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A Phase 2, Randomized, Placebo-controlled, Parallel Group, Multicenter 12-week Study With a 52-week Extension to Evaluate the Efficacy and Safety of Two Doses of K-808 (Pemafibrate) in Subjects With Primary Biliary Cholangitis With Inadequate Response to Ursodeoxycholic Acid and/or Obeticholic Acid Treatment

Trial Profile

A Phase 2, Randomized, Placebo-controlled, Parallel Group, Multicenter 12-week Study With a 52-week Extension to Evaluate the Efficacy and Safety of Two Doses of K-808 (Pemafibrate) in Subjects With Primary Biliary Cholangitis With Inadequate Response to Ursodeoxycholic Acid and/or Obeticholic Acid Treatment

Status: Active, no longer recruiting
Phase of Trial: Phase II

Latest Information Update: 30 May 2025

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At a glance

  • Drugs Pemafibrate (Primary)
  • Indications Cholangitis
  • Focus Therapeutic Use
  • Sponsors Kowa Pharmaceutical

Most Recent Events

  • 23 May 2025 Status changed from recruiting to active, no longer recruiting.
  • 26 Feb 2025 Planned End Date changed from 8 Apr 2026 to 1 Aug 2026.
  • 26 Feb 2025 Planned primary completion date changed from 9 Apr 2025 to 1 Aug 2025.

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