Clinical Characterization of Patients With Primary Biliary Cirrhosis Treated With Seladelpar in the Real-life Setting
Conditions:
Primary Bilary Cirrhosis (PBC)
Sponsor: University of Leipzig
trial.available_in:
БГ
Overview
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.
Description
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.
Who can participate
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
Locations
21
Germany (20)
Charité - Universitätsmedizin Berlin Med. Klinik für Gastroenterologie, Infektiologie und Rheumatologie (CBF)
БГ