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Observing the effectiveness and safety of elafibranor in patients with Primary Biliary Cholangitis

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.

Observational Ipsen · NCT06447168

This study is testing how well and safely the drug elafibranor works for people with Primary Biliary Cholangitis over two years.

Quick facts

Study typeObservational
Enrollment424 (estimated)
SexAll
SponsorIpsen Industry-sponsored
Locations65 sites (Coronado, California and 64 other locations)
Trial IDNCT06447168 on ClinicalTrials.gov

What this trial studies

This observational study aims to collect real-world data on the effectiveness, safety, and tolerability of the drug elafibranor in patients diagnosed with Primary Biliary Cholangitis (PBC). Participants who are naïve to elafibranor and have been prescribed the drug by their treating physician will be monitored over a 24-month period. The study will gather information on how elafibranor performs in everyday clinical settings, providing insights into its impact on the progression of PBC. The findings could help inform treatment decisions and improve patient outcomes.

Who should consider this trial

Good fit: Ideal candidates for this study are individuals diagnosed with Primary Biliary Cholangitis who are starting treatment with elafibranor for the first time.

Not a fit: Patients who have previously started elafibranor treatment or those with known hypersensitivity to the drug will not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide valuable information on the real-world effectiveness of elafibranor, potentially leading to improved management of Primary Biliary Cholangitis.

How similar studies have performed: While this study focuses on real-world effectiveness, similar observational studies have shown promise in understanding treatment impacts in chronic conditions.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* Participant has provided written informed consent and agrees to comply with the study protocol.
* Participant with PBC diagnosis.
* Participant for whom the treating physician has decided to start or participants who are currently receiving treatment with commercialized elafibranor.
* If a participant has a caregiver who agrees to complete the caregiver questionnaires, an informed consent should be collected from the caregiver before any data is collected.

Exclusion Criteria:

* Participant is currently participating or, plans to participate in an investigational drug study or medical device study containing active substance.
* Participant with known hypersensitivity to the product or to any of its excipients.
* Participant with mental instability or incompetence, such that the validity of informed consent or ability to be compliant with the study is uncertain.

Where this trial is running

Coronado, California and 64 other locations

+15 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Primary Biliary Cholangitis
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.