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A Phase 4, Double-Blind, Randomized, Placebo-Controlled Study Evaluating the Pharmacokinetics and Safety of Obeticholic Acid in Patients With Primary Biliary Cholangitis and Moderate to Severe Hepatic Impairment

Trial Profile

A Phase 4, Double-Blind, Randomized, Placebo-Controlled Study Evaluating the Pharmacokinetics and Safety of Obeticholic Acid in Patients With Primary Biliary Cholangitis and Moderate to Severe Hepatic Impairment

Status: Discontinued
Phase of Trial: Phase IV

Latest Information Update: 06 Mar 2024

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At a glance

  • Drugs Obeticholic acid (Primary)
  • Indications Primary biliary cirrhosis
  • Focus Adverse reactions; Pharmacokinetics; Registrational
  • Sponsors Intercept Pharmaceuticals
  • Most Recent Events

    • 29 Feb 2024 ording to an Intercept Pharmaceuticals media release, the company announced that the U.S. Food and Drug Administration (FDA) has accepted its supplemental New Drug Application (sNDA) for Ocaliva for the treatment of PBC. The sNDA is supported by data from the Company's post-marketing requirement studies COBALT and Study 401 as well as real-world evidence from a U.S. claims database and international PBC patient registries. The FDA has assigned a Prescription Drug User Fee Act (PDUFA) target acti
    • 15 Oct 2022 This trial has been discontinued in Poland, according to European Clinical Trials Database record
    • 30 Jul 2021 Status changed from active, no longer recruiting to discontinued. Reason the study was stopped: Due to Ocaliva (obeticholic acid) US labeling update, the sponsor decided to terminate the study.
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