What is this study trying to find out about Primary Biliary Cholangitis (PBC)?

This study is collecting information on how patients with PBC use the drug elafibranor in everyday medical care. Researchers want to understand the drug's effectiveness, safety, and tolerability in a real-world setting. The study is sponsored by Ipsen and aims to help improve knowledge about PBC treatment outcomes.

Who may be eligible for this Primary Biliary Cholangitis clinical trial?

Adults with a diagnosis of PBC who are starting or already receiving elafibranor treatment may be eligible. Participants must be able to give informed consent and not be involved in other investigational drug or device studies. There are no gender or age restrictions for this study. Please review eligibility criteria for more details.

Is there any cost to participate in this Primary Biliary Cholangitis clinical trial?

Study-related care, including the study drug and all trial visits, is provided at no cost. However, personal travel and other expenses may vary and are not guaranteed to be covered by the study.

Actively Recruiting

All Genders

ID06447168

Prospective Non-interventional Multicentre Study to Assess Effectiveness, Safety, and Tolerability of Elafibranor 80 mgDay in Primary Biliary Cholangitis Patients in Real-World Treatment

Led by Ipsen · Updated on 2026-05-28

424

Participants Needed

Research Sites

N/A

Total Duration

AI-Summary

What this Trial Is About

Researchers are observing the real-world use of the drug elafibranor in people with Primary Biliary Cholangitis PBC, a rare progressive liver disease where bile ducts are damaged. This damage can cause liver scarring and symptoms like itching and fatigue. The study aims to collect information on how effective, safe, and tolerable elafibranor is for PBC patients receiving ongoing treatment. Each participant will be part of the study for about 5 years. Participants will continue their treatment with elafibranor as prescribed by their doctors while researchers gather data without altering care. The study monitors participants over a 60-month period, collecting information during routine physician follow-up visits. There is no placebo or comparison group since this is an observational study focusing on real-world use of elafibranor. During the study, researchers will track treatment response at 6 months and follow liver function tests, symptom changes like itching and fatigue, quality of life, liver stiffness, and safety measures up to 5 years. They will also assess participant satisfaction and adherence to treatment. Data is collected during regular medical visits, making participation flexible and integrated with usual care.

CONDITIONS

Brief Title

A Study Observing Everyday Effectiveness and Safety of the Drug Elafibranor in Participants With Primary Biliary Cholangitis Who Are Receiving Ongoing Treatment

Who Can Participate

All Genders

Eligibility Criteria

You may qualify if you...

Participant has provided written informed consent and agrees to comply with the study protocol.
Participant has a diagnosis of Primary Biliary Cholangitis (PBC).
Participant is starting or currently receiving treatment with commercially available elafibranor.
If applicable, caregiver consents to complete caregiver questionnaires before data collection.

You will not qualify if you...

Participant is currently enrolled or plans to enroll in another investigational drug or medical device study.
Participant has known hypersensitivity to elafibranor or any of its ingredients.
Participant has mental instability or incompetence that may affect informed consent validity or study compliance.

Research Team

Ipsen Clinical Study Enquiries

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