 YearsN/AAll113Phase 3United States;Canada;Turkey
215NCT01777737November 25, 201325/1/2013Study to Test the Validity of the Treatment of Idiopathic Pulmonary Fibrosis With CotrimoxazolePilot Study Phase III to Evaluate the Efficacy and Safety of Trimethoprim-sulfamethoxazole in the Treatment of Idiopathic Pulmonary FibrosisIdiopathic Pulmonary FibrosisDrug: Cotrimoxazole;Drug: PlaceboFundación Pública Andaluza para la gestión de la Investigación en SevillaJunta de AndaluciaTerminated18 Years80 YearsAll3Phase 3Spain
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
216EUCTR2013-001163-24-IT19/11/201305/09/2013A 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 LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
250Phase 2France;United States;Mexico;Canada;Spain;Poland;Australia;Peru;Germany;Japan;United Kingdom;Italy
217NCT02013700November 13, 20132/12/2013Allogeneic 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 FibrosisIdiopathic Pulmonary Fibrosis (IPF)Biological: Allogeneic Adult Human Mesenchymal Stem Cells (hMSCs);Biological: matched placeboJoshua M HareThe Lester And Sue Smith Foundation;The Emmes Company, LLCCompleted40 Years90 YearsAll9Phase 1United States
218EUCTR2013-001163-24-PL09/11/201301/10/2013A 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 LtdNULLNot RecruitingFemale: yes
Male: yes
480Phase 2United States;Spain;United Kingdom;Italy;France;Mexico;Canada;Poland;Belgium;Australia;Peru;Germany;Japan
219EUCTR2013-001163-24-DE04/11/201328/08/2013A 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 LtdNULLNot RecruitingFemale: yes
Male: yes
480Phase 2United States;Spain;United Kingdom;Italy;France;Mexico;Canada;Belgium;Poland;Australia;Peru;Germany;Japan
220JPRN-UMIN0000211092013/10/2119/02/2016Preventive effect of Sivelestat Na Hydrate on postoperative acute exacerbation of idiopathic interstitial pneumonia in the patient with lung cancerPreventive 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)NULLComplete: follow-up complete25years-old80years-oldMale and Female120Phase 3Japan
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
221EUCTR2013-001163-24-GB14/10/201306/11/2013A 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]F. Hoffmann-La Roche LtdNULLNot Recruiting Female: yes
Male: yes
480 Human pharmacology (Phase 1): no Therapeut1c exploratory (Phase 2): yes Therapeut1c conf1rmatory - (Phase 3): no Therapeut1c use (Phase 4): noUnited States;Spain;United Kingdom;Italy;France;Mexico;Canada;Belgium;Poland;Australia;Peru;Germany;Japan
222NCT01872689October 13, 20135/6/2013A 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 FibrosisIdiopathic Pulmonary FibrosisDrug: Lebrikizumab;Drug: Pirfenidone;Drug: PlaceboHoffmann-La RocheNULLCompleted40 YearsN/AAll505Phase 2United States;Australia;Belgium;Canada;France;Germany;Italy;Japan;Mexico;Peru;Poland;Spain;United Kingdom
223EUCTR2013-003301-26-GB20/09/201304/11/2013A 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: 19.0Level: PTClassification code 10021240Term: Idiopathic pulmonary fibrosisSystem 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 TrustNULLNot RecruitingFemale: yes
Male: yes
Phase 2United Kingdom
224EUCTR2013-001163-24-ES20/09/201316/09/2013A 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 LtdNULLNot RecruitingFemale: yes
Male: yes
250Phase 2United States;Spain;United Kingdom;Italy;France;Mexico;Canada;Poland;Belgium;Peru;Australia;Germany;Japan
225EUCTR2013-001163-24-FR17/09/201328/09/2015A 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 LtdNULLNot RecruitingFemale: yes
Male: yes
250Phase 2United States;Spain;United Kingdom;Italy;France;Mexico;Canada;Poland;Belgium;Australia;Peru;Germany;Japan
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
226EUCTR2012-000564-14-GB11/09/201304/07/2013 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]
InterMune International AG.NULLNot Recruiting Female: yes
Male: yes
120 Human pharmacology (Phase 1): no Therapeut1c exploratory (Phase 2): yes Therapeut1c conf1rmatory - (Phase 3): no Therapeut1c use (Phase 4): noBelgium;Denmark;Austria;Germany;Italy;United Kingdom;Sweden
227EUCTR2012-001571-36-PL09/09/201317/06/2013A study to evaluate if a new drug is effective in preventing the progression of lung fibrosisA 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: 18.1Level: PTClassification code 10021240Term: Idiopathic pulmonary fibrosisSystem 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.NULLNot RecruitingFemale: yes
Male: yes
500Phase 2United States;Czech Republic;Canada;Spain;Belgium;Poland;Australia;Israel;Germany;United Kingdom;Italy;Korea, Republic of
228EUCTR2012-000564-14-DK28/08/201312/07/2013A 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 PirfenidoneA 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: 17.0Level: PTClassification code 10021240Term: Idiopathic pulmonary fibrosisSystem 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.NULLNot RecruitingFemale: yes
Male: yes
120Phase 2Belgium;Austria;Denmark;Germany;United Kingdom;Italy;Sweden
229NCT02707640August 20139/3/2016A 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 PirfenidoneIdiopathic Pulmonary FibrosisDrug: Matching Placebo;Drug: N-acetylcysteine;Drug: PirfenidoneHoffmann-La RocheNULLCompleted40 Years80 YearsAll123Phase 2Austria;Belgium;Denmark;France;Germany;Italy;Sweden;United Kingdom
230NCT01890265July 30, 201324/6/2013Evaluate 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 FibrosisIdiopathic Pulmonary FibrosisDrug: Pamrevlumab;Drug: Placebo;Drug: Sub-Study: Pirfenidone;Drug: Sub-Study: NintedanibFibroGenNULLCompleted40 Years80 YearsAll160Phase 2United States;Australia;Bulgaria;Canada;India;New Zealand;South Africa
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
231EUCTR2012-000564-14-AT19/07/201311/06/2013A 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 PirfenidoneA 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: 17.0Level: PTClassification code 10021240Term: Idiopathic pulmonary fibrosisSystem 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.NULLNot RecruitingFemale: yes
Male: yes
120Phase 2Belgium;Denmark;Austria;Germany;United Kingdom;Italy;Sweden
232EUCTR2012-000564-14-DE17/07/201329/05/2013A 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 PirfenidoneA 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: 17.0Level: PTClassification code 10021240Term: Idiopathic pulmonary fibrosisSystem 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.NULLNot RecruitingFemale: yes
Male: yes
120Phase 2Belgium;Denmark;Austria;Germany;United Kingdom;Italy;Sweden
233EUCTR2012-000564-14-IT17/07/201307/06/2013A 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 PirfenidoneA 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: 16.0Level: PTClassification code 10021240Term: Idiopathic pulmonary fibrosisSystem 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.NULLNot RecruitingFemale: yes
Male: yes
250Phase 2Belgium;Denmark;Austria;Germany;United Kingdom;Italy;Sweden
234EUCTR2012-000564-14-SE25/06/201324/05/2013A 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 PirfenidoneA 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: 17.0Level: PTClassification code 10021240Term: Idiopathic pulmonary fibrosisSystem 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.NULLNot RecruitingFemale: yes
Male: yes
120Phase 2Belgium;Denmark;Austria;Germany;United Kingdom;Italy;Sweden
235EUCTR2012-000564-14-BE18/06/201330/04/2013A 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 PirfenidoneA 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: 17.0Level: PTClassification code 10021240Term: Idiopathic pulmonary fibrosisSystem 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.NULLNot RecruitingFemale: yes
Male: yes
120Phase 2Belgium;Denmark;Austria;Germany;United Kingdom;Italy;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
236EUCTR2012-001571-36-DE17/06/201302/04/2013A study to evaluate if a new drug is effective in preventing the progression of lung fibrosisA 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: 18.0Level: PTClassification code 10021240Term: Idiopathic pulmonary fibrosisSystem 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.NULLNot RecruitingFemale: yes
Male: yes
500Phase 2United States;Czech Republic;Canada;Poland;Spain;Belgium;Australia;Israel;Germany;United Kingdom;Italy;Korea, Republic of
237EUCTR2012-001571-36-BE28/05/201326/03/2013A study to evaluate if a new drug is effective in preventing the progression of lung fibrosisA 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: 18.1Level: PTClassification code 10021240Term: Idiopathic pulmonary fibrosisSystem 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.NULLNot RecruitingFemale: yes
Male: yes
500Phase 2Korea, Democratic People's Republic of;Israel;United Kingdom;Switzerland;Italy;France;Czech Republic;Canada;Belgium;Poland;Australia;Germany;Korea, Republic of;United States;Spain
238EUCTR2012-001571-36-ES12/05/201316/05/2013A study to evaluate if a new drug is effective in preventing the progression of lung fibrosisA 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: 16.0Level: PTClassification code 10021240Term: Idiopathic pulmonary fibrosisSystem 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.NULLNot RecruitingFemale: yes
Male: yes
500Phase 2United States;Czech Republic;Canada;Poland;Belgium;Spain;Australia;Israel;Germany;United Kingdom;Italy;Korea, Republic of
239EUCTR2012-001571-36-CZ29/04/201315/04/2013A study to evaluate if a new drug is effective in preventing the progression of lung fibrosisA 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: 18.1Level: PTClassification code 10021240Term: Idiopathic pulmonary fibrosisSystem 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.NULLNot RecruitingFemale: yes
Male: yes
500Phase 2United States;Czech Republic;Canada;Poland;Spain;Belgium;Australia;Israel;Germany;United Kingdom;Italy;Korea, Republic of
240EUCTR2012-001571-36-IT26/04/201328/02/2013A study to evaluate if a new drug is effective in preventing the progression of lung fibrosisA 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: 14.1Level: PTClassification code 10021240Term: Idiopathic pulmonary fibrosisSystem 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.NULLNot RecruitingFemale: yes
Male: yes
500Phase 2United States;Czech Republic;Canada;Poland;Spain;Belgium;Australia;Israel;Germany;United Kingdom;Italy;Korea, Republic of
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
241EUCTR2011-002766-21-IE23/04/201315/02/2013Long 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]
Boehringer Ingelheim LimitedNULLNot Recruiting Female: yes
Male: yes
750 Human pharmacology (Phase 1): no Therapeut1c exploratory (Phase 2): no Therapeut1c conf1rmatory - (Phase 3): yes Therapeut1c use (Phase 4): noUnited 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
242EUCTR2012-005409-38-ES19/04/201329/01/2013First 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: 14.1Level: PTClassification code 10021240Term: Idiopathic pulmonary fibrosisSystem 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)NULLNot RecruitingFemale: yes
Male: yes
56Phase 3Spain
243EUCTR2012-001571-36-GB19/04/201328/03/2013A study to evaluate if a new drug is effective in preventing the progression of lung fibrosisA 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: 17.0Level: PTClassification code 10021240Term: Idiopathic pulmonary fibrosisSystem 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.NULLNot RecruitingFemale: yes
Male: yes
500Phase 2United States;Czech Republic;Canada;Poland;Spain;Belgium;Australia;Israel;Germany;Italy;United Kingdom;Korea, Republic of
244EUCTR2012-005794-31-GB25/03/201326/02/2013A 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: 16.1Level: LLTClassification code 10066656Term: Chronic coughSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
MedDRA version: 16.1Level: PTClassification code 10011224Term: CoughSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: VRP700
Product Code: VRP700
Verona Pharma plcNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
United Kingdom
245NCT01725139March 8, 20138/11/2012A 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 FibrosisDrug: GSK2126458;Drug: PlaceboGlaxoSmithKlineNULLCompleted45 YearsN/AAll17Phase 1United Kingdom
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
246NCT01919827March 20131/8/2013Study of Autologous Mesenchymal Stem Cells to Treat Idiopathic Pulmonary FibrosisTreatment of Idiopathic Pulmonary Fibrosis With Bone Marrow Derived Mesenchymal Stem CellsIdiopathic Pulmonary FibrosisBiological: Endobronchial infusion of adult mesenchymal stem cells;Biological: Autologous mesenchymal stem cells derived from bone marrowClinica Universidad de Navarra, Universidad de NavarraNULLCompleted30 Years80 YearsAll17Phase 1Spain
247NCT02594839February 20131/11/2015Safety and Efficacy of Allogeneic Mesenchymal Stem Cells in Patients With Rapidly Progressive Interstitial Lung DiseaseA Phase I-II Study to Evaluate Safety and Efficacy of Allogeneic Bone-Marrow Mesenchymal Stem Cells in Patients With Rapidly Progressive Interstitial Lung DiseaseIdiopathic Interstitial Pneumonia;Interstitial Lung Disease;Idiopathic Pulmonary FibrosisDrug: Bone marrow mesenchymal stem cells;Drug: PlaceboFederal Research Clinical Center of Federal Medical & Biological Agency, RussiaNULLCompleted20 Years80 YearsAll20Phase 1/Phase 2Russian Federation
248NCT01766817January 31, 201310/1/2013Safety and Efficacy of a Lysophosphatidic Acid Receptor Antagonist in Idiopathic Pulmonary FibrosisSafety and Efficacy of a Lysophosphatidic Acid Receptor Antagonist in Idiopathic Pulmonary FibrosisIdiopathic Pulmonary FibrosisDrug: BMS-986020;Drug: Placebo matching with BMS-986020Bristol-Myers SquibbNULLCompleted40 Years90 YearsAll325Phase 2United States;Australia;Chile;Colombia;Mexico;Peru
249JPRN-UMIN0000167062013/01/0704/03/2015Efficacy and safety of inhaled N-acetylcysteine in idiopathic pulmonary fibrosis Idiopathic pulmonary fibrosisN-acetylcysteine was administered by inhalation at the dose of 352.4 mg b.i.d. via an ultrasonic nebulizer.Saitama Red Cross HospitalNULLComplete: follow-up complete40years-oldNot applicableMale and Female25Not selectedJapan
250NCT01524068September 201227/1/2012A MultiCenter Study of Combined PEX, Rituximab, and Steroids in Acute Idiopathic Pulmonary Fibrosis ExacerbationsA Multicenter, Open-Label, Phase II Study of Combined Plasma Exchange (PEX), Rituximab, and Corticosteroids in Patients With Acute Idiopathic Pulmonary Fibrosis ExacerbationsIdiopathic Pulmonary FibrosisDrug: Standard Steroid Treatment;Drug: The Standard Steroid Treatment, Plasma Exchange and rituximabUniversity of PittsburghNULLWithdrawn18 Years90 YearsBoth0Phase 2United States
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
251EUCTR2011-002766-21-CZ03/08/201219/06/2012Long 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: 20.0Level: PTClassification code 10021240Term: Idiopathic pulmonary fibrosisSystem 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 KGNULLNot RecruitingFemale: yes
Male: yes
750Phase 3United 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
252JPRN-UMIN0000085412012/07/3030/07/2012The effect of pirfenidone on the mortality risk score in IPF idiopathic pulmonary fibrosispirfenidoneDepartment of Respiratory Medicine and Allergology, Kinki University Faculty of MedicineNULLComplete: follow-up complete20years-oldNot applicableMale and Female20Not appl1cableJapan
253EUCTR2011-002766-21-IT25/07/201219/06/2012Long 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: 14.1Level: PTClassification code 10021240Term: Idiopathic pulmonary fibrosisSystem 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.NULLNot RecruitingFemale: yes
Male: yes
750Phase 3Portugal;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
254NCT01371305July 16, 20123/6/2011STX-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: PlaceboBiogenNULLCompleted18 Years84 YearsAll41Phase 2United States
255EUCTR2011-002766-21-DE02/07/201204/05/2012Long 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: 18.0Level: PTClassification code 10021240Term: Idiopathic pulmonary fibrosisSystem 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. KGNULLNot RecruitingFemale: yes
Male: yes
750Phase 3United 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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
256EUCTR2011-002766-21-BE26/06/201226/04/2012Long 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: 17.1Level: PTClassification code 10021240Term: Idiopathic pulmonary fibrosisSystem 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.VNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
750United 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
257EUCTR2011-002766-21-ES18/06/201226/04/2012Long 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: 14.1Level: PTClassification code 10021240Term: Idiopathic pulmonary fibrosisSystem 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.ANULLNot RecruitingFemale: yes
Male: yes
750Phase 3United 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
258EUCTR2011-002766-21-GB15/06/201221/05/2012Long 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: 19.1Level: PTClassification code 10021240Term: Idiopathic pulmonary fibrosisSystem 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 LimitedNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
750Phase 3United 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
259EUCTR2011-002766-21-FI06/06/201216/05/2012Long 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: 17.1Level: PTClassification code 10021240Term: Idiopathic pulmonary fibrosisSystem 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 IngelheimNULLNot RecruitingFemale: yes
Male: yes
750Phase 3United 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
260JPRN-UMIN0000077742012/06/0116/04/2012Phase 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) non-small-cell lung cancer combined with idiopathic pulmonary fibrosisOral administration of pirfenidone starting from 4-6 weeks before the surgery.West Japan Oncology GroupNULLComplete: follow-up complete20years-old75years-oldMale and Female42Phase 2Japan
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
261EUCTR2011-002766-21-GR02/05/201211/04/2012Long 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: 14.1Level: PTClassification code 10021240Term: Idiopathic pulmonary fibrosisSystem 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 HellasNULLNot RecruitingFemale: yes
Male: yes
750Phase 3United 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
262EUCTR2011-002766-21-PT20/04/201220/04/2012Long 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: 20.0Level: PTClassification code 10021240Term: Idiopathic pulmonary fibrosisSystem 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, LdaNULLNot RecruitingFemale: yes
Male: yes
750Phase 3United 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
263NCT01529853April 20126/2/2012To 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 FibrosisDrug: SAR156597;Drug: PlaceboSanofiNULLCompleted18 YearsN/ABoth24Phase 1/Phase 2United States;Canada;Chile;Mexico;Spain;Belgium
264NCT01457261April 201219/10/2011IPF Drug Deposition StudyA Study of the Pharmacokinetics and Deposition of Inhaled Salbutamol in Patients With Idiopathic Pulmonary Fibrosis (TOPICAL-IPF)Idiopathic Pulmonary FibrosisDrug: SalbutamolRoyal Brompton & Harefield NHS Foundation TrustGlaxoSmithKlineCompleted40 YearsN/ABoth10Phase 1United Kingdom
265EUCTR2011-003687-78-IT21/02/201205/03/2012Lanreotide 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: 14.1Level: PTClassification code 10021240Term: Idiopathic pulmonary fibrosisSystem 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. MALPIGHINULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
Italy
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
266NCT02699879February 16, 201226/2/2016Evaluation 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 SettingIdiopathic Pulmonary FibrosisDrug: PirfenidoneHoffmann-La RocheNULLCompletedN/AN/AAll1009N/AAustria;Denmark;Finland;France;Germany;Ireland;Italy;Norway;Sweden;United Kingdom
267NCT01504334January 201230/12/2011Safety 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 FibrosisDrug: Pirfenidone;Drug: PlaceboBeijing Kawin Technology Share-Holding Co., Ltd.NULLRecruiting18 Years75 YearsBoth80Phase 2China
268NCT02136992December 201111/5/2014Clinical Efficacy and Safety of Pirfenidone in Patients With Idiopathic Pulmonary FibrosisA Multicenter, Randomized, Double-blind, Placebo-controlled Trial for Clinical Efficacy and Safety of Pirfenidone in Patients With Idiopathic Pulmonary FibrosisIdiopathic Pulmonary FibrosisDrug: Pirfenidone;Drug: placeboShanghai Pulmonary Hospital, Shanghai, ChinaNanjing Chia-tai Tianqing PharmaceuticalCompletedN/A75 YearsBoth160Phase 2NULL
269NCT01417156September 201115/8/2011Safety 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 FibrosisPulmonary FibrosisDrug: Nintedanib;Drug: PirfenidoneoneBoehringer IngelheimNULLCompleted40 YearsN/AAll20Phase 2Japan
270NCT01382368September 20112/5/2011Acute Effect of Sildenafil on Exercise Tolerance and Functional Capacity in COPD, IPF and Post Pneumonectomy PatientsAcute Effect of Sildenafil on Exercise Tolerance and Functional Capacity in COPD, IPF and Post Pneumonectomy PatientsChronic Obstructive Pulmonary Disease;Idiopathic Pulmonary FibrosisDrug: SildenafilRabin Medical CenterNULLEnrolling by invitation30 Years90 YearsBoth60Phase 4Israel
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
271EUCTR2010-024211-13-DE20/07/201112/04/2011Study to evaluate if macitentan is safe and tolerable enough to be used for treatment of idiopathic pulmonary fibrosis, following the MUSIC studyLong 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: 13.1Level: PTClassification code 10021240Term: Idiopathic pulmonary fibrosisSystem 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.NULLNot RecruitingFemale: yes
Male: yes
178Germany;Canada;Turkey;Spain;United States;Sweden;South Africa;Australia;Israel
272NCT01214187July 201130/9/2010Study of Inhaled Carbon Monoxide to Treat Idiopathic Pulmonary FibrosisPhase II Study of Inhaled CO for the Treatment of Idiopathic Pulmonary FibrosisIdiopathic Pulmonary FibrosisDrug: inhaled carbon monoxide;Other: OxygenBrigham and Women's HospitalNational 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 WashingtonCompleted18 Years85 YearsAll58Phase 2United States
273EUCTR2010-020688-18-GB29/06/201128/01/2011Safety 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: 14.1Level: PTClassification code 10021240Term: Idiopathic pulmonary fibrosisSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
Product Code: QAX576Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
40United Kingdom
274EUCTR2010-024211-13-ES27/06/201110/11/2011Study to evaluate if macitentan is safe and tolerable enough to be usedfor treatment of idiopathic pulmonary fibrosis, following the MUSICstudyLong 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: 14.0Level: PTClassification code 10021240Term: Idiopathic pulmonary fibrosisSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
MedDRA version: 14.0Level: SOCClassification code 10038738Term: Respiratory, thoracic and mediastinal disordersSystem 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.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
178Germany;Canada;Turkey;Spain;United States;Sweden;South Africa;Australia;Israel
275EUCTR2010-024252-29-NL16/06/201111/05/2011A 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: 12.1Level: PTClassification code 10021240Term: Idiopathic pulmonary fibrosis
Product Name: BIBF 1120
Product Code: BIBF 1120
Product Name: BIBF 1120
Product Code: BIBF 1120
Boehringer IngelheimNULLNot RecruitingFemale: yes
Male: yes
485Portugal;Greece;Finland;Spain;Germany;Netherlands
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
276EUCTR2010-024211-13-SI13/06/201111/07/2011Study to evaluate if macitentan is safe and tolerable enough to be used for treatment of idiopathic pulmonary fibrosis, following the MUSIC studyLong 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: 14.0Level: PTClassification code 10021240Term: Idiopathic pulmonary fibrosisSystem 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.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
178United States;Slovenia;Canada;Spain;Turkey;Australia;Israel;South Africa;Germany;Sweden
277EUCTR2010-023828-24-GB09/06/201127/04/2011The effect of Thalidomide on sputum biomarkers in IPF cough. - The effect of Thalidomide on sputum biomarkers in IPF coughThe 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 NottinghamNULLNot RecruitingFemale: yes
Male: yes
United Kingdom
278NCT01366209June 20112/6/2011Efficacy 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 FibrosisDrug: Pirfenidone;Drug: PlaceboGenentech, Inc.NULLCompleted40 Years80 YearsAll555Phase 3United States
279EUCTR2010-024211-13-SE26/05/201105/04/2011Study to evaluate if macitentan is safe and tolerable enough to be used for treatment of idiopathic pulmonary fibrosis, following the MUSIC studyLong 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: 13.1Level: PTClassification code 10021240Term: Idiopathic pulmonary fibrosisSystem 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.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
178Germany;Canada;Turkey;Spain;United States;South Africa;Australia;Sweden;Israel
280EUCTR2010-024252-29-ES25/05/201103/11/2011-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: 14.0Level: PTClassification code 10021240Term: Idiopathic pulmonary fibrosisSystem 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.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
485Portugal;Germany;Turkey;Netherlands;Chile;France;Finland;India;Russian Federation;Canada;Mexico;China;Korea, Republic of;Spain;Japan;United States;Greece
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
281EUCTR2010-024251-87-BE18/05/201117/03/2011A 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: 14.1Level: PTClassification code 10021240Term: Idiopathic pulmonary fibrosisSystem 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.VNULLNot RecruitingFemale: yes
Male: yes
485Phase 3United States;Ireland;Israel;Italy;United Kingdom;India;France;Czech Republic;Argentina;Belgium;Brazil;Australia;Germany;Japan;China
282EUCTR2010-024252-29-PT13/05/201116/02/2011A 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: 14.0Level: PTClassification code 10021240Term: Idiopathic pulmonary fibrosisSystem 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 FranceNULLNot RecruitingFemale: yes
Male: yes
485China;Japan;Korea, Republic of;United States;Portugal;Greece;Finland;Spain;Russian Federation;India;France;Mexico;Canada;Germany;Netherlands
283EUCTR2010-024251-87-IE11/05/201123/03/2011A 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: 14.1Level: PTClassification code 10021240Term: Idiopathic pulmonary fibrosisSystem 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 LimitedNULLNot RecruitingFemale: yes
Male: yes
485Czech Republic;Belgium;Ireland;Germany;Italy;United Kingdom
284EUCTR2010-024251-87-IT10/05/201119/09/2011A 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: 14.0Level: PTClassification code 10021240Term: Idiopathic pulmonary fibrosisSystem 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.NULLNot RecruitingFemale: yes
Male: yes
646Czech Republic;Belgium;Ireland;Germany;United Kingdom;Italy
285EUCTR2010-024252-29-GR02/05/201104/04/2011A 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: 13.1Level: PTClassification code 10021240Term: Idiopathic pulmonary fibrosisSystem 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 IngelheimNULLNot RecruitingFemale: yes
Male: yes
485Portugal;Greece;Finland;Spain;Netherlands;Germany
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
286NCT01335477May 201113/4/2011Safety and Efficacy of BIBF 1120 at High Dose in Idiopathic Pulmonary Fibrosis Patients IIA 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 FibrosisDrug: placebo;Drug: BIBF 1120Boehringer IngelheimNULLCompleted40 YearsN/AAll551Phase 3United States;Canada;Chile;China;Finland;France;Germany;Greece;India;Japan;Korea, Republic of;Mexico;Netherlands;Portugal;Russian Federation;Spain;Turkey
287EUCTR2010-024251-87-GB28/04/201124/02/2011Safety and efficacy of BIBF 1120 at high dose in Idiopathic Pulmonary Fibrosis patientsA 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: 14.1Level: PTClassification code 10021240Term: Idiopathic pulmonary fibrosisSystem 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 LimitedNULLNot RecruitingFemale: yes
Male: yes
485Phase 3Czech Republic;Belgium;Ireland;Germany;Italy;United Kingdom
288EUCTR2010-024251-87-CZ26/04/201108/04/2011Safety and Efficacy of BIBF 1120 at high dose in Idiopathic Pulmonary Fibrosis patientsA 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: 14.1Level: PTClassification code 10021240Term: Idiopathic pulmonary fibrosisSystem 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 KGNULLNot RecruitingFemale: yes
Male: yes
485India;Czech Republic;Argentina;Brazil;Belgium;Australia;Germany;China;Japan;United States;Ireland;Israel;Italy;United Kingdom
289EUCTR2010-024251-87-DE12/04/201109/02/2011Safety and Efficacy of BIBF 1120 at high dose in Idiopathic Pulmonary Fibrosis patientsA 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: 14.1Level: PTClassification code 10021240Term: Idiopathic pulmonary fibrosisSystem 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. KGNULLNot RecruitingFemale: yes
Male: yes
485United States;Ireland;Israel;Italy;United Kingdom;India;France;Czech Republic;Argentina;Belgium;Brazil;Australia;Germany;Japan;China
290EUCTR2010-024252-29-DE07/04/201109/02/2011Safety and Efficacy of BIBF 1120 at high dose in Idiopathic Pulmonary Fibrosis patientsA 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: 14.1Level: PTClassification code 10021240Term: Idiopathic pulmonary fibrosisSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
MedDRA version: 14.1Level: PTClassification code 10037383Term: Pulmonary fibrosisSystem 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. KGNULLNot RecruitingFemale: yes
Male: yes
485Portugal;United States;Greece;Finland;Spain;Turkey;Russian Federation;Chile;India;France;Mexico;Canada;Netherlands;Germany;Japan;China;Korea, Republic of
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
291EUCTR2010-024252-29-FI01/04/201104/02/2011A 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: 12.1Level: PTClassification code 10021240Term: Idiopathic pulmonary fibrosis
Product Name: BIBF 1120
Product Code: BIBF 1120
Product Name: BIBF 1120
Product Code: BIBF 1120
Boehringer IngelheimNULLNot RecruitingFemale: yes
Male: yes
485Portugal;Greece;Finland;Spain;Netherlands;Germany
292NCT01335464April 201113/4/2011Safety and Efficacy of BIBF 1120 at High Dose in Idiopathic Pulmonary Fibrosis PatientsA 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 FibrosisDrug: placebo;Drug: BIBF 1120Boehringer IngelheimNULLCompleted40 YearsN/AAll515Phase 3United States;Australia;Belgium;China;Czech Republic;France;Germany;India;Ireland;Israel;Italy;Japan;United Kingdom;Argentina;Brazil
293NCT01265888March 201120/12/2010Study 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 FibrosisDrug: Inhaled Nitric OxideGeno LLCNULLCompleted18 Years80 YearsBoth31Phase 2United States
294NCT01262001March 201115/12/2010Safety, Tolerability, and Efficacy Study of Idiopathic Pulmonary FibrosisA Phase 2, Open-Label, Dose-Escalation Study to Evaluate the Safety, Tolerability, and Efficacy of FG-3019 in Subjects With Idiopathic Pulmonary FibrosisIdiopathic Pulmonary FibrosisDrug: FG-3019FibroGenNULLCompleted35 Years80 YearsAll90Phase 2United States
295NCT01266317March 201122/12/2010Combined PEX, Rituximab and Steroids in Acute Idiopathic Pulmonary Fibrosis ExacerbationsOpen-Label, Feasibility Study of Combined Plasma Exchange (PEX), Rituximab, and Corticosteroids in Patients With Acute Idiopathic Pulmonary Fibrosis ExacerbationsIPFDrug: Combined Plasma Exchange (PEX), Rituximab, and CorticosteroidsMichael DonahoeNULLCompleted18 Years80 YearsAll9Phase 1/Phase 2United States
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
296ChiCTR-TRC-120023722011-02-232012-07-15Levofloxacin (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 fibrosisCravit 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 HospitalNULLCompleted1870BothCravit IPF Group:12;Cravit Normal Pulmonary Function Group:12;Moxifloxacin IPF Group:12;Moxifloxacin Normal PulmonaryFunction Group:12;China
297JPRN-UMIN0000050982011/02/0118/02/2011A randomized trial of ambulatory oxygen in patients with idiopathic pulmonary fibrosis and desaturation but without resting hypoxemia idiopathic pulmonary fibrosisambulatory oxygen
ambulatory air
Department of Respiratory Medicine and Allergology, Kinki University School of MedicineNULLComplete: follow-up complete20years-oldNot applicableMale and Female20Not selectedJapan
298EUCTR2009-011169-98-CZ10/01/201129/11/2010ARTEMIS-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-PHARTEMIS-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: 12.1Level: LLTClassification code 10021240Term: Idiopathic pulmonary fibrosis
MedDRA version: 12.1Level: LLTClassification code 10037400Term: Pulmonary hypertension
Trade Name: Letairis
INN or Proposed INN: Ambrisentan
Trade Name: Letairis
INN or Proposed INN: Ambrisentan
Gilead Sciences, Inc.NULLNot RecruitingFemale: yes
Male: yes
225Phase 3United Kingdom;Germany;Czech Republic;Italy;Austria
299JPRN-UMIN0000047492011/01/0118/12/2010A 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 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 even
Department of Respiratory Medicine, Chiba-Hokusoh Hospital, Nippon Medical SchoolNULLRecruiting40years-oldNot applicableMale and Female160Not appl1cableJapan
300NCT01254409January 20113/12/2010A 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 FibrosisIdiopathic Pulmonary FibrosisBiological: PRM-151;Other: PlaceboHoffmann-La RocheNULLCompleted40 Years80 YearsAll21Phase 1United States;Netherlands
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
301NCT01362231December 201012/4/2011A Study to Evaluate the Safety and Efficacy of GS-6624 (Formerly AB0024) in Patients With Idiopathic Pulmonary FibrosisA Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of GS-6624 in Adult Subjects With Idiopathic Pulmonary FibrosisIdiopathic Pulmonary FibrosisDrug: GS-6624Gilead SciencesNULLCompleted40 Years85 YearsBoth48Phase 1United States
302NCT01266135December 201017/12/2010Safety 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 IPFIdiopathic Pulmonary FibrosisDrug: QAX576;Drug: PlaceboNovartis PharmaceuticalsNULLTerminated18 Years80 YearsAll40Phase 2United States;United Kingdom
303EUCTR2009-013788-21-BG05/10/201018/08/2010A phase II open label, roll over study of the long term tolerability,safety and efficacy of oral BIBF 1120 in patients with IdiopathicPulmonary FibrosisA 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: 16.1Level: PTClassification code 10021240Term: Idiopathic pulmonary fibrosisSystem 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 KGNULLNot RecruitingFemale: yes
Male: yes
300Phase 2Portugal;France;Czech Republic;Hungary;Greece;Belgium;Spain;Ireland;Bulgaria;Germany;United Kingdom;Italy
304EUCTR2008-004405-34-CZ13/09/201007/01/2009A 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-IPFA 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: 9.1Level: LLTClassification code 10021240Term: 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 IncorporatedNULLNot RecruitingFemale: yes
Male: yes
660Phase 3United Kingdom;Germany;Czech Republic;Netherlands;Belgium;France;Spain;Ireland;Italy;Austria
305NCT01199887September 20109/9/2010Trial Of IW001 in Patients With Idiopathic Pulmonary FibrosisA 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 FibrosisDrug: IW001ImmuneWorksNULLCompleted35 Years75 YearsBoth30Phase 1United States
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
306EUCTR2009-013788-21-IE05/08/201020/05/2010A phase II open label, roll over study of the long term tolerability,safety and efficacy of oral BIBF 1120 in patients with IdiopathicPulmonary FibrosisA 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: 12.1Level: PTClassification code 10021240Term: 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 LtdNULLNot RecruitingFemale: yes
Male: yes
300Phase 2Portugal;France;Czech Republic;Hungary;Greece;Belgium;Spain;Ireland;Bulgaria;Germany;United Kingdom;Italy
307EUCTR2010-020223-44-AT03/08/201029/06/2010(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 etiologyTrade Name: (18)F-FDG
Product Name: (18)F-FDG
INN or Proposed INN: FLUORINE (18F) FLUDEOXYGLUCOSE
Medizinische Universität Wien, Univ.Klinik f.RadiodiagnostikNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
Austria
308EUCTR2008-001281-86-DE02/08/201016/03/2010A 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 FibrosisA 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: 9.1Level: LLTClassification code 10021240Term: Idiopathic pulmonary fibrosis
Product Name: CNTO888
Product Code: CNTO888
Janssen Biologics B.V.NULLNot RecruitingFemale: yes
Male: yes
120Phase 2Germany;Netherlands;Belgium
309EUCTR2009-013788-21-CZ02/08/201028/07/2010study of the long term tolerability, safety and efficacy of oral BIBF 1120 in patients with Idiopathic Pulmonary FibrosisA 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: 19.0Level: PTClassification code 10021240Term: Idiopathic pulmonary fibrosisSystem 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 KGNULLNot RecruitingFemale: yes
Male: yes
300Phase 2Portugal;Greece;Spain;Ireland;Russian Federation;Italy;United Kingdom;France;Czech Republic;Hungary;Belgium;Bulgaria;Germany
310EUCTR2009-013788-21-GR14/07/201015/11/2010A phase II open label, roll over study of the long term tolerability,safety and efficacy of oral BIBF 1120 in patients with IdiopathicPulmonary FibrosisA 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: 12.1Level: PTClassification code 10021240Term: 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 AENULLNot RecruitingFemale: yes
Male: yes
300Phase 2Portugal;France;Czech Republic;Hungary;Greece;Belgium;Spain;Ireland;Bulgaria;Germany;United Kingdom;Italy
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
311NCT01170065June 25, 20106/7/2010Roll 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 FibrosisPulmonary FibrosisDrug: BIBF 1120Boehringer IngelheimNULLCompleted40 YearsN/AAll198Phase 2Argentina;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
312EUCTR2009-013788-21-HU16/06/201005/07/2010A phase II open label, roll over study of the long term tolerability, safety and efficacy of oral BIBF 1120 in patients with Idiopathic Pulmonary FibrosisA 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: 17.0Level: PTClassification code 10021240Term: Idiopathic pulmonary fibrosisSystem 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 KGNULLNot RecruitingFemale: yes
Male: yes
300Phase 2Portugal;France;Czech Republic;Hungary;Greece;Belgium;Spain;Ireland;Bulgaria;Germany;United Kingdom;Italy
313EUCTR2009-013788-21-GB04/06/201011/10/2010A phase II open label, roll over study of the long term tolerability,safety and efficacy of oral BIBF 1120 in patients with IdiopathicPulmonary FibrosisA 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: 18.0Level: PTClassification code 10021240Term: Idiopathic pulmonary fibrosisSystem 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 LimitedNULLNot RecruitingFemale: yes
Male: yes
300Phase 2Portugal;France;Czech Republic;Hungary;Greece;Belgium;Spain;Ireland;Bulgaria;Germany;Italy;United Kingdom
314NCT01135199June 201028/5/2010Pomalidomide for Cough in Patients With Idiopathic Pulmonary FibrosisSafety and Efficacy of Pomalidomide in the Treatment of Refractory Cough in Patients With Idiopathic Pulmonary Fibrosis (IPF): A Pilot StudyPulmonary FibrosisDrug: pomalidomide (CC-4047Stanford UniversityCelgene CorporationWithdrawn18 YearsN/ABoth0Phase 2United States
315EUCTR2009-013788-21-DE27/05/201022/04/2010Roll 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: 18.0Level: PTClassification code 10021240Term: Idiopathic pulmonary fibrosisSystem 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. KGNULLNot RecruitingFemale: yes
Male: yes
300Phase 2Portugal;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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
316EUCTR2009-013788-21-PT10/05/201018/03/2010A phase II open label, roll over study of the long term tolerability,safety and efficacy of oral BIBF 1120 in patients with IdiopathicPulmonary FibrosisA 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: 17.1Level: PTClassification code 10021240Term: Idiopathic pulmonary fibrosisSystem 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.NULLNot RecruitingFemale: yes
Male: yes
300Phase 2France;Portugal;Czech Republic;Hungary;Greece;Belgium;Spain;Ireland;Bulgaria;Germany;United Kingdom;Italy
317NCT01136174May 201031/5/2010Safety and PK Study of BIBF 1120 in Japanese Patients With IPFA 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 FibrosisDrug: Placebo;Drug: BIBF 1120Boehringer IngelheimNULLCompleted40 YearsN/AAll50Phase 2Japan
318EUCTR2009-013788-21-ES28/04/201023/02/2010Ensayo 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 FibrosisEnsayo 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: 12.1Level: PTClassification code 10021240Term: 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.NULLNot RecruitingFemale: yes
Male: yes
300Phase 2Portugal;France;Czech Republic;Hungary;Greece;Belgium;Spain;Ireland;Bulgaria;Germany;United Kingdom;Italy
319EUCTR2009-013788-21-BE22/04/201008/03/2010A phase II open label, roll over study of the long term tolerability,safety and efficacy of oral BIBF 1120 in patients with IdiopathicPulmonary FibrosisA 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: 17.0Level: PTClassification code 10021240Term: Idiopathic pulmonary fibrosisSystem 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.VNULLNot RecruitingFemale: yes
Male: yes
300Phase 2Portugal;France;Czech Republic;Hungary;Greece;Spain;Belgium;Ireland;Bulgaria;Germany;United Kingdom;Italy
320EUCTR2009-013788-21-FR09/04/201008/03/2010A phase II open label, roll over study of the long term tolerability,safety and efficacy of oral BIBF 1120 in patients with IdiopathicPulmonary FibrosisA 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: 12.1Level: PTClassification code 10021240Term: 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 FranceNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
300Phase 2Hungary;Portugal;United Kingdom;Czech Republic;Germany;Belgium;Bulgaria;France;Ireland;Spain;Italy;Greece
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
321EUCTR2009-013788-21-IT07/04/201026/03/2010A 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 - NDA 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: 9.1Level: LLTClassification code 10021240
Product Code: BIBF 1120
Product Code: BIBF 1120
Product Code: BIBF 1120
BOEHRINGER ING.NULLNot RecruitingFemale: yes
Male: yes
350Phase 2Portugal;France;Czech Republic;Hungary;Greece;Belgium;Spain;Ireland;Bulgaria;Germany;United Kingdom;Italy
322EUCTR2008-006054-17-IT26/01/201022/10/2009A double-blind, randomized, placebo-controlled, multicenter, parallel group study to evaluate the efficacy, safety, and tolerability of macitentan in patients with idiopathic pulmonary fibrosis. - MUSICA 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: 9.1Level: LLTClassification code 10021240
Product Name: Macitentan
Product Code: ACT-064992
INN or Proposed INN: Macitentan
Actelion Pharamceuticals LtdNULLNot RecruitingFemale: yes
Male: yes
156Germany;Slovenia;France;Spain;Italy;Sweden
323EUCTR2009-011169-98-AT26/11/200925/08/2009ARTEMIS-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-PHARTEMIS-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: 12.0Level: LLTClassification code 10021240Term: Idiopathic pulmonary fibrosis
MedDRA version: 12.0Level: LLTClassification code 10037400Term: Pulmonary hypertension
Trade Name: Letairis
INN or Proposed INN: Ambrisentan
Trade Name: Letairis
INN or Proposed INN: Ambrisentan
Gilead Sciences, IncNULLNot RecruitingFemale: yes
Male: yes
225Phase 3Czech Republic;United Kingdom;Germany;Italy;Austria
324EUCTR2009-011169-98-DE03/11/200906/08/2009ARTEMIS-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-PHARTEMIS-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: 12.0Level: LLTClassification code 10021240Term: Idiopathic pulmonary fibrosis
MedDRA version: 12.0Level: LLTClassification code 10037400Term: Pulmonary hypertension
Trade Name: Letairis
INN or Proposed INN: Ambrisentan
Trade Name: Letairis
INN or Proposed INN: Ambrisentan
Gilead Sciences, IncNULLNot RecruitingFemale: yes
Male: yes
225Phase 3Czech Republic;United Kingdom;Germany;Italy;Austria
325EUCTR2009-011169-98-GB30/10/200901/09/2009ARTEMIS-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-PHARTEMIS-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: 12.0Level: LLTClassification code 10021240Term: Idiopathic pulmonary fibrosis
MedDRA version: 12.0Level: LLTClassification code 10037400Term: Pulmonary hypertension
Trade Name: Letairis
INN or Proposed INN: Ambrisentan
Trade Name: Letairis
INN or Proposed INN: Ambrisentan
Gilead Sciences, IncNULLNot RecruitingFemale: yes
Male: yes
225Phase 3Czech Republic;Germany;United Kingdom;Italy;Austria
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
326JPRN-UMIN0000160452009/10/0326/12/2014A 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 fibrosisUsing 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,NULLComplete: follow-up complete20years-oldNot applicableMale and Female20Not selectedJapan
327EUCTR2009-011169-98-IT22/09/200921/09/2009A 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 - NDA 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: 9.1Level: LLTClassification code 10021240
MedDRA version: 9.1Level: LLTClassification code 10037400
Trade Name: Letairis
Trade Name: Letairis
Gilead Sciences IncorporatedNULLNot RecruitingFemale: yes
Male: yes
225Phase 3Czech Republic;United Kingdom;Germany;Italy;Austria
328EUCTR2008-004405-34-IE08/09/200907/01/2009A 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) - ARTEMISA 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: 9.1Level: LLTClassification code 10021240Term: 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 IncorporatedNULLNot RecruitingFemale: yes
Male: yes
600Phase 3United Kingdom;Germany;Czech Republic;Netherlands;Belgium;France;Spain;Ireland;Italy;Austria
329EUCTR2008-006054-17-SE12/08/200925/06/2009A double-blind, randomized, placebo-controlled, multicenter, parallel group study to evaluate the efficacy, safety, and tolerability of macitentan in patients with idiopathic pulmonary fibrosis - MUSICA 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: 9.1Level: LLTClassification code 10021240Term: Idiopathic pulmonary fibrosis
Product Name: macitentan
Product Code: ACT-064992
INN or Proposed INN: macitentan
Actelion Pharmaceuticals Ltd.NULLNot RecruitingFemale: yes
Male: yes
156Germany;Slovenia;France;Spain;Italy;Sweden
330EUCTR2008-004405-34-IT03/08/200927/07/2009A 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-IPFA 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: 12.0Level: LLTClassification code 10021240Term: Idiopathic pulmonary fibrosis
Trade Name: VOLIBRIS
INN or Proposed INN: Ambrisentan
Trade Name: VOLIBRIS
INN or Proposed INN: Ambrisentan
Gilead Sciences IncorporatedNULLNot RecruitingFemale: yes
Male: yes
600Phase 3United Kingdom;Germany;Czech Republic;Netherlands;Belgium;France;Spain;Ireland;Italy;Austria
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
331EUCTR2008-004405-34-GB08/06/200928/04/2009ARTEMIS-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-IPFARTEMIS-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: 9.1Level: LLTClassification code 10021240Term: 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 IncorporatedNULLNot RecruitingFemale: yes
Male: yes
660Phase 3Germany;Czech Republic;United Kingdom;Netherlands;Belgium;France;Spain;Ireland;Italy;Austria
332EUCTR2008-004405-34-NL04/06/200910/03/2009A 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-IPFA 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: 9.1Level: LLTClassification code 10021240Term: 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 IncorporatedNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
660Phase 3United Kingdom;Germany;Czech Republic;Netherlands;Belgium;France;Spain;Ireland;Italy;Austria
333EUCTR2008-006054-17-ES20/05/200901/04/2009Estudio 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. - MUSICEstudio 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: 9.1Level: LLTClassification code 10021240Term: Idiopathic pulmonary fibrosis
Product Name: Macitentan
Product Code: ACT-064992
INN or Proposed INN: Macitentan
Actelion Pharmaceuticals Ltd.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
156Germany;Slovenia;France;Spain;Italy;Sweden
334NCT00903331May 200914/5/2009Macitentan Use in an Idiopathic Pulmonary Fibrosis Clinical StudyA Double-blind, Randomized, Placebo-controlled, Multicenter, Parallel Group Study to Evaluate the Efficacy, Safety, and Tolerability of Macitentan in Patients With Idiopathic Pulmonary FibrosisIdiopathic Pulmonary FibrosisDrug: ACT-064992 (macitentan);Drug: PlaceboActelionNULLCompleted18 YearsN/AAll178Phase 2United States;Australia;Canada;France;Germany;Israel;Italy;Slovenia;South Africa;Spain;Sweden;Turkey
335EUCTR2008-006054-17-FR29/04/200925/03/2009MUSIC: 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 - MUSICMUSIC: 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 fibrosisProduct Name: ACT-064992
Product Code: ACT-064992
INN or Proposed INN: MACITENTAN
Actelion Pharmaceuticals Ltd.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
156Germany;Slovenia;France;Spain;Italy;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
336EUCTR2008-001281-86-BE24/04/200915/10/2008A 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 FibrosisA 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: 9.1Level: LLTClassification code 10021240Term: Idiopathic pulmonary fibrosis
Product Name: CNTO888
Product Code: CNTO888
Janssen Biologics B.V.NULLNot RecruitingFemale: yes
Male: yes
120Phase 2Belgium;Germany;Netherlands
337EUCTR2007-001741-18-AT02/04/200907/04/2008Open-label extension study in patients with Idiopathic Pulmonary Fibrosis who completed protocol AC-052-321 / BUILD 3 - BUILD-3-OLOpen-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: 9.1Level: LLTClassification code 10021240Term: 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 LtdNULLNot RecruitingFemale: yes
Male: yes
390Germany;Czech Republic;United Kingdom;Netherlands;Belgium;France;Ireland;Spain;Italy;Austria
338EUCTR2008-006054-17-SI31/03/200906/04/2009A double-blind, randomized, placebo-controlled, multicenter, parallel group study to evaluate the efficacy, safety, and tolerability of macitentan in patients with idiopathic pulmonary fibrosis - MUSICA 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: 9.1Level: LLTClassification code 10021240Term: Idiopathic pulmonary fibrosis
Product Name: Macitentan
Product Code: ACT-064992
INN or Proposed INN: Macitentan
Actelion Pharmaceuticals Ltd.NULLNot RecruitingFemale: yes
Male: yes
156Germany;Slovenia;France;Spain;Italy;Sweden
339EUCTR2008-004405-34-ES27/03/200928/01/2009ARTEMIS: 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). - ARTEMISARTEMIS: 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: 9.1Level: LLTClassification code 10021240Term: 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 IncorporatedNULLNot RecruitingFemale: yes
Male: yes
600Phase 3United Kingdom;Germany;Czech Republic;Netherlands;Belgium;France;Ireland;Spain;Italy;Austria
340EUCTR2008-004405-34-AT13/03/200921/01/2009A 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) - ARTEMISA 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: 9.1Level: LLTClassification code 10021240Term: 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 IncorporatedNULLNot RecruitingFemale: yes
Male: yes
600Phase 3United Kingdom;Germany;Czech Republic;Netherlands;Belgium;France;Spain;Ireland;Italy;Austria
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
341EUCTR2008-004405-34-BE09/03/200922/01/2009A 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-IPFA 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: 9.1Level: LLTClassification code 10021240Term: 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 IncorporatedNULLNot RecruitingFemale: yes
Male: yes
660Phase 3United Kingdom;Germany;Czech Republic;Netherlands;Belgium;France;Spain;Ireland;Italy;Austria
342NCT00879879March 200910/4/2009Losartan in Treating Patients With Idiopathic Pulmonary FibrosisTreatment of Idiopathic Pulmonary Fibrosis With Losartan: A Pilot ProjectPrecancerous ConditionDrug: losartanUniversity of South FloridaNational Cancer Institute (NCI)Completed21 YearsN/AAll20N/AUnited States
343EUCTR2008-004405-34-FR09/02/200916/03/2009A 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) - ARTEMISA 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: 9.1Level: LLTClassification code 10021240Term: 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 IncorporatedNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
600Phase 3United Kingdom;Germany;Czech Republic;Netherlands;Belgium;France;Spain;Ireland;Italy;Austria
344EUCTR2008-007168-40-IT20/01/200909/03/2009Use of 68Ga-DOTA-NOC for the evaluation of patients with Idiopathic pulmonary fibrosisSTUDY CODE: 68Ga-DOTA-NOC/ILD 01/2008 - 68Ga-DOTA-NOC/ILD01/2008Use 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: 9.1Level: LLTClassification code 10021240Term: Idiopathic pulmonary fibrosis
Product Name: Gallium68-Dota-NocAZIENDA OSPEDALIERA DI BOLOGNA POLICLINICO S. ORSOLA M. MALPIGHINULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
Italy
345EUCTR2008-001281-86-NL14/01/200925/09/2008A 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 FibrosisA 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: 9.1Level: LLTClassification code 10021240Term: Idiopathic pulmonary fibrosis
Product Name: CNTO888
Product Code: CNTO888
Centocor B.V.NULLNot RecruitingFemale: yes
Male: yes
120Phase 2Germany;Netherlands;Belgium
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
346JPRN-UMIN0000252562009/01/0113/12/2016Benefits of supplemental oxygen on exercise capacity and dyspnea in IPF patients idiopathic pulmonary fibrosisoxygen gas
air gas
Tosei General HospitalNULLComplete: follow-up completeNot applicable75years-oldMale and Female106Not appl1cableJapan
347NCT00786201December 20084/11/2008A 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 FibrosisPulmonary FibrosisDrug: Placebo;Drug: CNTO 888 1 mg/kg;Drug: CNTO 888 5 mg/kg;Drug: CNTO 888 15 mg/kgCentocor, Inc.NULLCompleted40 Years80 YearsBoth126Phase 2United States;Belgium;Canada;Germany;Netherlands
348EUCTR2007-001741-18-NL17/09/200830/05/2008Open-label extension study in patients with Idiopathic Pulmonary Fibrosis who completed protocol AC-052-321 / BUILD 3 - BUILD-3-OLOpen-label extension study in patients with Idiopathic Pulmonary Fibrosis who completed protocol AC-052-321 / BUILD 3 - BUILD-3-OL