A Study of Fatigue, Itching and Daily Activities in People With Primary Biliary Cholangitis Starting Elafibranor

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.

Inclusion Criteria: 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. Exclusion Criteria: * 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. * Failure to complete required baseline ePRO assessments (PBC-40 and PROMIS Fatigue SF-7a).