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: 13 Dec 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

    • 22 Nov 2017 According to a Genfit media release, more than 800 oatients have been randomized.
    • 22 Nov 2017 According to a Genfit media release, Data Safety Monitoring Board (DSMB) has done 18-month Pre-Planned Safety Review, and issued a new positive recommendation for the continuation of this trial without any modifications.
    • 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.
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