A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase III Study to Evaluate the Efficacy and Safety of Elafibranor in Patients With Nonalcoholic Steatohepatitis (NASH) and Fibrosis

Trial Profile

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase III Study to Evaluate the Efficacy and Safety of Elafibranor in Patients With Nonalcoholic Steatohepatitis (NASH) and Fibrosis

Recruiting
Phase of Trial: Phase III

Latest Information Update: 18 Oct 2017

At a glance

  • Drugs Elafibranor (Primary)
  • Indications Fibrosis; Non-alcoholic steatohepatitis
  • Focus Adverse reactions; Registrational; Therapeutic Use
  • Acronyms RESOLVE-IT
  • Sponsors Genfit
  • Most Recent Events

    • 01 Jun 2017 According to a Genfit media release, the Data Safety Monitoring Board (DSMB) has reviewed safety data during 1-year pre-planned analysis and has recommended continuation of this trial without any modifications.
    • 24 Apr 2017 According to a Genfit media release, enrolment of the first ~1000 patients to participate in the first phase of the trial is expected to be completed in Q1 2018.
    • 08 Feb 2017 According to a GENFIT media release, subject to satisfactory clinical results obtained during the first stage of this study in a first group of approximately 1,000 patients, which company anticipates can be recruited by the Summer of 2017 and could lead to Subpart H conditional marketing authorization during the second half of 2019 or the first half of 2020.
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