Trials Sponsors Conditions Drugs Pricing

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
+6 more secondary outcomes

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

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

Sampling MethodNon-Probability Sample

Study Population

patients with Primary Biliary Cholangitis (PBC) treated with seladelpar

You may qualify if:

Age ≥ 18 years

Sponsors & Collaborators

University of Leipzig
Otherlead

Study Sites (21)

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

Berlin, 12200, Germany

Marion Muche, Dr.CONTACTmarion.muche@charite.de

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

Berlin, 13359, Germany

Tobias MüllerCONTACTProf. Dr.t.mueller@drk-kliniken-berlin.de

Universitätsklinikum Frankfurt Medizinische Klinik I, Haus 11/Gastroenterologie

Frankfurt, 60590, Germany

Kathrin Sprinzl, Dr.

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

Estimated (date passed)

This estimate has passed. The registry has not confirmed an actual date for this milestone.

Primary Completion

April 1, 2028

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

Study Start

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (11)

Study Arms (1)

patients with primary biliary cirrhosis treated with seladelpar

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (21)

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

Study Start

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (11)

Study Arms (1)

patients with primary biliary cirrhosis treated with seladelpar

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (21)

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations