NCT07906639Not yet recruiting
A Study of Fatigue, Itching and Daily Activities in People With Primary Biliary Cholangitis Starting Elafibranor
Prospective Observational Study Assessing the Impact of Elafibranor on Fatigue, Work Productivity/Activity Impairment, and Pruritus in Patients With PBC
Source: ClinicalTrials.gov · Last updated 30 Oct 2026
Brief summary (registry, in English)
The purpose of this study is to understand how tiredness changes in adults with Primary Biliary Cholangitis (PBC) after starting elafibranor in routine clinical practice. PBC is a rare liver disease that damages the small bile ducts in the liver. Participants will complete questionnaires before starting elafibranor and at Months 3, 6 and 12. The questionnaires will ask about tiredness, itching, work and daily activities. Each participant will be followed for approximately 12 months.
- Status (registry)
- Not yet recruiting
- Study type
- Observational
- Enrollment
- 50 (estimated)
- First submitted
- 7 Oct 2026
- Start date
- 2 Nov 2026
- Primary completion date
- 21 Aug 2028
- Lead sponsor
- Ipsen
- Diseases
- Primary biliary cholangitis
- NCT number
- NCT07906639
What you commit to
- Study type: Observational
- Planned participants: 50
- From 2 Nov 2026 to the primary completion date, 21 Aug 2028
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Failure to complete required baseline ePRO assessments (PBC-40 and PROMIS Fatigue SF-7a).
Other
- Unable to read and/or self-complete electronic ePRO instruments or do not have a designee available to complete ePROs on their behalf.
- Do not have access to a device on which ePRO instruments can be completed.
- Self-reported participation in an interventional trial in PBC at the time of screening.
Who the study is looking for
- Initial Screening Criteria (self-report)
- Self-reported diagnosis of PBC.
- Age ≥18 years at the time of screening.
- Self-reported treatment plan to initiate elafibranor, with no prior dose received before screening.
- Completion of the PBC-40 Fatigue Domain at the time of screening.
- Stratified enrollment targets will be applied, see Section 5.2 (Enrollment Targets) for the target distribution and operational management.
- Provided signed informed consent and medical record release authorization prior to data collection.
- Full Enrollment Criteria (confirmed via medical record review)
- Medical-record confirmed diagnosis of PBC.
- Documented prescription or treatment plan to initiate elafibranor and has not received a prior dose of elafibranor before enrollment.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.