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

Trial Profile

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

Active, no longer recruiting
Phase of Trial: Phase III

Latest Information Update: 17 Nov 2015

At a glance

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

    • 14 Nov 2015 Results will be presented at the American Academy for the Study of Liver Diseases (AASLD) Annual Meeting, according to an Intercept Pharmaceuticals media release.
    • 31 Aug 2015 According to an Intercept Pharmaceuticals media release, the FDA has accepted for review the company's New Drug Application (NDA) and granted Priority Review for obeticholic acid (OCA) for the treatment of primary biliary cirrhosis (PBC).
    • 29 Jun 2015 According to Intercept Pharmaceuticals media release, the EMA has accepted the Marketing Authorization Application (MAA) for obeticholic acid for treatment of primary biliary cirrhosis in combination with ursodeoxycholic acid (UDCA) in adults with an inadequate response to UDCA or as monotherapy in adults unable to tolerate UDCA.
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