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A Phase IIIb Randomised, Parallel-Group, Double-Blind, Placebo-Controlled, Two-Arm Study to Evaluate the Effect of Elafibranor 80 mg on Normalisation of Alkaline Phosphatase in Adult Participants With Primary Biliary Cholangitis (PBC) and Inadequate Response or Intolerance to Ursodeoxycholic Acid

Trial Profile

A Phase IIIb Randomised, Parallel-Group, Double-Blind, Placebo-Controlled, Two-Arm Study to Evaluate the Effect of Elafibranor 80 mg on Normalisation of Alkaline Phosphatase in Adult Participants With Primary Biliary Cholangitis (PBC) and Inadequate Response or Intolerance to Ursodeoxycholic Acid

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

Latest Information Update: 09 May 2025

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At a glance

  • Drugs Elafibranor (Primary)
  • Indications Primary biliary cirrhosis
  • Focus Registrational; Therapeutic Use
  • Acronyms ELSPIRE
  • Sponsors Ipsen

Most Recent Events

  • 01 May 2025 Status changed from recruiting to active, no longer recruiting.
  • 02 Aug 2024 Planned End Date changed from 21 Dec 2026 to 31 Oct 2026.
  • 02 Aug 2024 Planned primary completion date changed from 22 Jun 2026 to 31 Oct 2026.

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