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

NCT07549607 · tracked via the Priya Life Science Germany tracker

Sponsor

University of Leipzig

Phase

Observational

Started

2026-04-01

Last updated

2026-04-24

Condition(s) studied

Primary Bilary Cirrhosis (PBC)

Study 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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

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

Primary outcome measure(s)

biochemical response according to POISE criteria — start of seladelpar therapy (week 0) until week 48 after start of seladelpar
The endpoint "POISE criteria" is reached if at the 48 week visit, ALP \< 1.67 x ULN and at least 15% lower than week 0 value from the start of seladelpar

Trial sites (21)

Facility	City	Region
Charité - Universitätsmedizin Berlin Med. Klinik für Gastroenterologie, Infektiologie und Rheumatologie (CBF)	Berlin	Germany
DRK Kliniken Berlin Mitte Klinik für Innere Medizin - Gastroenterologie, Hepatologie, Diabetologie, Angiologie und Abhängigkeitserkrankungen	Berlin	Germany
Universitätsklinikum Frankfurt Medizinische Klinik I, Haus 11/Gastroenterologie	Frankfurt	Germany
Asklepios Klinik St. Georg, Leberzentrum, IFI-Institut	Hamburg	Germany
Klinik für Gastroenterologie, Hepatologie und Endokrinologie; Medizinische Hochschule Hannover	Hanover	Germany
Universitätsklinikum Heidelberg; Medizinische Universitätsklinik Heidelberg, Innere Medizin IV	Heidelberg	Germany
Gastroenterologische Gemeinschaftspraxis Dres. Felten/Hinz/Mittrop/Sandmann/Wallner	Herne	Germany
Universitätsklinikum des Saarlandes, Klinik für Innere Medizin II, Gastroenterologie und Endokrinologie	Homburg	Germany
Universitätsklinikum Jena; Klinik für Innere Medizin IV - Gastroenterologie, Hepatologie, Infektiologie	Jena	Germany
GHZ - gastroenterologisch - hepatologisches MVZ Kiel GmbH	Kiel	Germany
Universitätsklinikum Schleswig-Holstein; Campus Kiel Klinik für Innere Medizin I - Gastroenerologie, Hepatologie	Kiel	Germany
Leipzig University, University Hospital Division of Hepatology, Department of Medicine II, Leipzig University Medical Center	Leipzig	Germany
MVZ Gastroenterologie Leverkusen GbR	Leverkusen	Germany
Universitätsklinikum Schleswig-Holstein, Campus Lübeck, Medizinische Klinik I	Lübeck	Germany
LMU Klinikum, Leber Centrum München (LCM), Campus Großhadern	München	Germany
Klinikum rechts der Isar der TU München, Medizinische Klinik und Poliklinik II	München	Germany
Universitätsklinikum Münster, Medizinische Klinik B	Münster	Germany
Klinikum Nürnberg Nord	Nuremberg	Germany
Universitätsklinikum Tübingen, Medizinische Klinik I	Tübingen	Germany
St. Josefs Hospital; Med. Klinik II: Gastroenterologie, Hepatologie	Wiesbaden	Germany
Clinic for Gastroenterology and Hepatology; University Hospital Zürich	Zurich	Switzerland

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07549607 on ClinicalTrials.gov ↗ ← All trials in Germany