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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

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: Recruiting
Phase of Trial: Phase IV

Latest Information Update: 23 Oct 2019

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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

    • 31 Aug 2018 Biomarkers information updated
    • 19 Jun 2017 Phase of the trial has been changed from Phase III to Phase IV, Planned number of patients changed from 350 to 428, time frame for primary endpoint changed from 8 years to 10 years.
    • 19 Jun 2017 Planned End Date changed from 1 Apr 2023 to 1 Apr 2025.
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