85. 特発性間質性肺炎 Idiopathic interstitial pneumonia Clinical trials / Disease details


臨床試験数 : 598 薬物数 : 444 - (DrugBank : 116) / 標的遺伝子数 : 99 - 標的パスウェイ数 : 209

  
85 trials found
No.TrialIDDate_
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PhaseCountries
1NCT05195918
(ClinicalTrials.gov)
April 1, 20222/12/2021Study of Oral Epigallocatechin-3-gallate (EGCG) in IPF PatientsDose Ranging Study of Oral Epigallocatechin-3-gallate (EGCG) Given Daily for 12 Weeks to Patients With Idiopathic Pulmonary Fibrosis (IPF) Evaluating Safety, PK Interactions With Standard of Care Drugs, and Biomarkers of Drug EffectIdiopathic Pulmonary FibrosisCombination Product: EGCG + Nintedanib;Combination Product: EGCG + Pirfenidone;Combination Product: Placebo + Nintedanib or PirfenidoneHal ChapmanUniversity of Michigan;Cornell University;Massachusetts General Hospital;Temple UniversityNot yet recruiting40 Years85 YearsAll50Phase 1United States
2NCT04888715
(ClinicalTrials.gov)
July 23, 202128/4/2021To Evaluate Drug-drug Interactions Between DWN12088 and Pirfenidone or Nintedanib in Healthy VolunteersAn Open Label, 2-part, One-sequence, 3-period Study to Evaluate Drug-drug Interactions Between DWN12088 and Pirfenidone or Nintedanib in Healthy VolunteersIdiopathic Pulmonary FibrosisDrug: DWN12088;Drug: Pirfenidone;Drug: NintedanibDaewoong Pharmaceutical Co. LTD.NULLCompleted19 Years55 YearsAll48Phase 1Korea, Republic of
3EUCTR2020-005103-39-PL
(EUCTR)
24/04/202124/03/2021Access to Pirfenidone Solution for Inhalation (AP01) for Treatment of Progressive, Fibrosing Interstitial Lung Diseases, including Idiopathic Pulmonary FibrosisAccess to Pirfenidone Solution for Inhalation (AP01) for Treatment of Progressive, Fibrosing Interstitial Lung Diseases, including Idiopathic Pulmonary Fibrosis Interstitial Lung Diseases (ILD), including but not limited to idiopathic pulmonary fibrosis (IPF)
MedDRA version: 21.1;Level: PT;Classification code 10022611;Term: Interstitial lung disease;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: Pirfenidone Solution for Inhalation
Product Code: AP01
INN or Proposed INN: PIRFENIDONE
Other descriptive name: NA
Avalyn Pharma, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
100Phase 2Czechia;Czech Republic;Poland;Australia;Netherlands;United Kingdom;New Zealand
4EUCTR2020-005103-39-CZ
(EUCTR)
16/04/202122/12/2020Access to Pirfenidone Solution for Inhalation (AP01) for Treatment of Progressive, Fibrosing Interstitial Lung Diseases, including Idiopathic Pulmonary FibrosisAccess to Pirfenidone Solution for Inhalation (AP01) for Treatment of Progressive, Fibrosing Interstitial Lung Diseases, including Idiopathic Pulmonary Fibrosis Interstitial Lung Diseases (ILD), including but not limited to idiopathic pulmonary fibrosis (IPF)
MedDRA version: 21.1;Level: PT;Classification code 10022611;Term: Interstitial lung disease;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: Pirfenidone Solution for Inhalation
Product Code: AP01
INN or Proposed INN: PIRFENIDONE
Other descriptive name: NA
Avalyn Pharma, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
100Phase 2Czechia;Czech Republic;Poland;Australia;Netherlands;United Kingdom;New Zealand
5JPRN-jRCT2031210008
27/01/202102/04/2021A Clinical Study to Test How Effective and Safe GLPG1690 is for Subjects With Idiopathic Pulmonary Fibrosis (IPF) When Used Together With Standard of CareA Phase 3, Randomized, Double-blind, Parallel-group, Placebo-controlled, Multi-center Study to Evaluate the Efficacy and Safety of Two Doses of GLPG1690 in Addition to Local Standard of Care for Minimum 52 Weeks in Subjects With Idiopathic Pulmonary Fibrosis Idiopathic Pulmonary FibrosisThis clinical Phase 3 study is a randomized, double-blind, parallel-group, placebo-controlled multicenter study designed to evaluate the efficacy and safety of two doses (200 mg q.d. and 600 mg q.d.) of orally administered GLPG1690 in addition to local standard of care for at least 52 weeks in adult subjects with a centrally confirmed diagnosis of IPF. Local standard of care for IPF is defined as receiving either pirfenidone or nintedanib at a stable dose for at least two months before screening, and during screening; or neither pirfenidone or nintedanib (for any reason). A stable dose is defined as the highest dose tolerated by the subject during those two months. A total of approximately 750 subjects with confirmed diagnosis of IPF will be randomized, 250 subjects in each treatment group (GLPG1690 600 mg q.d., GLPG1690200 mg q.d., or matching placebo).Kayamori TakefumiNULLNot Recruiting>= 40age oldNot applicableBoth49Phase 3Japan;USA;Denmark;Peru;Australia;Germany;Taiwan;Belgium;Greece;Brazil;Spain;Chile;United Kingdom;Czech Republic;Turkey
6NCT03939520
(ClinicalTrials.gov)
June 11, 20203/5/2019Management of Progressive Disease in Idiopathic Pulmonary FibrosisPragmatic Management of Progressive Disease in Idiopathic Pulmonary Fibrosis: a Randomized TrialProgressive Idiopathic Pulmonary FibrosisDrug: pirfenidone and nintedanib;Drug: pirfenidone or nintedanibHospices Civils de LyonNULLRecruiting50 YearsN/AAll378Phase 4France
7EUCTR2019-004326-19-FR
(EUCTR)
27/01/202013/11/2019Management 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]
Trade Name: pirfenidone
INN or Proposed INN: PIRFENIDONE
Trade Name: nintedanib
Other descriptive name: NINTEDANIB
Hospices Civils de LyonNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
378 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noFrance
8ChiCTR2000037602
2020-01-012020-08-29Clinical 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;Phase 4China
9NCT03981094
(ClinicalTrials.gov)
May 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
10NCT03958071
(ClinicalTrials.gov)
February 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
11EUCTR2016-003827-45-GR
(EUCTR)
29/05/201816/05/2018AN 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: 20.0;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Trade Name: ESBRIET
Product Name: ESBRIET
INN or Proposed INN: PIRFENIDONE
Other descriptive name: ESBRIET
Trade Name: ESBRIET
Product Name: ESBRIET
INN or Proposed INN: PIRFENIDONE
Other descriptive name: ESBRIET
Trade Name: ESBRIET
Product Name: ESBRIET
INN or Proposed INN: PIRFENIDONE
Other descriptive name: ESBRIET
CIBERES - Instituto Carlos IIIInstitut d'Investigació Biomédica de Bellvitge (IDIBELL)Not RecruitingFemale: yes
Male: yes
90Phase 4Greece;Spain;United Kingdom
12EUCTR2016-003827-45-GB
(EUCTR)
15/05/201801/02/2018AN 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]
Trade Name: ESBRIET
Product Name: ESBRIET
INN or Proposed INN: PIRFENIDONE
Other descriptive name: ESBRIET
Trade Name: ESBRIET
Product Name: ESBRIET
INN or Proposed INN: PIRFENIDONE
Other descriptive name: ESBRIET
Trade Name: ESBRIET
Product Name: ESBRIET
INN or Proposed INN: PIRFENIDONE
Other descriptive name: ESBRIET
CIBER - Instituto Carlos IIIInstitut d'Investigació Biomédica de Bellvitge (IDIBELL)Authorised-recruitment may be ongoing or finished Female: yes
Male: yes
90 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yesGreece;Spain;United Kingdom
13NCT03208933
(ClinicalTrials.gov)
October 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
14JPRN-UMIN000029411
2017/10/1515/10/2017Phase 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
15NCT03115619
(ClinicalTrials.gov)
April 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
16EUCTR2015-005131-40-CZ
(EUCTR)
20/03/201716/12/2016A 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: 20.0;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Trade Name: Esbriet
Product Name: Esbriet
Product Code: RO0220912
INN or Proposed INN: PIRFENIDONE
Trade Name: Sildenafil
Product Name: Sildenafil
Product Code: RO0280296
INN or Proposed INN: SILDENAFIL
F. Hoffmann-La Roche LtdNULLNot RecruitingFemale: yes
Male: yes
176Phase 2United Arab Emirates;Greece;Spain;Turkey;Israel;Italy;Egypt;Czech Republic;Hungary;Canada;Belgium;South Africa;Germany;Netherlands
17EUCTR2015-005131-40-HU
(EUCTR)
16/01/201701/12/2016A 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: 19.0;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Trade Name: Esbriet
Product Name: Esbriet
Product Code: RO0220912
INN or Proposed INN: PIRFENIDONE
Trade Name: Sildenafil
Product Name: Sildenafil
Product Code: RO0280296
INN or Proposed INN: SILDENAFIL
F. Hoffmann-La Roche LtdNULLNot RecruitingFemale: yes
Male: yes
176Phase 2United Arab Emirates;Greece;Spain;Turkey;Israel;Italy;Egypt;Hungary;Czech Republic;Canada;Belgium;South Africa;Netherlands;Germany
18NCT02951429
(ClinicalTrials.gov)
December 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
19EUCTR2015-005131-40-BE
(EUCTR)
16/12/201620/10/2016A 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: 21.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Trade Name: Esbriet
Product Name: Esbriet
Product Code: RO0220912
INN or Proposed INN: PIRFENIDONE
Trade Name: Sildenafil
Product Name: Sildenafil
Product Code: RO0280296
INN or Proposed INN: SILDENAFIL
F. Hoffmann-La Roche LtdNULLNot RecruitingFemale: yes
Male: yes
176Phase 2United Arab Emirates;Greece;Spain;Turkey;Israel;Italy;Egypt;Czech Republic;Hungary;Canada;Belgium;South Africa;Germany;Netherlands
20EUCTR2015-005131-40-DE
(EUCTR)
08/12/201625/10/2016A 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: 21.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Trade Name: Esbriet
Product Name: Esbriet
Product Code: RO0220912
INN or Proposed INN: PIRFENIDONE
Trade Name: Sildenafil
Product Name: Sildenafil
Product Code: RO0280296
INN or Proposed INN: SILDENAFIL
F. Hoffmann-La Roche LtdNULLNot RecruitingFemale: yes
Male: yes
176Phase 2United Arab Emirates;Greece;Spain;Turkey;Israel;Italy;Egypt;Czech Republic;Hungary;Canada;Belgium;South Africa;Germany;Netherlands
21EUCTR2015-005131-40-GR
(EUCTR)
06/12/201603/11/2016A 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: 19.0;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Trade Name: Esbriet
Product Name: Esbriet
Product Code: RO0220912
INN or Proposed INN: PIRFENIDONE
Trade Name: Sildenafil
Product Name: Sildenafil
Product Code: RO0280296
INN or Proposed INN: SILDENAFIL
F. Hoffmann-La Roche LtdNULLNot RecruitingFemale: yes
Male: yes
176Phase 2United Arab Emirates;Greece;Spain;Turkey;Israel;Italy;Egypt;Czech Republic;Hungary;Canada;Belgium;South Africa;Germany;Netherlands
22EUCTR2015-005131-40-NL
(EUCTR)
02/12/201613/10/2016A 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: 20.0;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Trade Name: Esbriet
Product Name: Esbriet
Product Code: RO0220912
INN or Proposed INN: PIRFENIDONE
Trade Name: Sildenafil
Product Name: Sildenafil
Product Code: RO0280296
INN or Proposed INN: SILDENAFIL
F. Hoffmann-La Roche LtdNULLNot RecruitingFemale: yes
Male: yes
176Phase 2United Arab Emirates;Greece;Spain;Turkey;Israel;Italy;Egypt;Czech Republic;Hungary;Canada;Belgium;South Africa;Netherlands;Germany
23EUCTR2015-005131-40-IT
(EUCTR)
09/11/201625/05/2021A Study to Evaluate the Efficacy, Safety, and Tolerability of Sildenafil Added to Pirfenidone in Patients with Advanced Idiopathic Pulmonary Fibrosis and Risk of Pulmonary Hypertension due to the lung disease.A PHASE IIb, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE THE EFFICACY, SAFETY, AND TOLERABILITY OF SILDENAFIL ADDED TO PIRFENIDONE IN PATIENTS WITH ADVANCED IDIOPATHIC PULMONARY FIBROSIS AND RISK OF GROUP 3 PULMONARY HYPERTENSION. - na Pulmonary Hypertension in patients with Idiopathic pulmonary fibrosis (IPF)
MedDRA version: 21.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Trade Name: Esbriet
Product Name: ESBRIET
Product Code: [RO0220912]
INN or Proposed INN: 00322900
Trade Name: Sildenafil
Product Name: sildenafil
Product Code: [G048E03]
INN or Proposed INN: 00258901
F. HOFFMANN - LA ROCHE LTD.NULLNot RecruitingFemale: yes
Male: yes
176Phase 2United Arab Emirates;Czechia;Greece;Spain;Turkey;Israel;Italy;Egypt;Czech Republic;Hungary;Canada;Belgium;South Africa;Germany;Netherlands
24EUCTR2015-005131-40-ES
(EUCTR)
20/10/201609/09/2016A 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: 19.0;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Trade Name: Esbriet
Product Name: Esbriet
Product Code: RO0220912
INN or Proposed INN: PIRFENIDONE
Trade Name: Sildenafil
Product Name: Sildenafil
Product Code: RO0280296
INN or Proposed INN: SILDENAFIL
F. Hoffmann-La Roche 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
25EUCTR2015-003280-11-NL
(EUCTR)
29/04/201619/01/2016A 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: 19.0;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Trade Name: Esbriet
Product Name: Esbriet
Product Code: RO0220912
INN or Proposed INN: PIRFENIDONE
Trade Name: Ofev
Product Name: Ofev
Product Code: 534-1508
INN or Proposed INN: NINTEDANIB
Trade Name: Ofev
Product Name: Ofev
Product Code: 534-1508
INN or Proposed INN: NINTEDANIB
F. Hoffmann-La Roche LtdNULLNot RecruitingFemale: yes
Male: yes
80Phase 4France;United States;Canada;Spain;Denmark;Germany;Netherlands;Italy
26NCT02606877
(ClinicalTrials.gov)
April 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
27EUCTR2015-003280-11-DE
(EUCTR)
25/02/201619/10/2015A 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: 19.0;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Trade Name: Esbriet
Product Name: Esbriet
Product Code: RO0220912
INN or Proposed INN: PIRFENIDONE
Trade Name: Ofev
Product Name: Ofev
Product Code: 534-1508
INN or Proposed INN: NINTEDANIB
Trade Name: Ofev
Product Name: Ofev
Product Code: 534-1508
INN or Proposed INN: NINTEDANIB
F. Hoffmann-La Roche LtdNULLNot RecruitingFemale: yes
Male: yes
80Phase 4France;United States;Canada;Spain;Denmark;Netherlands;Germany;Italy
28JPRN-UMIN000020682
2016/01/2222/01/2016The comparison of the efficacy and safety of pirfenidone and nintedanib in patients with idiopathic pulmonary fibrosisThe comparison of the efficacy and safety of pirfenidone and nintedanib in patients with idiopathic pulmonary fibrosis - The comparison of antifibrotic agents in patients with idiopathic pulmonary fibrosis Idiopathic pulmonary 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 applicableJapan
29EUCTR2015-003280-11-DK
(EUCTR)
20/01/201625/11/2015A 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: 19.0;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Trade Name: Esbriet
Product Name: Esbriet
Product Code: RO0220912
INN or Proposed INN: PIRFENIDONE
Trade Name: Ofev
Product Name: Ofev
Product Code: 534-1508
INN or Proposed INN: NINTEDANIB
Trade Name: Ofev
Product Name: Ofev
Product Code: 534-1508
INN or Proposed INN: NINTEDANIB
F. Hoffmann-La Roche LtdNULLNot RecruitingFemale: yes
Male: yes
80Phase 4France;United States;Canada;Spain;Denmark;Netherlands;Germany;Italy
30NCT02648048
(ClinicalTrials.gov)
January 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
31NCT02598193
(ClinicalTrials.gov)
January 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
32EUCTR2015-000640-42-IT
(EUCTR)
22/12/201522/02/2018Safety, 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: 20.0;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Trade Name: Ofev
INN or Proposed INN: nintedanib
Other descriptive name: nintedanib
Trade Name: Ofev
INN or Proposed INN: Nintedanib
Other descriptive name: NINTEDANIB
Trade Name: Esbriet
INN or Proposed INN: PIRFENIDONE
Other descriptive name: PIRFENIDONE
BOEHRINGER-INGELHEIM ITALIA S.P.A.NULLNot RecruitingFemale: yes
Male: yes
135Phase 4France;United States;Canada;Netherlands;Germany;Italy
33EUCTR2015-003280-11-IT
(EUCTR)
17/12/201527/05/2021A 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 - NA Idiopathic Pulmonary Fibrosis (IPF)
MedDRA version: 21.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Trade Name: ESBRIET - 267 MG - CAPSULA RIGIDA - USO ORALE - FLACONE (HDPE) 270 CAPSULE
Product Name: Esbriet
Product Code: RO0220912
INN or Proposed INN: PIRFENIDONE
Trade Name: Ofev
INN or Proposed INN: NINTEDANIB
Trade Name: Ofev
INN or Proposed INN: NINTEDANIB
F. HOFFMANN - LA ROCHE LTD.NULLNot RecruitingFemale: yes
Male: yes
80Phase 4France;United States;Canada;Spain;Denmark;Netherlands;Germany;Italy
34EUCTR2015-003280-11-ES
(EUCTR)
16/12/201530/10/2015A 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: 18.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Trade Name: Esbriet
Product Name: Esbriet
Product Code: RO0220912
INN or Proposed INN: PIRFENIDONE
Trade Name: Ofev
Product Name: Ofev
Product Code: 534-1508
INN or Proposed INN: NINTEDANIB
Trade Name: Ofev
Product Name: Ofev
Product Code: 534-1508
INN or Proposed INN: NINTEDANIB
Roche Farma S.A., que representa en España a F. Hoffmann-La Roche LtdNULLNot RecruitingFemale: yes
Male: yes
80Phase 4France;United States;Canada;Spain;Denmark;Netherlands;Germany;Italy
35EUCTR2014-000861-32-DE
(EUCTR)
01/12/201502/09/2015Standard-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: 20.0;Level: LLT;Classification code 10022612;Term: Interstitial lung fibrosis;System Organ Class: 100000004855
MedDRA version: 20.0;Classification code 10035754;Term: Pneumonitis hypersensitivity;Classification code 10025088;Term: Lung fibrosis;Classification code 10022617;Term: Interstitial pneumonia;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Trade Name: Esbriet® (Pirfenidon)
Product Name: Esbriet® (Pirfenidon)
Product Code: PZN 8881655(RochePharma AG)
INN or Proposed INN: PIRFENIDONE
Justus Liebig Universität GiessenNULLNot RecruitingFemale: yes
Male: yes
374Phase 2Germany
36EUCTR2015-000640-42-DE
(EUCTR)
01/12/201503/09/2015Safety, 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: 19.0;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Trade Name: Ofev
Product Name: Ofev 100 mg capsule
Product Code: nintedanib
INN or Proposed INN: nintedanib
Other descriptive name: NINTEDANIB
Trade Name: Ofev
Product Name: Ofev 150 mg capsule
Product Code: nintedanib
INN or Proposed INN: nintedanib
Other descriptive name: NINTEDANIB
Trade Name: Esbriet
Product Name: pirfenidone
Product Code: pirfenidone
INN or Proposed INN: PIRFENIDONE
Other descriptive name: PIRFENIDONE
Boehringer Ingelheim Pharma GmbH & Co.KGNULLNot RecruitingFemale: yes
Male: yes
135Phase 4France;United States;Canada;Netherlands;Germany;Italy
37NCT02579603
(ClinicalTrials.gov)
October 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
38JPRN-UMIN000019436
2015/10/1621/10/2015Randomized 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
39EUCTR2015-000640-42-NL
(EUCTR)
13/10/201518/08/2015Safety, 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: 18.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Trade Name: Ofev
Product Name: Ofev 100 mg capsule
Product Code: nintedanib
INN or Proposed INN: nintedanib
Other descriptive name: NINTEDANIB
Trade Name: Ofev
Product Name: Ofev 150 mg capsule
Product Code: nintedanib
INN or Proposed INN: nintedanib
Other descriptive name: NINTEDANIB
Trade Name: Esbriet
Product Name: pirfenidone
Product Code: pirfenidone
INN or Proposed INN: PIRFENIDONE
Other descriptive name: PIRFENIDONE
Boehringer Ingelheim bvNULLNot RecruitingFemale: yes
Male: yes
135Phase 4France;United States;Canada;Germany;Netherlands;Italy
40EUCTR2015-000640-42-FR
(EUCTR)
26/08/201505/08/2015Safety, 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: 18.0;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Trade Name: Ofev
Product Name: Ofev 100 mg capsule
Product Code: nintedanib
INN or Proposed INN: nintedanib
Other descriptive name: NINTEDANIB
Trade Name: Ofev
Product Name: Ofev 150 mg capsule
Product Code: nintedanib
INN or Proposed INN: nintedanib
Other descriptive name: NINTEDANIB
Trade Name: Esbriet
Product Name: pirfenidone
Product Code: pirfenidone
INN or Proposed INN: PIRFENIDONE
Other descriptive name: PIRFENIDONE
Boehringer Ingelheim FranceNULLNot RecruitingFemale: yes
Male: yes
135Phase 4United States;France;Canada;Netherlands;Germany;Italy
41JPRN-UMIN000016826
2015/03/3131/03/2015The 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 applicableJapan
42JPRN-UMIN000015508
2015/01/0124/10/2014A 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
43NCT02141087
(ClinicalTrials.gov)
July 201415/5/2014Expanded Access Program (EAP): Allow Patients in the US With Idiopathic Pulmonary Fibrosis Access to PirfenidoneA Treatment Protocol to Allow Patients in the US With Idiopathic Pulmonary Fibrosis Access to PirfenidoneIdiopathic Pulmonary FibrosisDrug: PirfenidoneGenentech, Inc.NULLApproved for marketing18 YearsN/ABothN/ANULL
44NCT02622477
(ClinicalTrials.gov)
June 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
45EUCTR2013-001163-24-BE
(EUCTR)
28/04/201410/02/2014A 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
46NCT02009293
(ClinicalTrials.gov)
December 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
47EUCTR2013-001163-24-PL
(EUCTR)
09/11/201301/10/2013A 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
48EUCTR2013-001163-24-DE
(EUCTR)
04/11/201328/08/2013A 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
49EUCTR2013-001163-24-GB
(EUCTR)
14/10/201306/11/2013A 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]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 Recruiting Female: yes
Male: yes
480 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noUnited States;Spain;United Kingdom;Italy;France;Mexico;Canada;Belgium;Poland;Australia;Peru;Germany;Japan
50NCT01872689
(ClinicalTrials.gov)
October 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
51EUCTR2012-000564-14-GB
(EUCTR)
11/09/201304/07/2013 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]
Trade Name: Fluimucil® 600 mg effervescent tablets
INN or Proposed INN: ACETYLCYSTEINE
Other descriptive name: N-Acetylcysteine, (NAC)
InterMune International AG.NULLNot Recruiting Female: yes
Male: yes
120 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noBelgium;Denmark;Austria;Germany;Italy;United Kingdom;Sweden
52EUCTR2012-000564-14-DK
(EUCTR)
28/08/201312/07/2013A 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: 17.0;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Trade Name: Fluimucil® 600 mg effervescent tablets
INN or Proposed INN: ACETYLCYSTEINE
Other descriptive name: N-Acetylcysteine, (NAC)
InterMune International AG.NULLNot RecruitingFemale: yes
Male: yes
120Phase 2Belgium;Austria;Denmark;Germany;United Kingdom;Italy;Sweden
53NCT02707640
(ClinicalTrials.gov)
August 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
54NCT01890265
(ClinicalTrials.gov)
July 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
55EUCTR2012-000564-14-AT
(EUCTR)
19/07/201311/06/2013A 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: 17.0;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Trade Name: Fluimucil® 600 mg effervescent tablets
INN or Proposed INN: ACETYLCYSTEINE
Other descriptive name: N-Acetylcysteine, (NAC)
InterMune International AG.NULLNot RecruitingFemale: yes
Male: yes
120Phase 2Sweden;Italy;United Kingdom;Germany;Austria;Denmark;Belgium
56EUCTR2012-000564-14-IT
(EUCTR)
17/07/201307/06/2013A 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: 16.0;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Trade Name: Fluimucil® 600 mg effervescent tablets
INN or Proposed INN: ACETYLCYSTEINE
Other descriptive name: N-Acetylcysteine, (NAC)
InterMune International AG.NULLNot RecruitingFemale: yes
Male: yes
250Phase 2Belgium;Denmark;Austria;Germany;United Kingdom;Italy;Sweden
57EUCTR2012-000564-14-DE
(EUCTR)
17/07/201329/05/2013A 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: 17.0;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Trade Name: Fluimucil® 600 mg effervescent tablets
INN or Proposed INN: ACETYLCYSTEINE
Other descriptive name: N-Acetylcysteine, (NAC)
InterMune International AG.NULLNot RecruitingFemale: yes
Male: yes
120Phase 2Belgium;Denmark;Austria;Germany;United Kingdom;Italy;Sweden
58EUCTR2012-000564-14-SE
(EUCTR)
25/06/201324/05/2013A 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: 17.0;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Trade Name: Fluimucil® 600 mg effervescent tablets
INN or Proposed INN: ACETYLCYSTEINE
Other descriptive name: N-Acetylcysteine, (NAC)
InterMune International AG.NULLNot RecruitingFemale: yes
Male: yes
120Phase 2Belgium;Denmark;Austria;Germany;United Kingdom;Italy;Sweden
59EUCTR2012-000564-14-BE
(EUCTR)
18/06/201330/04/2013A 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: 17.0;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Trade Name: Fluimucil® 600 mg effervescent tablets
INN or Proposed INN: ACETYLCYSTEINE
Other descriptive name: N-Acetylcysteine, (NAC)
InterMune International AG.NULLNot RecruitingFemale: yes
Male: yes
120Phase 2Belgium;Denmark;Austria;Germany;United Kingdom;Italy;Sweden
60JPRN-UMIN000008541
2012/07/3030/07/2012The 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 applicableJapan
61JPRN-UMIN000007774
2012/06/0116/04/2012Phase 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
62NCT02699879
(ClinicalTrials.gov)
February 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
63NCT01504334
(ClinicalTrials.gov)
January 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
64NCT02136992
(ClinicalTrials.gov)
December 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
65NCT01417156
(ClinicalTrials.gov)
September 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
66NCT01366209
(ClinicalTrials.gov)
June 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
67NCT01136174
(ClinicalTrials.gov)
May 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
68JPRN-UMIN000005793
2009/11/0116/06/2011Open-label study of tiotropium/pirfenidone for idiopathic pulmonary fibrosis with emphysema Idiopathic pulmonary fibrosis (IPF) with centrilobular emphysema (CLE)tiotropium for 8 weeks and then
tiotropium + pirfenidone for 44 weeks
pirfenidone 44 weeks and then
tiotropium + pirfenidone for 8 weeks
Saitama Medical UniversityNULLRecruiting40years-oldNot applicableMale and Female60Not selectedJapan
69JPRN-UMIN000016045
2009/10/0326/12/2014A 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
70NCT00662038
(ClinicalTrials.gov)
August 200817/4/2008Open-Label Study of the Long Term Safety of Pirfenidone in Patients With Idiopathic Pulmonary Fibrosis (IPF)An Open-Label Extension Study of the Long Term Safety of Pirfenidone in Patients With Idiopathic Pulmonary Fibrosis (IPF)Idiopathic Pulmonary FibrosisDrug: pirfenidoneGenentech, Inc.Hoffmann-La RocheCompleted40 Years84 YearsAll1058Phase 3United States
71EUCTR2007-007800-13-IT
(EUCTR)
11/06/200802/10/2008Studio di estensione in aperto sulla sicurezza a lungo termine del pirfenidone nei pazienti con fibrosi polmonare idiopatica (FPI) che hanno completato gli studi CAPACITY - NDStudio di estensione in aperto sulla sicurezza a lungo termine del pirfenidone nei pazienti con fibrosi polmonare idiopatica (FPI) che hanno completato gli studi CAPACITY - ND Idiopathic Pulmonary Fibrosis (IPF)
MedDRA version: 9.1;Level: LLT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis
Product Name: PirfenidoneINTERMUNENULLNot RecruitingFemale: yes
Male: yes
750Germany;United Kingdom;Belgium;France;Spain;Ireland;Italy
72EUCTR2007-007800-13-IE
(EUCTR)
04/06/200807/02/2008An Open-Label Extension Study of the Long-Term Safety of Pirfenidone in Patients with Idiopathic Pulmonary Fibrosis (IPF) Who Complete the CAPACITY Studies - Open-Label Extension of Pirfenidone CAPACITY StudiesAn Open-Label Extension Study of the Long-Term Safety of Pirfenidone in Patients with Idiopathic Pulmonary Fibrosis (IPF) Who Complete the CAPACITY Studies - Open-Label Extension of Pirfenidone CAPACITY Studies Idiopathic Pulmonary Fibrosis (IPF)
MedDRA version: 9.1;Level: LLT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis
Product Name: Pirfenidone
INN or Proposed INN: Pirfenidone
Other descriptive name: PIR, S-7701
InterMune, Inc.NULLNot RecruitingFemale: yes
Male: yes
750Phase 3France;Belgium;Germany;Italy;United Kingdom;Ireland;Spain
73EUCTR2007-007800-13-GB
(EUCTR)
03/06/200808/02/2008Open-Label Extension of Pirfenidone CAPACITY StudiesAn Open-Label Extension Study of the Long-Term Safety of Pirfenidone in Patients with Idiopathic Pulmonary Fibrosis (IPF) Who Complete the CAPACITY Studies - Open-Label Extension of Pirfenidone CAPACITY Studies Idiopathic Pulmonary Fibrosis (IPF)
MedDRA version: 14.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders ;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: Pirfenidone
INN or Proposed INN: Pirfenidone
Other descriptive name: PIR, S-7701
InterMune, Inc.NULLNot Recruiting Female: yes
Male: yes
600 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noFrance;United States;Canada;Belgium;Spain;Poland;Ireland;Australia;Germany;Italy;United Kingdom
74EUCTR2007-007800-13-ES
(EUCTR)
26/05/200801/04/2008An Open-Label Extension Study of the Long-Term Safety of Pirfenidone in Patients with Idiopathic Pulmonary Fibrosis (IPF) Who Complete the CAPACITY StudiesEstudio de extensión de etiqueta abierta de la seguridad a largo plazo de pirfenidona en pacientes con fibrosis pulmonar idiopática (FPI) que completan los estudios CAPACITY. - Open-Label Extension of Pirfenidone CAPACITY StudiesAn Open-Label Extension Study of the Long-Term Safety of Pirfenidone in Patients with Idiopathic Pulmonary Fibrosis (IPF) Who Complete the CAPACITY StudiesEstudio de extensión de etiqueta abierta de la seguridad a largo plazo de pirfenidona en pacientes con fibrosis pulmonar idiopática (FPI) que completan los estudios CAPACITY. - Open-Label Extension of Pirfenidone CAPACITY Studies Idiopathic Pulmonary Fibrosis (IPF)Fibrosis pulmonar idiopática
MedDRA version: 9.1;Level: LLT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis
Product Name: Pirfenidone
INN or Proposed INN: Pirfenidone
Other descriptive name: PIR, S-7701
InterMune, Inc.NULLNot RecruitingFemale: yes
Male: yes
750Phase 3France;Belgium;Spain;Ireland;Germany;Italy;United Kingdom
75EUCTR2007-007800-13-DE
(EUCTR)
23/05/200821/02/2008An Open-Label Extension Study of the Long-Term Safety of Pirfenidone in Patients with Idiopathic Pulmonary Fibrosis (IPF) Who Complete the CAPACITY Studies - Open-Label Extension of Pirfenidone CAPACITY StudiesAn Open-Label Extension Study of the Long-Term Safety of Pirfenidone in Patients with Idiopathic Pulmonary Fibrosis (IPF) Who Complete the CAPACITY Studies - Open-Label Extension of Pirfenidone CAPACITY Studies Idiopathic Pulmonary Fibrosis (IPF)
MedDRA version: 9.1;Level: LLT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis
Product Name: Pirfenidone
INN or Proposed INN: Pirfenidone
Other descriptive name: PIR, S-7701
InterMune, Inc.NULLNot RecruitingFemale: yes
Male: yes
750Phase 3France;Spain;Belgium;Ireland;Germany;Italy;United Kingdom
76EUCTR2007-007800-13-BE
(EUCTR)
15/05/200826/03/2008An Open-Label Extension Study of the Long-Term Safety of Pirfenidone in Patients with Idiopathic Pulmonary Fibrosis (IPF) Who Complete the CAPACITY Studies - Open-Label Extension of Pirfenidone CAPACITY StudiesAn Open-Label Extension Study of the Long-Term Safety of Pirfenidone in Patients with Idiopathic Pulmonary Fibrosis (IPF) Who Complete the CAPACITY Studies - Open-Label Extension of Pirfenidone CAPACITY Studies Idiopathic Pulmonary Fibrosis (IPF)
MedDRA version: 9.1;Level: LLT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis
Product Name: Pirfenidone
INN or Proposed INN: Pirfenidone
Other descriptive name: PIR, S-7701
InterMune, Inc.NULLNot RecruitingFemale: yes
Male: yes
750France;Spain;Belgium;Ireland;Germany;Italy;United Kingdom
77EUCTR2007-007800-13-FR
(EUCTR)
13/05/200829/02/2008An Open-Label Extension Study of the Long-Term Safety of Pirfenidone in Patients with Idiopathic Pulmonary Fibrosis (IPF) Who Complete the CAPACITY Studies - Open-Label Extension of Pirfenidone CAPACITY StudiesAn Open-Label Extension Study of the Long-Term Safety of Pirfenidone in Patients with Idiopathic Pulmonary Fibrosis (IPF) Who Complete the CAPACITY Studies - Open-Label Extension of Pirfenidone CAPACITY Studies Idiopathic Pulmonary Fibrosis (IPF)
MedDRA version: 9.1;Level: LLT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis
Product Name: Pirfenidone
INN or Proposed INN: Pirfenidone
InterMune, Inc.NULLNot RecruitingFemale: yes
Male: yes
750France;Spain;Belgium;Ireland;Germany;Italy;United Kingdom
78EUCTR2006-000138-11-ES
(EUCTR)
31/07/200618/05/2006A Randomised, Double-Blind, Placebo-Controlled, Phase 3 Study of the Safety and Efficacy of Pirfenidone in Patients with Idiopathic Pulmonary FibrosisEstudio aleatorio, a doble ciego, controlado con placebo, de fase 3 sobre la seguridad y eficacia de Pirfenidona en pacientes con fibrosis pulmonar idiopáticaA Randomised, Double-Blind, Placebo-Controlled, Phase 3 Study of the Safety and Efficacy of Pirfenidone in Patients with Idiopathic Pulmonary FibrosisEstudio aleatorio, a doble ciego, controlado con placebo, de fase 3 sobre la seguridad y eficacia de Pirfenidona en pacientes con fibrosis pulmonar idiopática Idiopathic Pulmonary Fibrosis (IPF)Fibrosis Pulmonar IdiopáticaProduct Name: Pirfenidone
INN or Proposed INN: Pirfenidone
InterMune, Inc.NULLNot RecruitingFemale: yes
Male: yes
260Phase 3Czech Republic;Belgium;Spain;Ireland;Germany
79NCT00287716
(ClinicalTrials.gov)
July 14, 20066/2/2006Three-Arm Study of the Safety and Efficacy of Pirfenidone in Patients With Idiopathic Pulmonary FibrosisA Randomized, Double-Blind, Placebo Controlled, Phase 3, Three-Arm Study of the Safety and Efficacy of Pirfenidone in Patients With Idiopathic Pulmonary FibrosisIdiopathic Pulmonary FibrosisDrug: Pirfenidone;Drug: PlaceboGenentech, Inc.NULLCompleted40 Years80 YearsAll435Phase 3United States
80EUCTR2006-000252-41-GB
(EUCTR)
29/06/200611/04/2006A Randomized, Double-Blind, Placebo Controlled, Phase 3 Three-Arm Study of the Safety and Efficacy of Pirfenidone in Patients with Idiopathic Pulmonary FibrosisA Randomized, Double-Blind, Placebo Controlled, Phase 3 Three-Arm Study of the Safety and Efficacy of Pirfenidone in Patients with Idiopathic Pulmonary Fibrosis Idiopathic Pulmonary Fibrosis (IPF)
MedDRA version: 9.1;Level: LLT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis
Product Name: Pirfenidone
INN or Proposed INN: Pirfenidone
Product Name: Pirfenidone
INN or Proposed INN: Pirfenidone
InterMune, Inc.NULLNot Recruiting Female: yes
Male: yes
325 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noItaly;United Kingdom
81EUCTR2006-000138-11-DE
(EUCTR)
29/06/200616/02/2006A Randomised, Double-Blind, Placebo-Controlled, Phase 3 Study of the Safety and Efficacy of Pirfenidone in Patients with Idiopathic Pulmonary FibrosisA Randomised, Double-Blind, Placebo-Controlled, Phase 3 Study of the Safety and Efficacy of Pirfenidone in Patients with Idiopathic Pulmonary Fibrosis Idiopathic Pulmonary Fibrosis (IPF)
MedDRA version: 9.1;Level: LLT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis
Product Name: Pirfenidone
INN or Proposed INN: Pirfenidone
InterMune, Inc.NULLNot RecruitingFemale: yes
Male: yes
260Phase 3Czech Republic;Germany;Belgium;Spain;Ireland
82EUCTR2006-000138-11-BE
(EUCTR)
27/06/200610/03/2006A Randomised, Double-Blind, Placebo-Controlled, Phase 3 Study of the Safety and Efficacy of Pirfenidone in Patients with Idiopathic Pulmonary FibrosisA Randomised, Double-Blind, Placebo-Controlled, Phase 3 Study of the Safety and Efficacy of Pirfenidone in Patients with Idiopathic Pulmonary Fibrosis Idiopathic Pulmonary Fibrosis (IPF)
MedDRA version: 9.1;Level: LLT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis
Product Name: Pirfenidone
INN or Proposed INN: Pirfenidone
InterMune, Inc.NULLNot RecruitingFemale: yes
Male: yes
260Phase 3Czech Republic;Germany;Belgium;Spain;Ireland
83EUCTR2006-000138-11-CZ
(EUCTR)
25/05/200606/04/2006A Randomised, Double-Blind, Placebo-Controlled, Phase 3 Study of the Safety and Efficacy of Pirfenidone in Patients with Idiopathic Pulmonary FibrosisA Randomised, Double-Blind, Placebo-Controlled, Phase 3 Study of the Safety and Efficacy of Pirfenidone in Patients with Idiopathic Pulmonary Fibrosis Idiopathic Pulmonary Fibrosis (IPF)Product Name: Pirfenidone
INN or Proposed INN: Pirfenidone
InterMune, Inc.NULLNot RecruitingFemale: yes
Male: yes
260Phase 3Germany;Czech Republic;Belgium;Spain;Ireland
84NCT00287729
(ClinicalTrials.gov)
April 20066/2/2006Safety and Efficacy of Pirfenidone in Patients With Idiopathic Pulmonary FibrosisA Randomized, Double-Blind, Placebo Controlled, Phase 3 Study of the Safety and Efficacy of Pirfenidone in Patients With Idiopathic Pulmonary FibrosisIdiopathic Pulmonary FibrosisDrug: Pirfenidone;Drug: PlaceboGenentech, Inc.NULLCompleted40 Years80 YearsAll344Phase 3United States
85NCT00080223
(ClinicalTrials.gov)
August 31, 200324/3/2004Safety Study of Oral Pirfenidone in Patients With Pulmonary Fibrosis/Idiopathic Pulmonary FibrosisAn Open-Label, Phase 2 Study of the Safety of Oral Pirfenidone in Patients With Pulmonary Fibrosis/Idiopathic Pulmonary FibrosisIdiopathic Pulmonary Fibrosis;Pulmonary FibrosisDrug: PirfenidoneGenentech, Inc.NULLCompleted40 Years85 YearsAll83Phase 2United States