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

NCT07549607 | Not Yet Recruiting

• 1 other identifier: Seladelpar registry
• Study Type: observational
• Target: 100
• Locations: 2 countries
• Sites: 21

Brief 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.

Conditions

Primary Bilary Cirrhosis (PBC)

Outcome Measures

Primary Outcomes (1)

• biochemical response according to POISE criteria

  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

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

Secondary Outcomes (11)

• alternative definitions of response at the 48 week visit for patients with ALP levels > 1.5 or > 1.0 x ULN or bilirubin levels > 1.0 or > 0.6 x ULN at week 0 of seladelpar therapy

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

• Improvement in Vibration Controlled Transient Elastography (VCTE)

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

• indication for seladelpar

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

• AEs and SAEs will be classified using the Medical Dictionary for Regulatory Activities (MedDRA)

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

• concomitant diseases

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

Study Arms (1)

patients with primary biliary cirrhosis treated with seladelpar

Patients with primary biliary cirrhosis treated with seladelpar will be included into the SEL registry. No interventions. Routine data is collected. The documentation of the routine data is carried out alongside with guideline recommended treatment intervals of the patients.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

patients with Primary Biliary Cholangitis (PBC) treated with seladelpar

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Leipzig: lead

Study Sites (21)

Charité - Universitätsmedizin Berlin Med. Klinik für Gastroenterologie, Infektiologie und Rheumatologie (CBF)

Berlin, 12200, Germany

Location

DRK Kliniken Berlin Mitte Klinik für Innere Medizin - Gastroenterologie, Hepatologie, Diabetologie, Angiologie und Abhängigkeitserkrankungen

Berlin, 13359, Germany

Location

Universitätsklinikum Frankfurt Medizinische Klinik I, Haus 11/Gastroenterologie

Frankfurt, 60590, Germany

Location

Asklepios Klinik St. Georg, Leberzentrum, IFI-Institut

Hamburg, 20099, Germany

Location

Klinik für Gastroenterologie, Hepatologie und Endokrinologie; Medizinische Hochschule Hannover

Hanover, 30625, Germany

Location

Universitätsklinikum Heidelberg; Medizinische Universitätsklinik Heidelberg, Innere Medizin IV

Heidelberg, 69120, Germany

Location

Gastroenterologische Gemeinschaftspraxis Dres. Felten/Hinz/Mittrop/Sandmann/Wallner

Herne, 44623, Germany

Location

Universitätsklinikum des Saarlandes, Klinik für Innere Medizin II, Gastroenterologie und Endokrinologie

Homburg, 66421, Germany

Location

Universitätsklinikum Jena; Klinik für Innere Medizin IV - Gastroenterologie, Hepatologie, Infektiologie

Jena, 07747, Germany

Location

GHZ - gastroenterologisch - hepatologisches MVZ Kiel GmbH

Kiel, 24105, Germany

Location

Universitätsklinikum Schleswig-Holstein; Campus Kiel Klinik für Innere Medizin I - Gastroenerologie, Hepatologie

Kiel, 24105, Germany

Location

Leipzig University, University Hospital Division of Hepatology, Department of Medicine II, Leipzig University Medical Center

Leipzig, 04103, Germany

Location

MVZ Gastroenterologie Leverkusen GbR

Leverkusen, 51375, Germany

Location

Universitätsklinikum Schleswig-Holstein, Campus Lübeck, Medizinische Klinik I

Lübeck, 23538, Germany

Location

LMU Klinikum, Leber Centrum München (LCM), Campus Großhadern

München, 81377, Germany

Location

Klinikum rechts der Isar der TU München, Medizinische Klinik und Poliklinik II

München, 81675, Germany

Location

Universitätsklinikum Münster, Medizinische Klinik B

Münster, 48149, Germany

Location

Klinikum Nürnberg Nord

Nuremberg, 90419, Germany

Location

Universitätsklinikum Tübingen, Medizinische Klinik I

Tübingen, 72076, Germany

Location

St. Josefs Hospital; Med. Klinik II: Gastroenterologie, Hepatologie

Wiesbaden, 65189, Germany

Location

Clinic for Gastroenterology and Hepatology; University Hospital Zürich

Zurich, 8091, Switzerland

Location

Central Study Contacts

Johannes Wiegand, Prof. Dr.

CONTACT

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Target Duration: 48 Weeks
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr.

Study Record Dates

• First Submitted: March 12, 2026
• First Posted: April 24, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): April 1, 2028
• Study Completion (Estimated): October 1, 2028
• Last Updated: April 24, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: After publication of the major results
• Access Criteria: 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.

Locations

CH (1); DE (20)