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Clinical trial

A Double-blind, Randomized, Placebo-Controlled Study and Open-label Long Term Extension to Evaluate the Efficacy and Safety of Elafibranor 80 mg in Patients With Primary Biliary Cholangitis With Inadequate Response or Intolerance to Ursodeoxycholic Acid

NCT04526665 is registered in ClinicalTrials.gov with Ipsen as lead sponsor.

NCT NCT04526665
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Registry record

As filed in ClinicalTrials.gov.

Title
A Double-blind, Randomized, Placebo-Controlled Study and Open-label Long Term Extension to Evaluate the Efficacy and Safety of Elafibranor 80 mg in Patients With Primary Biliary Cholangitis With Inadequate Response or Intolerance to Ursodeoxycholic Acid
Lead sponsor
Ipsen
Phase
Phase 3
Overall status
Active, not recruiting
Start date
September 24, 2020
Completion date
December 1, 2028
Enrollment
161 (actual)
Sites
115

Conditions

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

primary biliary cirrhosis