The seladelpar registry will collect real-world data of patients with PBC diagnosis treated with seladelpar in the real-life scenario in Germany and Switzerland.

The seladelpar registry will offer data acquisition at weeks 0 - 4 - 8 - 12 - 24 - 36 - 48 of seladelpar treatment. Patients can be recruited either retro- or prospectively. The seladelpar registry will be an interim project until the start of the PBC 2.0 registry. Patients within the seladelpar registry will be characterized in detail with drug specific aspects, before it will be offered to transfer data for a long-term follow-up in the German PBC 2.0 registry if patients agree to this procedure in an upcoming informed consent process once the PBC 2.0 registry will be initiated.

Inclusion Criteria:

1. Age ≥ 18 years
2. Diagnosis of PBC according to EASL criteria
3. Treatment with seladelpar
4. Written informed consent

Exclusion Criteria:

1. current or previous participation in a phase I to IV interventional clinical trial for seladelpar treatment of PBC
2. Pregnancy and breastfeeding

patients with Primary Biliary Cholangitis (PBC) treated with seladelpar

According to the recommendations on data sharing by the International Committee of Medical Journal Editors (ICMJE) data resulting from the Seladelpar registry will be made available to the scientific community.

After publication of the major results

After publication of the major results and upon reasonable request from researchers performing an individual patient data meta-analysis, individual patient data that underlie published results will be shared after de-identification. This requires approval by the local ethics committee of the researcher requesting the data along with public registration of the meta-analysis. The coordinating investigator will contact the data protection officer before de-identification to ensure a correct and actual implementation of this process.

Summary statistics that go beyond the scope of published material will be made available to researchers for meta-analysis upon reasonable request and if the necessary data analysis is not unduly time-consuming. Together with publication of the main results, the observation plan in full will be made publically available as well as the statistical analysis plan.