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Clinical trials for elafibranor

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   44344   clinical trials with a EudraCT protocol, of which   7373   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 ).  
     
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    7 result(s) found for: elafibranor. Displaying page 1 of 1.
    EudraCT Number: 2019-000645-12 Sponsor Protocol Number: GFT505-219-8 Start Date*: 2019-09-03
    Sponsor Name:GENFIT SA
    Full Title: A Double-Blind, Placebo-Controlled, Cross-over Phase II Study to Evaluate the Effect of a 6-week Elafibranor (120mg) treatment administered once daily on hepatic lipid composition in subjects with ...
    Medical condition: Subjects with Nonalcoholic Fatty Liver (NAFL)
    Disease: Version SOC Term Classification Code Term Level
    22.0 100000004871 10029530 Non-alcoholic fatty liver LLT
    Population Age: Elderly Gender: Male, Female
    Trial protocol: NL (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2022-001883-91 Sponsor Protocol Number: CLIN-60190-452 Start Date*: 2022-10-07
    Sponsor Name:Ipsen Bioscience Inc
    Full Title: A Phase I, Open Label, Randomised, Balanced, Single-dose, Two-period, Two-sequence Crossover-design Study to Evaluate Effects of Food on the Bioavailability of 80 mg Elafibranor (IPN60190) To-be-ma...
    Medical condition: This is a study to evaluate the effects of food on the bioavailability of elafibranor in healthy adult participants. It is part of a clinical development program for the IMP, the intended indicatio...
    Disease: Version SOC Term Classification Code Term Level
    21.0 100000004871 10036680 Primary biliary cirrhosis LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: FR (Completed)
    Trial results: View results
    EudraCT Number: 2016-003817-80 Sponsor Protocol Number: GFT505B-216-1 Start Date*: 2017-05-22
    Sponsor Name:Genfit SA
    Full Title: A Multicenter, Double-Blind, Randomized, Placebo-Controlled, Phase 2 Study to Evaluate the Efficacy and Safety of Elafibranor at Doses of 80 mg and 120mg after 12 Weeks of Treatment in Patients Wit...
    Medical condition: Primary biliary cholangitis
    Disease: Version SOC Term Classification Code Term Level
    19.1 100000004871 10034176 PBC LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Completed) GB (Completed) FR (Completed)
    Trial results: View results
    EudraCT Number: 2019-003400-12 Sponsor Protocol Number: GFT505E-218-1 Start Date*: 2019-10-17
    Sponsor Name:GENFIT
    Full Title: An Open Label, Randomized, Multicenter Study to Assess the Pharmacokinetic and Pharmacodynamic Profile and the Safety and Tolerability of Two Dose Levels of Elafibranor (80 mg and 120 mg) in Childr...
    Medical condition: Non-Alcoholic Steato-Hepatitis (NASH)
    Disease: Version SOC Term Classification Code Term Level
    22.0 10019805 - Hepatobiliary disorders 10053219 Non-alcoholic steatohepatitis PT
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2022-002695-37 Sponsor Protocol Number: CLIN-60190-453 Start Date*: 2023-04-27
    Sponsor Name:Ipsen Bioscience, Inc.
    Full Title: A Phase II, Multicenter, Double-Blind, Randomised, Placebo-Controlled Study and Open-Label Long Term Extension to Evaluate the Safety and Efficacy of Elafibranor in Adult Participants with Primary ...
    Medical condition: Adults patients with Primary Sclerosing Cholangitis (PSC)
    Disease: Version SOC Term Classification Code Term Level
    20.1 10019805 - Hepatobiliary disorders 10036732 Primary sclerosing cholangitis LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Trial now transitioned) ES (Ongoing) PT (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2015-005385-38 Sponsor Protocol Number: GFT505-315-1 Start Date*: 2016-03-04
    Sponsor Name:Genfit SA
    Full Title: A Multicentre, Randomized, Double-Blind, Placebo-Controlled Phase III Study to Evaluate the Efficacy and Safety of Elafibranor in Patients with Non-Alcoholic Steatohepatitis (NASH) and fibrosis.
    Medical condition: Non-Alcoholic Steatohepatitis (NASH) and fibrosis
    Disease: Version SOC Term Classification Code Term Level
    20.0 10018065 - General disorders and administration site conditions 10016642 Fibrosis PT
    22.0 10019805 - Hepatobiliary disorders 10053219 Non-alcoholic steatohepatitis PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: BE (Prematurely Ended) GB (Completed) DE (Completed) CZ (Prematurely Ended) SE (Completed) IT (Prematurely Ended) PT (Completed) NL (Completed) DK (Prematurely Ended) FI (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2019-004941-34 Sponsor Protocol Number: GFT505B-319-1 Start Date*: 2020-10-09
    Sponsor Name:IPSEN Pharma SAS
    Full Title: A Double-blind Randomized, Placebo-Controlled Study and Open-label Long Term Extension to Evaluate the Efficacy and Safety of Elafibranor 80 mg in Patients with Primary Biliary Cholangitis with Ina...
    Medical condition: Primary Biliary Cholangitis
    Disease: Version SOC Term Classification Code Term Level
    21.0 10019805 - Hepatobiliary disorders 10034176 PBC LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: BE (Trial now transitioned) DE (Trial now transitioned) FR (Trial now transitioned) IT (Trial now transitioned)
    Trial results: (No results available)
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    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.

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