Flag of the European Union EU Clinical Trials Register Help

Clinical trials for Pirfenidone

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   44334   clinical trials with a EudraCT protocol, of which   7366   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     
    43 result(s) found for: Pirfenidone. Displaying page 1 of 3.
    1  2  3  Next»
    EudraCT Number: 2018-001781-41 Sponsor Protocol Number: NVALT1asbestosis Start Date*: 2019-03-07
    Sponsor Name:Nederlandse Vereniging van Artsen voor longziekten en Tuberculose
    Full Title: Evaluation of safety and tolerability of pirfenidone in asbestosis, a multicenter study
    Medical condition: asbestosis
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: NL (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2015-003280-11 Sponsor Protocol Number: MA29895 Start Date*: 2016-02-25
    Sponsor Name:F. Hoffmann-La Roche Ltd
    Full Title: 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
    Medical condition: Idiopathic Pulmonary Fibrosis (IPF)
    Disease: Version SOC Term Classification Code Term Level
    19.0 10038738 - Respiratory, thoracic and mediastinal disorders 10021240 Idiopathic pulmonary fibrosis PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) ES (Completed) DK (Completed) NL (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2015-000640-42 Sponsor Protocol Number: 1199.222 Start Date*: 2015-08-26
    Sponsor Name:Boehringer Ingelheim France
    Full Title: 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 ...
    Medical condition: Idiopathic Pulmonary Fibrosis
    Disease: Version SOC Term Classification Code Term Level
    18.0 10038738 - Respiratory, thoracic and mediastinal disorders 10021240 Idiopathic pulmonary fibrosis PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Completed) NL (Completed) DE (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2007-007800-13 Sponsor Protocol Number: PIPF-012 Start Date*: 2008-06-04
    Sponsor Name:InterMune, Inc.
    Full Title: An Open-Label Extension Study of the Long-Term Safety of Pirfenidone in Patients with Idiopathic Pulmonary Fibrosis (IPF) Who Complete the CAPACITY Studies
    Medical condition: Idiopathic Pulmonary Fibrosis (IPF)
    Disease: Version SOC Term Classification Code Term Level
    9.1 10021240 Idiopathic pulmonary fibrosis LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: IE (Completed) GB (Completed) DE (Completed) FR (Completed) BE (Completed) ES (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2016-003827-45 Sponsor Protocol Number: MA39293-DIET Start Date*: 2017-12-21
    Sponsor Name:CIBER - Instituto Carlos III [...]
    1. CIBER - Instituto Carlos III
    2. Institut d'Investigació Biomédica de Bellvitge (IDIBELL)
    Full Title: 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
    Medical condition: Idiopathic Pulmonary Fibrosis
    Disease: Version SOC Term Classification Code Term Level
    20.0 10038738 - Respiratory, thoracic and mediastinal disorders 10021240 Idiopathic pulmonary fibrosis PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Ongoing) GB (GB - no longer in EU/EEA) GR (Completed)
    Trial results: (No results available)
    EudraCT Number: 2020-002518-42 Sponsor Protocol Number: FIBRO-COVID Start Date*: 2020-07-20
    Sponsor Name:IDIBELL
    Full Title: A RANDOMIZED PHASE-II CLINICAL TRIAL TO EVALUATE THE EFFECT OF PIRFENIDONE COMPARED WITH PLACEBO IN PULMONARY FIBROSIS POST-COVID 19:
    Medical condition: Pulmonary fibrosis induced by SARS-COV2 virus (post-COVID19 pulmonary sequelae)
    Disease: Version SOC Term Classification Code Term Level
    21.0 10038738 - Respiratory, thoracic and mediastinal disorders 10037383 Pulmonary fibrosis PT
    23.0 100000004862 10084510 Coronavirus infections HLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: ES (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2014-002022-12 Sponsor Protocol Number: EPOS-CT-001 Start Date*: 2015-08-06
    Sponsor Name:Clinical Trials Unit, Rigshospitalet
    Full Title: A European multi-centre, randomised, double-blind trial of pirfenidone in bronchiolitis-obliterans-syndrome grade 1-3 in lung transplant recipients.
    Medical condition: Bronchiolitis Obliterans Syndrome (BOS) in patients following lung transplantation. This syndrome occurs due to rejection of the transplanted organ (s).
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004855 10049202 Bronchiolitis obliterans LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: SE (Completed) GB (GB - no longer in EU/EEA) BE (Completed) DE (Completed) NL (Completed) DK (Completed)
    Trial results: (No results available)
    EudraCT Number: 2021-002701-94 Sponsor Protocol Number: FUN-PIR-2020-01 Start Date*: 2021-08-13
    Sponsor Name:Fundación para la Gestión de la Investigación Biomédica de Cádiz
    Full Title: Pirfenidone for the reduction of pulmonary inflammatory and fibrogenic activity in patients with silicosis due to artificial stone and progressive massive fibrosis.
    Medical condition: progressive massive fibrosis
    Disease: Version SOC Term Classification Code Term Level
    20.0 10022117 - Injury, poisoning and procedural complications 10040678 Silicosis PT
    21.1 10038738 - Respiratory, thoracic and mediastinal disorders 10036805 Progressive massive fibrosis PT
    Population Age: Adults Gender: Male, Female
    Trial protocol: ES (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2019-004326-19 Sponsor Protocol Number: 69HCL19_0029 Start Date*: 2020-01-27
    Sponsor Name:Hospices Civils de Lyon
    Full Title: Pragmatic management of progressive disease in idiopathic pulmonary fibrosis: a randomized trial
    Medical condition: Idiopathic pulmonary fibrosis
    Disease: Version SOC Term Classification Code Term Level
    21.1 10038738 - Respiratory, thoracic and mediastinal disorders 10021240 Idiopathic pulmonary fibrosis PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2016-002744-17 Sponsor Protocol Number: MA39189 Start Date*: 2017-03-29
    Sponsor Name:Roche Farma S.A, que representa en España a F. Hoffmann-La Roche Ltd
    Full Title: MULTICENTER, INTERNATIONAL, DOUBLEBLIND, TWO-ARM, RANDOMIZED, PLACEBO CONTROLLED PHASE II TRIAL OF PIRFENIDONE IN PATIENTS WITH UNCLASSIFIABLE PROGRESSIVE FIBROSING ILD
    Medical condition: Fibrosing interstitial lung disease (ILD) of unknown origin
    Disease: Version SOC Term Classification Code Term Level
    19.1 10038738 - Respiratory, thoracic and mediastinal disorders 10022611 Interstitial lung disease PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Completed) DK (Completed) CZ (Completed) DE (Completed) PL (Completed) PT (Completed) GR (Completed) BE (Completed) GB (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2020-005103-39 Sponsor Protocol Number: AP01-005 Start Date*: 2021-04-16
    Sponsor Name:Avalyn Pharma, Inc.
    Full Title: Access to Pirfenidone Solution for Inhalation (AP01) for Treatment of Progressive, Fibrosing Interstitial Lung Diseases, including Idiopathic Pulmonary Fibrosis
    Medical condition: Interstitial Lung Diseases (ILD), including but not limited to idiopathic pulmonary fibrosis (IPF)
    Disease: Version SOC Term Classification Code Term Level
    21.1 10038738 - Respiratory, thoracic and mediastinal disorders 10022611 Interstitial lung disease PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: CZ (Trial now transitioned) NL (Trial now transitioned) PL (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2013-001163-24 Sponsor Protocol Number: GB28547 Start Date*: 2013-11-04
    Sponsor Name:F. Hoffmann-La Roche Ltd
    Full Title: A PHASE II, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, STUDY TO ASSESS THE EFFICACY AND SAFETY OF LEBRIKIZUMAB IN PATIENTS WITH IDIOPATHIC PULMONARY FIBROSIS.
    Medical condition: IDIOPATHIC PULMONARY FIBROSIS
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) IT (Completed) ES (Completed) PL (Completed) GB (Completed) BE (Completed) FR (Completed)
    Trial results: View results
    EudraCT Number: 2015-005131-40 Sponsor Protocol Number: MA29957 Start Date*: 2016-10-20
    Sponsor Name:F. Hoffmann-La Roche Ltd
    Full Title: 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 IDIOPATH...
    Medical condition: "Pulmonary Hypertension in patients with Idiopathic pulmonary fibrosis (IPF)
    Disease: Version SOC Term Classification Code Term Level
    19.0 10038738 - Respiratory, thoracic and mediastinal disorders 10021240 Idiopathic pulmonary fibrosis PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Ongoing) NL (Completed) BE (Completed) DE (Completed) GR (Completed) HU (Completed) CZ (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2006-000138-11 Sponsor Protocol Number: PIPF-006 Start Date*: 2006-05-23
    Sponsor Name:InterMune, Inc.
    Full Title: A Randomised, Double-Blind, Placebo-Controlled, Phase 3 Study of the Safety and Efficacy of Pirfenidone in Patients with Idiophatic Pulmonary Fibrosis
    Medical condition: Idiophatic Pulmonary Fibrosis (IPF)
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: IE (Completed) DE (Completed) BE (Completed) CZ (Prematurely Ended) ES (Completed)
    Trial results: View results
    EudraCT Number: 2006-000252-41 Sponsor Protocol Number: PIPF-004 Start Date*: 2006-06-29
    Sponsor Name:InterMune, Inc.
    Full Title: A Randomized, Double-Blind, Placebo Controlled, Phase 3 Three-Arm Study of the Safety and Efficacy of Pirfenidone in Patients with Idiopathic Pulmonary Fibrosis
    Medical condition: Idiopathic Pulmonary Fibrosis (IPF)
    Disease: Version SOC Term Classification Code Term Level
    9.1 10021240 Idiopathic pulmonary fibrosis LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2014-004782-24 Sponsor Protocol Number: PRM-151-202 Start Date*: 2016-03-01
    Sponsor Name:Promedior, Inc.
    Full Title: A Phase 2 Trial to Evaluate the Efficacy of PRM-151 in Subjects with Idiopathic Pulmonary Fibrosis (IPF)
    Medical condition: Idiopathic Pulmonary Fibrosis (IPF)
    Disease: Version SOC Term Classification Code Term Level
    18.1 10038738 - Respiratory, thoracic and mediastinal disorders 10021240 Idiopathic pulmonary fibrosis PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) BE (Completed) CZ (Completed) ES (Completed) HU (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2013-001353-28 Sponsor Protocol Number: PSSc-001 Start Date*: 2013-10-04
    Sponsor Name:InterMune Inc.
    Full Title: An Open-Label, Randomized, Phase 2 Study of the Safety and Tolerability of Pirfenidone when Administered to Patients with Systemic Sclerosis-Related Interstitial Lung Disease
    Medical condition: Systemic Sclerosis-Related Interstitial Lung Disease
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: IT (Completed)
    Trial results: View results
    EudraCT Number: 2017-000149-30 Sponsor Protocol Number: Edge92882 Start Date*: 2017-10-25
    Sponsor Name:University Hospitals of Leicester NHS Trust
    Full Title: A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study of Safety, Tolerability and Efficacy of Pirfenidone in Patients with Rheumatoid Arthritis Interstitial Lung Disease
    Medical condition: Rheumatoid arthritis associated interstitial lung disease (RA-ILD)
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA)
    Trial results: (No results available)
    EudraCT Number: 2020-005306-25 Sponsor Protocol Number: Pioneer Start Date*: 2021-09-15
    Sponsor Name:OSPEDALE SAN RAFFAELE
    Full Title: PIrfenidone to prevent fibrOsis in ARDS. A RaNdomizEd controllEd tRial (PIONEER) GR-2019-12371063
    Medical condition: Acute respiratory distress syndrome (ARDS)
    Disease: Version SOC Term Classification Code Term Level
    21.1 100000004855 10003083 ARDS LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: IT (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2012-000564-14 Sponsor Protocol Number: PIPF-023 Start Date*: 2013-06-18
    Sponsor Name:InterMune International AG.
    Full Title: 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 Pirfenid...
    Medical condition: Patients with Idiopathic Pulmonary Fibrosis (IPF)
    Disease: Version SOC Term Classification Code Term Level
    17.0 10038738 - Respiratory, thoracic and mediastinal disorders 10021240 Idiopathic pulmonary fibrosis PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: BE (Completed) SE (Completed) DE (Completed) IT (Completed) AT (Completed) GB (Completed) DK (Completed)
    Trial results: View results
    Download Options:
    Number of Trials to download:
    Download Content:
    Download Format:
    Note, where multi-state trials are shown in search results, selecting "Full Trial details" will download full information for each of the member states/countries involved in the trial.
    1  2  3  Next»
    Query did not match any studies.
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

    European Medicines Agency © 1995-Thu May 01 06:28:21 CEST 2025 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA