85. 特発性間質性肺炎 Idiopathic interstitial pneumonia Clinical trials / Disease details
臨床試験数 : 627 / 薬物数 : 443 - (DrugBank : 120) / 標的遺伝子数 : 99 - 標的パスウェイ数 : 212
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | NCT05428150 (ClinicalTrials.gov) | August 8, 2022 | 15/6/2022 | Randomized, Crossover, Multi-Dose Pharmacokinetics of EXCL-100 Pirfenidone-Sustained Release Tablet and Esbriet in Healthy Volunteers | Randomized, Crossover, Multi-Dose, Steady State, Comparative Pharmacokinetics and Relative Bioavailability Study of EXCL-100 Pirfenidone-Sustained Release Tablet (EXCL-100), and Esbriet® in Healthy Volunteers | Idiopathic Pulmonary Fibrosis | Drug: Esbriet 267 MG Oral Capsule;Drug: EXCL-100, 600 MG Oral Tablet | Excalibur Pharmaceuticals, Inc. | NULL | Completed | 18 Years | 65 Years | All | 32 | Phase 1 | United States |
| 2 | EUCTR2016-003827-45-GR (EUCTR) | 29/05/2018 | 16/05/2018 | AN OPEN LABEL PHASE IV, MULTICENTER, INTERNATIONAL, INTERVENTIONAL STUDY TO EVALUATE THE EFFECT OF DIET ON GASTROINTESTINAL ADVERSE EVENTS IN PATIENTS WITH IPF TREATED WITH PIRFENIDONE | AN OPEN LABEL PHASE IV, MULTICENTER, INTERNATIONAL, INTERVENTIONAL STUDY TO EVALUATE THE EFFECT OF DIET ON GASTROINTESTINAL ADVERSE EVENTS IN PATIENTS WITH IPF TREATED WITH PIRFENIDONE - MADIET | Idiopathic Pulmonary Fibrosis MedDRA version: 20.0;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Trade Name: ESBRIET Product Name: ESBRIET INN or Proposed INN: PIRFENIDONE Other descriptive name: ESBRIET Trade Name: ESBRIET Product Name: ESBRIET INN or Proposed INN: PIRFENIDONE Other descriptive name: ESBRIET Trade Name: ESBRIET Product Name: ESBRIET INN or Proposed INN: PIRFENIDONE Other descriptive name: ESBRIET | CIBERES - Instituto Carlos III | Institut d'Investigació Biomédica de Bellvitge (IDIBELL) | Not Recruiting | Female: yes Male: yes | 90 | Phase 4 | Greece;Spain;United Kingdom | ||
| 3 | EUCTR2016-003827-45-GB (EUCTR) | 15/05/2018 | 01/02/2018 | AN OPEN LABEL PHASE IV, MULTICENTER, INTERNATIONAL, INTERVENTIONAL STUDY TO EVALUATE THE EFFECT OF DIET ON GASTROINTESTINAL ADVERSE EVENTS IN PATIENTS WITH IPF TREATED WITH PIRFENIDONE | AN OPEN LABEL PHASE IV, MULTICENTER, INTERNATIONAL, INTERVENTIONAL STUDY TO EVALUATE THE EFFECT OF DIET ON GASTROINTESTINAL ADVERSE EVENTS IN PATIENTS WITH IPF TREATED WITH PIRFENIDONE - MADIET (version 1.6) | Idiopathic Pulmonary Fibrosis MedDRA version: 20.0;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders ;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Trade Name: ESBRIET Product Name: ESBRIET INN or Proposed INN: PIRFENIDONE Other descriptive name: ESBRIET Trade Name: ESBRIET Product Name: ESBRIET INN or Proposed INN: PIRFENIDONE Other descriptive name: ESBRIET Trade Name: ESBRIET Product Name: ESBRIET INN or Proposed INN: PIRFENIDONE Other descriptive name: ESBRIET | CIBER - Instituto Carlos III | Institut d'Investigació Biomédica de Bellvitge (IDIBELL) | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 90 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yes | Greece;Spain;United Kingdom | ||
| 4 | EUCTR2015-005131-40-CZ (EUCTR) | 20/03/2017 | 16/12/2016 | A Study to Evaluate the Efficacy, Safety, and Tolerability of Sildenafil Added to Pirfenidone in Patients with Advanced Idiopathic Pulmonary Fibrosis and Risk of Pulmonary Hypertension due to the lung disease. | A PHASE IIb, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE THE EFFICACY, SAFETY, AND TOLERABILITY OF SILDENAFIL ADDED TO PIRFENIDONE IN PATIENTS WITH ADVANCED IDIOPATHIC PULMONARY FIBROSIS AND RISK OF GROUP 3 PULMONARY HYPERTENSION. | Pulmonary Hypertension in patients with Idiopathic pulmonary fibrosis (IPF) MedDRA version: 20.0;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Trade Name: Esbriet Product Name: Esbriet Product Code: RO0220912 INN or Proposed INN: PIRFENIDONE Trade Name: Sildenafil Product Name: Sildenafil Product Code: RO0280296 INN or Proposed INN: SILDENAFIL | F. Hoffmann-La Roche Ltd | NULL | Not Recruiting | Female: yes Male: yes | 176 | Phase 2 | United Arab Emirates;Greece;Spain;Turkey;Israel;Italy;Egypt;Czech Republic;Hungary;Canada;Belgium;South Africa;Germany;Netherlands | ||
| 5 | EUCTR2015-005131-40-HU (EUCTR) | 16/01/2017 | 01/12/2016 | A Study to Evaluate the Efficacy, Safety, and Tolerability of Sildenafil Added to Pirfenidone in Patients with Advanced Idiopathic Pulmonary Fibrosis and Intermediate or High Probability of Pulmonary Hypertension due to the lung disease. | A PHASE IIb, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE THE EFFICACY, SAFETY, AND TOLERABILITY OF SILDENAFIL ADDED TO PIRFENIDONE IN PATIENTS WITH ADVANCED IDIOPATHIC PULMONARY FIBROSIS AND INTERMEDIATE OR HIGH PROBABILITY OF GROUP 3 PULMONARY HYPERTENSION. | Pulmonary Hypertension in patients with Idiopathic pulmonary fibrosis (IPF) MedDRA version: 19.0;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Trade Name: Esbriet Product Name: Esbriet Product Code: RO0220912 INN or Proposed INN: PIRFENIDONE Trade Name: Sildenafil Product Name: Sildenafil Product Code: RO0280296 INN or Proposed INN: SILDENAFIL | F. Hoffmann-La Roche Ltd | NULL | Not Recruiting | Female: yes Male: yes | 176 | Phase 2 | United Arab Emirates;Greece;Spain;Turkey;Israel;Italy;Egypt;Hungary;Czech Republic;Canada;Belgium;South Africa;Netherlands;Germany | ||
| 6 | EUCTR2015-005131-40-BE (EUCTR) | 16/12/2016 | 20/10/2016 | A Study to Evaluate the Efficacy, Safety, and Tolerability of Sildenafil Added to Pirfenidone in Patients with Advanced Idiopathic Pulmonary Fibrosis and Risk of Pulmonary Hypertension due to the lung disease. | A PHASE IIb, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE THE EFFICACY, SAFETY, AND TOLERABILITY OF SILDENAFIL ADDED TO PIRFENIDONE IN PATIENTS WITH ADVANCED IDIOPATHIC PULMONARY FIBROSIS AND RISK OF GROUP 3 PULMONARY HYPERTENSION. | Pulmonary Hypertension in patients with Idiopathic pulmonary fibrosis (IPF) MedDRA version: 21.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Trade Name: Esbriet Product Name: Esbriet Product Code: RO0220912 INN or Proposed INN: PIRFENIDONE Trade Name: Sildenafil Product Name: Sildenafil Product Code: RO0280296 INN or Proposed INN: SILDENAFIL | F. Hoffmann-La Roche Ltd | NULL | Not Recruiting | Female: yes Male: yes | 176 | Phase 2 | United Arab Emirates;Greece;Spain;Turkey;Israel;Italy;Egypt;Czech Republic;Hungary;Canada;Belgium;South Africa;Germany;Netherlands | ||
| 7 | EUCTR2015-005131-40-DE (EUCTR) | 08/12/2016 | 25/10/2016 | A Study to Evaluate the Efficacy, Safety, and Tolerability of Sildenafil Addedto Pirfenidone in Patients with Advanced Idiopathic Pulmonary Fibrosis andRisk of Pulmonary Hypertension due to the lung disease. | A PHASE IIb, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBOCONTROLLEDSTUDY TO EVALUATE THE EFFICACY, SAFETY, AND TOLERABILITY OF SILDENAFIL ADDED TO PIRFENIDONE IN PATIENTSWITH ADVANCED IDIOPATHIC PULMONARY FIBROSIS AND RISK OF GROUP 3 PULMONARY HYPERTENSION. | Pulmonary Hypertension in patients with Idiopathic pulmonary fibrosis (IPF) MedDRA version: 21.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Trade Name: Esbriet Product Name: Esbriet Product Code: RO0220912 INN or Proposed INN: PIRFENIDONE Trade Name: Sildenafil Product Name: Sildenafil Product Code: RO0280296 INN or Proposed INN: SILDENAFIL | F. Hoffmann-La Roche Ltd | NULL | Not Recruiting | Female: yes Male: yes | 176 | Phase 2 | United Arab Emirates;Greece;Spain;Turkey;Israel;Italy;Egypt;Czech Republic;Hungary;Canada;Belgium;South Africa;Germany;Netherlands | ||
| 8 | EUCTR2015-005131-40-GR (EUCTR) | 06/12/2016 | 03/11/2016 | A Study to Evaluate the Efficacy, Safety, and Tolerability of Sildenafil Added to Pirfenidone in Patients with Advanced Idiopathic Pulmonary Fibrosis and Intermediate or High Probability of Pulmonary Hypertension due to the lung disease. | A PHASE IIb, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE THE EFFICACY, SAFETY, AND TOLERABILITY OF SILDENAFIL ADDED TO PIRFENIDONE IN PATIENTS WITH ADVANCED IDIOPATHIC PULMONARY FIBROSIS AND INTERMEDIATE OR HIGH PROBABILITY OF GROUP 3 PULMONARY HYPERTENSION. | Pulmonary Hypertension in patients with Idiopathic pulmonary fibrosis (IPF) MedDRA version: 19.0;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Trade Name: Esbriet Product Name: Esbriet Product Code: RO0220912 INN or Proposed INN: PIRFENIDONE Trade Name: Sildenafil Product Name: Sildenafil Product Code: RO0280296 INN or Proposed INN: SILDENAFIL | F. Hoffmann-La Roche Ltd | NULL | Not Recruiting | Female: yes Male: yes | 176 | Phase 2 | United Arab Emirates;Greece;Spain;Turkey;Israel;Italy;Egypt;Czech Republic;Hungary;Canada;Belgium;South Africa;Germany;Netherlands | ||
| 9 | EUCTR2015-005131-40-NL (EUCTR) | 02/12/2016 | 13/10/2016 | A Study to Evaluate the Efficacy, Safety, and Tolerability of Sildenafil Added to Pirfenidone in Patients with Advanced Idiopathic Pulmonary Fibrosis and Risk of Pulmonary Hypertension due to the lung disease. | A PHASE IIb, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE THE EFFICACY, SAFETY, AND TOLERABILITY OF SILDENAFIL ADDED TO PIRFENIDONE IN PATIENTS WITH ADVANCED IDIOPATHIC PULMONARY FIBROSIS AND RISK OF GROUP 3 PULMONARY HYPERTENSION. | Pulmonary Hypertension in patients with Idiopathic pulmonary fibrosis (IPF) MedDRA version: 20.0;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Trade Name: Esbriet Product Name: Esbriet Product Code: RO0220912 INN or Proposed INN: PIRFENIDONE Trade Name: Sildenafil Product Name: Sildenafil Product Code: RO0280296 INN or Proposed INN: SILDENAFIL | F. Hoffmann-La Roche Ltd | NULL | Not Recruiting | Female: yes Male: yes | 176 | Phase 2 | United Arab Emirates;Greece;Spain;Turkey;Israel;Italy;Egypt;Czech Republic;Hungary;Canada;Belgium;South Africa;Netherlands;Germany | ||
| 10 | EUCTR2015-005131-40-IT (EUCTR) | 09/11/2016 | 25/05/2021 | A Study to Evaluate the Efficacy, Safety, and Tolerability of Sildenafil Added to Pirfenidone in Patients with Advanced Idiopathic Pulmonary Fibrosis and Risk of Pulmonary Hypertension due to the lung disease. | A PHASE IIb, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE THE EFFICACY, SAFETY, AND TOLERABILITY OF SILDENAFIL ADDED TO PIRFENIDONE IN PATIENTS WITH ADVANCED IDIOPATHIC PULMONARY FIBROSIS AND RISK OF GROUP 3 PULMONARY HYPERTENSION. - na | Pulmonary Hypertension in patients with Idiopathic pulmonary fibrosis (IPF) MedDRA version: 21.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Trade Name: Esbriet Product Name: ESBRIET Product Code: [RO0220912] INN or Proposed INN: 00322900 Trade Name: Sildenafil Product Name: sildenafil Product Code: [G048E03] INN or Proposed INN: 00258901 | F. HOFFMANN - LA ROCHE LTD. | NULL | Not Recruiting | Female: yes Male: yes | 176 | Phase 2 | United Arab Emirates;Czechia;Greece;Spain;Turkey;Israel;Italy;Egypt;Czech Republic;Hungary;Canada;Belgium;South Africa;Germany;Netherlands | ||
| 11 | EUCTR2015-005131-40-ES (EUCTR) | 20/10/2016 | 09/09/2016 | A Study to Evaluate the Efficacy, Safety, and Tolerability of Sildenafil Added to Pirfenidone in Patients with Advanced Idiopathic Pulmonary Fibrosis and Intermediate or High Probability of Pulmonary Hypertension due to the lung disease. | A PHASE IIb, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE THE EFFICACY, SAFETY, AND TOLERABILITY OF SILDENAFIL ADDED TO PIRFENIDONE IN PATIENTS WITH ADVANCED IDIOPATHIC PULMONARY FIBROSIS AND INTERMEDIATE OR HIGH PROBABILITY OF GROUP 3 PULMONARY HYPERTENSION. | Pulmonary Hypertension in patients with Idiopathic pulmonary fibrosis (IPF) MedDRA version: 19.0;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Trade Name: Esbriet Product Name: Esbriet Product Code: RO0220912 INN or Proposed INN: PIRFENIDONE Trade Name: Sildenafil Product Name: Sildenafil Product Code: RO0280296 INN or Proposed INN: SILDENAFIL | F. Hoffmann-La Roche Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 176 | Phase 2 | United Arab Emirates;Greece;Spain;Turkey;Israel;Italy;Egypt;Czech Republic;Hungary;Canada;Belgium;South Africa;Germany;Netherlands | ||
| 12 | EUCTR2015-003280-11-NL (EUCTR) | 29/04/2016 | 19/01/2016 | A Study of the Safety and Tolerability of Pirfenidone (Esbriet) in Combination with Nintedanib (Ofev) in Patients with Idiopathic Pulmonary Fibrosis | AN EXPLORATORY MULTICENTER, OPEN-LABEL, SINGLE ARM STUDY OF THE SAFETY AND TOLERABILITY OF PIRFENIDONE (ESBRIET®) IN COMBINATION WITH NINTEDANIB (OFEV®) IN PATIENTS WITH IDIOPATHIC PULMONARY FIBROSIS | Idiopathic Pulmonary Fibrosis (IPF) MedDRA version: 19.0;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Trade Name: Esbriet Product Name: Esbriet Product Code: RO0220912 INN or Proposed INN: PIRFENIDONE Trade Name: Ofev Product Name: Ofev Product Code: 534-1508 INN or Proposed INN: NINTEDANIB Trade Name: Ofev Product Name: Ofev Product Code: 534-1508 INN or Proposed INN: NINTEDANIB | F. Hoffmann-La Roche Ltd | NULL | Not Recruiting | Female: yes Male: yes | 80 | Phase 4 | France;United States;Canada;Spain;Denmark;Germany;Netherlands;Italy | ||
| 13 | EUCTR2015-003280-11-DE (EUCTR) | 25/02/2016 | 19/10/2015 | A Study of the Safety and Tolerability of Pirfenidone (Esbriet) in Combination with Nintedanib (Ofev) in Patients with Idiopathic Pulmonary Fibrosis | AN EXPLORATORY MULTICENTER, OPEN-LABEL, SINGLE ARM STUDY OF THE SAFETY AND TOLERABILITY OF PIRFENIDONE (ESBRIET®) IN COMBINATION WITH NINTEDANIB (OFEV®) IN PATIENTS WITH IDIOPATHIC PULMONARY FIBROSIS | Idiopathic Pulmonary Fibrosis (IPF) MedDRA version: 19.0;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Trade Name: Esbriet Product Name: Esbriet Product Code: RO0220912 INN or Proposed INN: PIRFENIDONE Trade Name: Ofev Product Name: Ofev Product Code: 534-1508 INN or Proposed INN: NINTEDANIB Trade Name: Ofev Product Name: Ofev Product Code: 534-1508 INN or Proposed INN: NINTEDANIB | F. Hoffmann-La Roche Ltd | NULL | Not Recruiting | Female: yes Male: yes | 80 | Phase 4 | France;United States;Canada;Spain;Denmark;Netherlands;Germany;Italy | ||
| 14 | EUCTR2015-003280-11-DK (EUCTR) | 20/01/2016 | 25/11/2015 | A Study of the Safety and Tolerability of Pirfenidone (Esbriet) in Combination with Nintedanib (Ofev) in Patients with Idiopathic Pulmonary Fibrosis | AN EXPLORATORY MULTICENTER, OPEN-LABEL, SINGLE ARM STUDY OF THE SAFETY AND TOLERABILITY OF PIRFENIDONE (ESBRIET®) IN COMBINATION WITH NINTEDANIB (OFEV®) IN PATIENTS WITH IDIOPATHIC PULMONARY FIBROSIS | Idiopathic Pulmonary Fibrosis (IPF) MedDRA version: 19.0;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Trade Name: Esbriet Product Name: Esbriet Product Code: RO0220912 INN or Proposed INN: PIRFENIDONE Trade Name: Ofev Product Name: Ofev Product Code: 534-1508 INN or Proposed INN: NINTEDANIB Trade Name: Ofev Product Name: Ofev Product Code: 534-1508 INN or Proposed INN: NINTEDANIB | F. Hoffmann-La Roche Ltd | NULL | Not Recruiting | Female: yes Male: yes | 80 | Phase 4 | France;United States;Canada;Spain;Denmark;Netherlands;Germany;Italy | ||
| 15 | NCT02598193 (ClinicalTrials.gov) | January 14, 2016 | 4/11/2015 | Safety and Tolerability Study of Pirfenidone in Combination With Nintedanib in Participants With Idiopathic Pulmonary Fibrosis (IPF) | An Exploratory Multicenter, Open-Label, Single Arm Study of the Safety and Tolerability of Pirfenidone (Esbriet®) in Combination With Nintedanib (Ofev®) in Patients With Idiopathic Pulmonary Fibrosis | Idiopathic Pulmonary Fibrosis | Drug: Nintedanib;Drug: Pirfenidone | Hoffmann-La Roche | NULL | Completed | 40 Years | 80 Years | All | 89 | Phase 4 | United States;Canada;Denmark;France;Germany;Italy;Netherlands;Spain |
| 16 | EUCTR2015-000640-42-IT (EUCTR) | 22/12/2015 | 22/02/2018 | Safety, tolerability and PK of nintedanib in combination with pirfenidone in IPF | A twelve week, open-label, randomised, parallel-group study evaluating safety, tolerability and pharmacokinetics (PK) of oral nintedanib incombination with oral pirfenidone, compared to treatment with nintedanib alone, in patients with idiopathic pulmonary fibrosis (IPF) - - | Idiopathic Pulmonary Fibrosis MedDRA version: 20.0;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Trade Name: Ofev INN or Proposed INN: nintedanib Other descriptive name: nintedanib Trade Name: Ofev INN or Proposed INN: Nintedanib Other descriptive name: NINTEDANIB Trade Name: Esbriet INN or Proposed INN: PIRFENIDONE Other descriptive name: PIRFENIDONE | BOEHRINGER-INGELHEIM ITALIA S.P.A. | NULL | Not Recruiting | Female: yes Male: yes | 135 | Phase 4 | France;United States;Canada;Netherlands;Germany;Italy | ||
| 17 | EUCTR2015-003280-11-IT (EUCTR) | 17/12/2015 | 27/05/2021 | A Study of the Safety and Tolerability of Pirfenidone (Esbriet) in Combination with Nintedanib (Ofev) in Patients with Idiopathic Pulmonary Fibrosis | AN EXPLORATORY MULTICENTER, OPEN-LABEL, SINGLE ARM STUDY OF THE SAFETY AND TOLERABILITY OF PIRFENIDONE (ESBRIET¿) IN COMBINATION WITH NINTEDANIB (OFEV¿) IN PATIENTS WITH IDIOPATHIC PULMONARY FIBROSIS - NA | Idiopathic Pulmonary Fibrosis (IPF) MedDRA version: 21.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Trade Name: ESBRIET - 267 MG - CAPSULA RIGIDA - USO ORALE - FLACONE (HDPE) 270 CAPSULE Product Name: Esbriet Product Code: RO0220912 INN or Proposed INN: PIRFENIDONE Trade Name: Ofev INN or Proposed INN: NINTEDANIB Trade Name: Ofev INN or Proposed INN: NINTEDANIB | F. HOFFMANN - LA ROCHE LTD. | NULL | Not Recruiting | Female: yes Male: yes | 80 | Phase 4 | France;United States;Canada;Spain;Denmark;Netherlands;Germany;Italy | ||
| 18 | EUCTR2015-003280-11-ES (EUCTR) | 16/12/2015 | 30/10/2015 | A Study of the Safety and Tolerability of Pirfenidone (Esbriet) in Combination with Nintedanib (Ofev) in Patients with Idiopathic Pulmonary Fibrosis | AN EXPLORATORY MULTICENTER, OPEN-LABEL, SINGLE ARM STUDY OF THE SAFETY AND TOLERABILITY OF PIRFENIDONE (ESBRIET®) IN COMBINATION WITH NINTEDANIB (OFEV®) IN PATIENTS WITH IDIOPATHIC PULMONARY FIBROSIS | Idiopathic Pulmonary Fibrosis (IPF) MedDRA version: 18.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Trade Name: Esbriet Product Name: Esbriet Product Code: RO0220912 INN or Proposed INN: PIRFENIDONE Trade Name: Ofev Product Name: Ofev Product Code: 534-1508 INN or Proposed INN: NINTEDANIB Trade Name: Ofev Product Name: Ofev Product Code: 534-1508 INN or Proposed INN: NINTEDANIB | Roche Farma S.A., que representa en España a F. Hoffmann-La Roche Ltd | NULL | Not Recruiting | Female: yes Male: yes | 80 | Phase 4 | France;United States;Canada;Spain;Denmark;Netherlands;Germany;Italy | ||
| 19 | EUCTR2015-000640-42-DE (EUCTR) | 01/12/2015 | 03/09/2015 | Safety, tolerability and PK of nintedanib in combination with pirfenidone in IPF | A twelve week, open-label, randomised, parallel-group study evaluating safety, tolerability and pharmacokinetics (PK) of oral nintedanib in combination with oral pirfenidone, compared to treatment with nintedanib alone, in patients with idiopathic pulmonary fibrosis (IPF) - Safety, tolerability and PK of nintedanib iin combination with pirfenidone in IPF | Idiopathic Pulmonary Fibrosis MedDRA version: 19.0;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Trade Name: Ofev Product Name: Ofev 100 mg capsule Product Code: nintedanib INN or Proposed INN: nintedanib Other descriptive name: NINTEDANIB Trade Name: Ofev Product Name: Ofev 150 mg capsule Product Code: nintedanib INN or Proposed INN: nintedanib Other descriptive name: NINTEDANIB Trade Name: Esbriet Product Name: pirfenidone Product Code: pirfenidone INN or Proposed INN: PIRFENIDONE Other descriptive name: PIRFENIDONE | Boehringer Ingelheim Pharma GmbH & Co.KG | NULL | Not Recruiting | Female: yes Male: yes | 135 | Phase 4 | France;United States;Canada;Netherlands;Germany;Italy | ||
| 20 | EUCTR2014-000861-32-DE (EUCTR) | 01/12/2015 | 02/09/2015 | Standard-armed controlled study to assess the impact of oral Pirfenidone for progressive, non-IPF Lung Fibrosis (RELIEF) | Exploring Efficacy and Safety of oral Pirfenidone for progressive, non-IPF Lung Fibrosis (RELIEF)A randomized, double-blind, placebo-controlled, parallel group, multi-center, phase II trial - RELIEF | 1.Fibrotic NSIP., 2.Chronic Hypersensitivity Pneumonitis 3. Lung fibrosis associated with collagen / vascular diseases, 4.Asbestos-induced lung fibrosis MedDRA version: 20.0;Level: LLT;Classification code 10022612;Term: Interstitial lung fibrosis;System Organ Class: 100000004855 MedDRA version: 20.0;Classification code 10035754;Term: Pneumonitis hypersensitivity;Classification code 10025088;Term: Lung fibrosis;Classification code 10022617;Term: Interstitial pneumonia;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Trade Name: Esbriet® (Pirfenidon) Product Name: Esbriet® (Pirfenidon) Product Code: PZN 8881655(RochePharma AG) INN or Proposed INN: PIRFENIDONE | Justus Liebig Universität Giessen | NULL | Not Recruiting | Female: yes Male: yes | 374 | Phase 2 | Germany | ||
| 21 | EUCTR2015-000640-42-NL (EUCTR) | 13/10/2015 | 18/08/2015 | Safety, tolerability and PK of nintedanib in combination with pirfenidone in IPF | A twelve week, open-label, randomised, parallel-group study evaluating safety, tolerability and pharmacokinetics (PK) of oral nintedanib in combination with oral pirfenidone, compared to treatment with nintedanib alone, in patients with idiopathic pulmonary fibrosis (IPF) - Safety, tolerability and PK of nintedanib iin combination with pirfenidone in IPF | Idiopathic Pulmonary Fibrosis MedDRA version: 18.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Trade Name: Ofev Product Name: Ofev 100 mg capsule Product Code: nintedanib INN or Proposed INN: nintedanib Other descriptive name: NINTEDANIB Trade Name: Ofev Product Name: Ofev 150 mg capsule Product Code: nintedanib INN or Proposed INN: nintedanib Other descriptive name: NINTEDANIB Trade Name: Esbriet Product Name: pirfenidone Product Code: pirfenidone INN or Proposed INN: PIRFENIDONE Other descriptive name: PIRFENIDONE | Boehringer Ingelheim bv | NULL | Not Recruiting | Female: yes Male: yes | 135 | Phase 4 | France;United States;Canada;Germany;Netherlands;Italy | ||
| 22 | EUCTR2015-000640-42-FR (EUCTR) | 26/08/2015 | 05/08/2015 | Safety, tolerability and PK of nintedanib in combination with pirfenidone in IPF | A twelve week, open-label, randomised, parallel-group study evaluating safety, tolerability and pharmacokinetics (PK) of oral nintedanib in combination with oral pirfenidone, compared to treatment with nintedanib alone, in patients with idiopathic pulmonary fibrosis (IPF) - Safety, tolerability and PK of nintedanib in combination with pirfenidone in IPF | Idiopathic Pulmonary Fibrosis MedDRA version: 18.0;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Trade Name: Ofev Product Name: Ofev 100 mg capsule Product Code: nintedanib INN or Proposed INN: nintedanib Other descriptive name: NINTEDANIB Trade Name: Ofev Product Name: Ofev 150 mg capsule Product Code: nintedanib INN or Proposed INN: nintedanib Other descriptive name: NINTEDANIB Trade Name: Esbriet Product Name: pirfenidone Product Code: pirfenidone INN or Proposed INN: PIRFENIDONE Other descriptive name: PIRFENIDONE | Boehringer Ingelheim France | NULL | Not Recruiting | Female: yes Male: yes | 135 | Phase 4 | United States;France;Canada;Netherlands;Germany;Italy | ||
| 23 | NCT02622477 (ClinicalTrials.gov) | June 2014 | 2/12/2015 | Clinical Progression of Mild to Moderate Idiopathic Pulmonary Fibrosis (IPF) Under a Therapy With Esbriet® (Pirfenidone) | Clinical Course of Treatment With ESBRIET in Patients With Mild to Moderate IPF | Idiopathic Pulmonary Fibrosis | Drug: Pirfenidone | Hoffmann-La Roche | InterMune Deutschland GmbH | Completed | N/A | N/A | All | 12 | N/A | Germany |
| 24 | EUCTR2013-001163-24-BE (EUCTR) | 28/04/2014 | 10/02/2014 | A Study of Lebrikizumab in Patients With Idiopathic Pulmonary Fibrosis. | A PHASE II, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, STUDY TO ASSESS THE EFFICACY AND SAFETY OF LEBRIKIZUMAB IN PATIENTS WITH IDIOPATHIC PULMONARY FIBROSIS. | IDIOPATHIC PULMONARY FIBROSIS;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: lebrikizumab Product Code: RO5490255/F01-02 INN or Proposed INN: LEBRIKIZUMAB Other descriptive name: TNX-650, rhuMAb anti-IL13, aIL-13, MILR1444A Trade Name: ESBRIET INN or Proposed INN: PIRFENIDONE | F. Hoffmann-La Roche Ltd | NULL | Not Recruiting | Female: yes Male: yes | 480 | Phase 2 | United States;Spain;United Kingdom;Italy;France;Mexico;Canada;Belgium;Poland;Australia;Peru;Germany;Japan | ||
| 25 | EUCTR2013-001163-24-PL (EUCTR) | 09/11/2013 | 01/10/2013 | A Study of Lebrikizumab in Patients With Idiopathic Pulmonary Fibrosis. | A PHASE II, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, STUDY TO ASSESS THE EFFICACY AND SAFETY OF LEBRIKIZUMAB IN PATIENTS WITH IDIOPATHIC PULMONARY FIBROSIS. | IDIOPATHIC PULMONARY FIBROSIS;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: lebrikizumab Product Code: RO5490255/F01-02 INN or Proposed INN: LEBRIKIZUMAB Other descriptive name: TNX-650, rhuMAb anti-IL13, aIL-13, MILR1444A Trade Name: ESBRIET INN or Proposed INN: PIRFENIDONE | F. Hoffmann-La Roche Ltd | NULL | Not Recruiting | Female: yes Male: yes | 480 | Phase 2 | United States;Spain;United Kingdom;Italy;France;Mexico;Canada;Poland;Belgium;Australia;Peru;Germany;Japan | ||
| 26 | EUCTR2013-001163-24-DE (EUCTR) | 04/11/2013 | 28/08/2013 | A Study of Lebrikizumab in Patients With Idiopathic Pulmonary Fibrosis. | A PHASE II, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, STUDY TO ASSESS THE EFFICACY AND SAFETY OF LEBRIKIZUMAB IN PATIENTS WITH IDIOPATHIC PULMONARY FIBROSIS. | IDIOPATHIC PULMONARY FIBROSIS;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: lebrikizumab Product Code: RO5490255/F01-02 INN or Proposed INN: LEBRIKIZUMAB Other descriptive name: TNX-650, rhuMAb anti-IL13, aIL-13, MILR1444A Trade Name: ESBRIET INN or Proposed INN: PIRFENIDONE | F. Hoffmann-La Roche Ltd | NULL | Not Recruiting | Female: yes Male: yes | 480 | Phase 2 | United States;Spain;United Kingdom;Italy;France;Mexico;Canada;Belgium;Poland;Australia;Peru;Germany;Japan | ||
| 27 | EUCTR2013-001163-24-GB (EUCTR) | 14/10/2013 | 06/11/2013 | A Study of Lebrikizumab in Patients With Idiopathic Pulmonary Fibrosis. | A PHASE II, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, STUDY TO ASSESS THE EFFICACY AND SAFETY OF LEBRIKIZUMAB IN PATIENTS WITH IDIOPATHIC PULMONARY FIBROSIS. | IDIOPATHIC PULMONARY FIBROSIS;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: lebrikizumab Product Code: RO5490255/F01-02 INN or Proposed INN: LEBRIKIZUMAB Other descriptive name: TNX-650, rhuMAb anti-IL13, aIL-13, MILR1444A Trade Name: ESBRIET INN or Proposed INN: PIRFENIDONE | F. Hoffmann-La Roche Ltd | NULL | Not Recruiting | Female: yes Male: yes | 480 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | United States;Spain;United Kingdom;Italy;France;Mexico;Canada;Belgium;Poland;Australia;Peru;Germany;Japan | ||
| 28 | NCT02699879 (ClinicalTrials.gov) | February 16, 2012 | 26/2/2016 | Evaluation of Long-Term Safety of Pirfenidone (Esbriet) in Participants With Idiopathic Pulmonary Fibrosis (IPF) | Post-Authorisation Safety Study of Esbriet® (Pirfenidone): A Prospective Observational Registry to Evaluate Long-Term Safety in a Real-World Setting | Idiopathic Pulmonary Fibrosis | Drug: Pirfenidone | Hoffmann-La Roche | NULL | Completed | N/A | N/A | All | 1009 | N/A | Austria;Denmark;Finland;France;Germany;Ireland;Italy;Norway;Sweden;United Kingdom |