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A Phase 3, Open-Label, Long-Term Safety Extension Study Evaluating the Safety and Tolerability of the Fixed-Dose Combination of Obeticholic Acid and Bezafibrate in Subjects With Primary Biliary Cholangitis

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Trial Profile

A Phase 3, Open-Label, Long-Term Safety Extension Study Evaluating the Safety and Tolerability of the Fixed-Dose Combination of Obeticholic Acid and Bezafibrate in Subjects With Primary Biliary Cholangitis

Status: Recruiting
Phase of Trial: Phase III

Latest Information Update: 28 Jan 2025

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At a glance

  • Drugs Bezafibrate/obeticholic acid (Primary)
  • Indications Primary biliary cirrhosis
  • Focus Adverse reactions; Registrational
  • Sponsors Intercept Pharmaceuticals

Most Recent Events

  • 02 Oct 2024 Planned primary completion date changed from 1 Jan 2025 to 1 Jan 2029.
  • 02 Oct 2024 Status changed from not yet recruiting to recruiting.
  • 16 Jul 2024 New trial record

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