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Clinical trial

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.

NCT06383403 is registered in ClinicalTrials.gov with Ipsen as lead sponsor.

NCT NCT06383403
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Registry record

As filed in ClinicalTrials.gov.

Title
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.
Lead sponsor
Ipsen
Phase
Phase 3
Overall status
Completed
Start date
July 9, 2024
Completion date
June 16, 2026
Enrollment
92 (actual)
Sites
60

Conditions

As the registry lists them; a condition with its own page is linked.

primary biliary cholangitis