A Study Observing Everyday Effectiveness and Safety of the Drug Elafibranor in Participants With Primary Biliary Cholangitis Who Are Receiving Ongoing Treatment (ELFINITY)
Prospective Non-interventional, Phase IV Multicentre Study to Assess the Effectiveness, Safety and Tolerability of Elafibranor 80 mg/Day in Participants With Primary Biliary Cholangitis Receiving Treatment in a Real-world Setting.
Sponsor: Ipsen
This observational or N/A phase trial investigates Primary Biliary Cholangitis and is currently actively recruiting participants. Ipsen leads this study, which shows 17 recorded versions since 2024 — indicating substantial longitudinal coverage. The change history captured here reflects the iterative nature of clinical trial conduct.
Status Flow
Change History
17 versions recorded-
May 4, 2026 — Present [daily]
Recruiting
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Mar 2026 — May 2026 [monthly]
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Feb 2026 — Mar 2026 [monthly]
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Jan 2026 — Feb 2026 [monthly]
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Nov 2025 — Jan 2026 [monthly]
Recruiting
▶ Show 12 earlier versions
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Oct 2025 — Nov 2025 [monthly]
Recruiting
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Sep 2025 — Oct 2025 [monthly]
Recruiting
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Jun 2025 — Sep 2025 [monthly]
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May 2025 — Jun 2025 [monthly]
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Mar 2025 — May 2025 [monthly]
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Feb 2025 — Mar 2025 [monthly]
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Jan 2025 — Feb 2025 [monthly]
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Dec 2024 — Jan 2025 [monthly]
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Nov 2024 — Dec 2024 [monthly]
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Oct 2024 — Nov 2024 [monthly]
Recruiting
Status: Not Yet Recruiting → Recruiting
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Sep 2024 — Oct 2024 [monthly]
Not Yet Recruiting
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Jul 2024 — Sep 2024 [monthly]
Not Yet Recruiting
First recorded
Eligibility Summary
This study will collect information from participants with Primary Biliary Cholangitis (PBC) as they use the drug elafibranor in real world setting. PBC is a progressive rare liver disease in which tubes in the liver called bile ducts are damaged. The liver damage in PBC may lead to scarring (cirrhosis). PBC may also be associated with multiple symptoms including pruritus (itching) and fatigue. Many patients with PBC may require liver transplant or may die if the disease progresses and a liver transplant is not done. In this study the main aim is to observe the effectiveness, safety and tolerability of elafibranor in participants with PBC who are receiving treatment in real world setting. The total study duration for each participants will be 60 months (approximately 5 years).
Contact Information
- Ipsen
For direct contact, visit the study record on ClinicalTrials.gov .
Study Locations
Aberdeen, United Kingdom , Almería, Spain , Athens, Greece , Barcelona, Spain , Barcelona, Spain , Belfast, United Kingdom , Bergamo, Italy , Berlin, Germany , Berlin, Germany , Birmingham, United Kingdom and 55 more locations