A Phase 4, Double Blind, Randomized, Placebo Controlled, Multicenter Study Evaluating the Effect of Obeticholic Acid on Clinical Outcomes in Subjects with Primary Biliary Cholangitis. The COBALT Study Clinical Outcomes with OBetichilic Acid in Liver Treatment (COBALT)

Trial Profile

A Phase 4, Double Blind, Randomized, Placebo Controlled, Multicenter Study Evaluating the Effect of Obeticholic Acid on Clinical Outcomes in Subjects with Primary Biliary Cholangitis. The COBALT Study Clinical Outcomes with OBetichilic Acid in Liver Treatment (COBALT)

Recruiting
Phase of Trial: Phase IV

Latest Information Update: 02 Nov 2017

At a glance

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

    • 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.
    • 19 Jun 2017 Planned primary completion date changed from 1 Dec 2022 to 1 Dec 2024.
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