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Clinical trials for 2015-005385-38

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

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    1 result(s) found for: 2015-005385-38. Displaying page 1 of 1.
    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)
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    The status and protocol content of GB trials is no longer updated since 1 January 2021.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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