Clinical Research Directory

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).