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A Multicenter, Randomized, Double-blind, Placebo Controlled, Phase 2b/3 Study to Evaluate the Efficacy and Safety of Saroglitazar Magnesium in Subjects With Primary Biliary Cholangitis

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Trial Profile

A Multicenter, Randomized, Double-blind, Placebo Controlled, Phase 2b/3 Study to Evaluate the Efficacy and Safety of Saroglitazar Magnesium in Subjects With Primary Biliary Cholangitis

Status: Completed
Phase of Trial: Phase II/III

Latest Information Update: 18 Jun 2025

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At a glance

  • Drugs Saroglitazar (Primary)
  • Indications Primary biliary cirrhosis
  • Focus Registrational; Therapeutic Use
  • Acronyms EPICS-III
  • Sponsors Zydus Pharmaceuticals (USA)

Most Recent Events

  • 29 May 2025 Status changed from active, no longer recruiting to completed.
  • 08 May 2024 Planned number of patients changed from 192 to 186.
  • 08 May 2024 Planned End Date changed from 1 Oct 2024 to 14 May 2025.

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