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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: 15 Nov 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

  • 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
  • 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

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