Study of Elafibranor in Patients With Primary Biliary Cholangitis (PBC) (ELATIVE)
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
Sponsor: Ipsen
A observational or N/A phase clinical study on Primary Biliary Cirrhosis, this trial is ongoing. The trial is conducted by Ipsen and has accumulated 44 data snapshots since 2020. Longitudinal tracking of this trial contributes to a broader understanding of treatment development timelines.
Status Flow
Change History
44 versions recorded-
May 4, 2026 — Present [daily]
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Phase: PHASE3 → None
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▶ Show 39 earlier versions
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Status: Recruiting → Active Not Recruiting
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Status: Not Yet Recruiting → Recruiting
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Oct 2020 — Nov 2020 [monthly]
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Sep 2020 — Oct 2020 [monthly]
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First recorded
Eligibility Summary
The participants of this study will have confirmed Primary Biliary Cholangitis (PBC) with inadequate response or intolerance to ursodeoxycholic acid (which is a medication used in the management and treatment of cholestatic liver disease). PBC is a slowly progressive disease characterized by damage of the bile ducts in the liver, leading to a buildup of bile acids which causes further damage. The liver damage in PBC may lead to scarring (cirrhosis). PBC may also be associated with multiple symptoms. Many patients with PBC may require liver transplant or may die if the disease progresses and a liver transplant is not done. The main aim of this study is to determine if elafibranor (the study drug) is better than placebo (a dummy treatment) at decreasing the levels of a specific blood test (alkaline phosphatase) that provides information about participant's disease. This study will also evaluate the safety of long-term treatment with elafibranor, as well as the impact on symptoms such as itchy skin (pruritus) and tiredness (fatigue). This study has two main parts: Part 1 will compare a daily dose of elafibranor to a daily dose of placebo and will last between a minimum of one year and a maximum of two years. Part 2, all participants will receive elafibranor for a period of up to 5 years or until the total treatment duration (part 1 and part 2) reaches 6 years, whichever occurs first.
Contact Information
- Ipsen
For direct contact, visit the study record on ClinicalTrials.gov .
Study Locations
Amiens, France , Ankara, Turkey (Türkiye) , Arlington, United States , Atlanta, United States , Aurora, United States , Barcelona, Spain , Barcelona, Spain , Belfast, United Kingdom , Berlin, Germany , Berlin, Germany and 105 more locations