Not Yet RecruitingNot Applicable

Clinical Characterization of Patients With Primary Biliary Cirrhosis Treated With Seladelpar in the Real-life Setting

Germany100 participantsStarted 2026-04-01

Plain-language summary

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.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. Age ≥ 18 years
✓. Diagnosis of PBC according to EASL criteria
✓. Treatment with seladelpar
✓. Written informed consent

Exclusion criteria

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

What they're measuring

biochemical response according to POISE criteria

Timeframe: start of seladelpar therapy (week 0) until week 48 after start of seladelpar

Trial details

NCT IDNCT07549607

SponsorUniversity of Leipzig

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2028-04-01

Contact for this trial

Johannes Wiegand, Prof. Dr.

0049 341 97 12330 johannes.wiegand@medizin.uni-leipzig.de

View on ClinicalTrials.gov More Primary Bilary Cirrhosis (PBC) trials