A Phase 3, Double-Blind, Randomized, Long-Term, Placebo-Controlled, Multicenter Study Evaluating the Safety and Efficacy of Obeticholic Acid in Subjects With Nonalcoholic Steatohepatitis

Trial Profile

A Phase 3, Double-Blind, Randomized, Long-Term, Placebo-Controlled, Multicenter Study Evaluating the Safety and Efficacy of Obeticholic Acid in Subjects With Nonalcoholic Steatohepatitis

Recruiting
Phase of Trial: Phase III

Latest Information Update: 10 Oct 2017

At a glance

  • Drugs Obeticholic acid (Primary)
  • Indications Hepatic fibrosis; Non-alcoholic steatohepatitis
  • Focus Registrational; Therapeutic Use
  • Acronyms REGENERATE
  • Sponsors Intercept Pharmaceuticals
  • Most Recent Events

    • 04 May 2017 According to an Intercept Pharmaceuticals media release, enrollment of interim analysis cohort has been completed.
    • 23 Feb 2017 According to an Intercept Pharmaceuticals media release, the company expects to complete the enrollment of the interim analysis cohort in this trial by mid-2017.
    • 19 Oct 2016 Trial design presented at the 81st Annual Scientific Meeting of the American College of Gastroenterology
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