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A Phase 3, Double Blind, Placebo Controlled Trial and Long Term Safety Extension of Obeticholic Acid in Patients With Primary Biliary Cirrhosis

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Trial Profile

A Phase 3, Double Blind, Placebo Controlled Trial and Long Term Safety Extension of Obeticholic Acid in Patients With Primary Biliary Cirrhosis

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 08 May 2025

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At a glance

  • Drugs Obeticholic acid (Primary)
  • Indications Primary biliary cirrhosis
  • Focus Registrational; Therapeutic Use
  • Acronyms POISE
  • Sponsors Intercept Pharmaceuticals

Most Recent Events

  • 30 Apr 2025 According to an Intercept Pharmaceuticals media release, the company announced data from this trial is selected as Poster Presentations that will be presented at Digestive Disease Week 2025 on Monday, May 5, 12:30 PM ET The conference will be held from May 3-6 in San Diego.
  • 04 Jun 2024 According to an Intercept Pharmaceuticals media release, the company announced new sub-analyses from this trial in primary biliary cholangitis (PBC) showing the effect of obeticholic acid (OCA) across a number of key biomarkers of liver health in people living with PBC will be presented at the European Association for the Study of the Liver (EASL) Congress 2024 being held June 5-8, 2024, in Milan, Italy.
  • 04 Jun 2024 Results presented in an Intercept Pharmaceuticals Media Release.

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