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A Phase 4, Double-Blind, Randomized, Placebo-Controlled, Multicenter Study Evaluating the Effect of Obeticholic Acid on Clinical Outcomes in Patients With Primary Biliary Cholangitis

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Trial Profile

A Phase 4, Double-Blind, Randomized, Placebo-Controlled, Multicenter Study Evaluating the Effect of Obeticholic Acid on Clinical Outcomes in Patients With Primary Biliary Cholangitis

Status: Discontinued
Phase of Trial: Phase III/IV

Latest Information Update: 15 Nov 2024

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At a glance

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

Most Recent Events

  • 12 Nov 2024 According to an Intercept Pharmaceuticals media release, the USFDA has issued a Complete Response Letter (CRL) that addresses the supplemental New Drug Application (sNDA) for OCALIVA; The FDA informed Intercept that it is unable to approve the sNDA in its current form, consistent with the outcome of the Gastrointestinal Drugs Advisory Committee (GIDAC) meeting in September 2024. In its letter, the FDA also said it was continuing to consider safety data from Study 747-302, along with other safety
  • 06 Sep 2024 Primary endpoint (Time to the First Occurrence of Primary Clinical Event (Expanded Endpoint)) has been met. acceding to According to an Intercept Pharmaceuticals media release.
  • 06 Sep 2024 According to an Intercept Pharmaceuticals media release, the company announced the first peer-reviewed publication of "COBALT: A Confirmatory Trial of Obeticholic Acid in Primary Biliary Cholangitis With Placebo and External Controls" in The American Journal of Gastroenterology.

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