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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Primary Bilary Cirrhosis (PBC)

Detailed 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.

• Study Type: Observational
• Enrollment (Estimated): 100

Contacts and Locations

• Study Contact: Name: Johannes Wiegand, Prof. Dr.; Phone Number: 0049 341 97 12330; Email: johannes.wiegand@medizin.uni-leipzig.de

Study Locations

• Germany
  • Berlin, Germany, 12200
    • Charité - Universitätsmedizin Berlin Med. Klinik für Gastroenterologie, Infektiologie und Rheumatologie (CBF)
    • Contact: Marion Muche, Dr.; Email: marion.muche@charite.de
  • Berlin, Germany, 13359
    • DRK Kliniken Berlin Mitte Klinik für Innere Medizin - Gastroenterologie, Hepatologie, Diabetologie, Angiologie und Abhängigkeitserkrankungen
    • Contact: Tobias Müller; Phone Number: Prof. Dr.; Email: t.mueller@drk-kliniken-berlin.de
  • Frankfurt, Germany, 60590
    • Universitätsklinikum Frankfurt Medizinische Klinik I, Haus 11/Gastroenterologie
    • Contact: Kathrin Sprinzl, Dr.; Email: kathrin.sprinzl@unimedizin-ffm.de
  • Hamburg, Germany, 20099
    • Asklepios Klinik St. Georg, Leberzentrum, IFI-Institut
    • Contact: Peter Buggisch, Dr.; Email: Peter.Buggisch@amedes-group.com
  • Hanover, Germany, 30625
    • Klinik für Gastroenterologie, Hepatologie und Endokrinologie; Medizinische Hochschule Hannover
    • Contact: Heike Bantel, Prof. Dr.; Email: Bantel.Heike@mh-hannover.de
  • Heidelberg, Germany, 69120
    • Universitätsklinikum Heidelberg; Medizinische Universitätsklinik Heidelberg, Innere Medizin IV
    • Contact: Theresa Wenz, Dr.; Email: Theresa.Wenz@med.uni-heidelberg.de
  • Herne, Germany, 44623
    • Gastroenterologische Gemeinschaftspraxis Dres. Felten/Hinz/Mittrop/Sandmann/Wallner
    • Contact: Matthias Hinz, Dr.; Email: hinz@gashinz@gastro-praxis-herne.de
  • Homburg, Germany, 66421
    • Universitätsklinikum des Saarlandes, Klinik für Innere Medizin II, Gastroenterologie und Endokrinologie
    • Contact: Jörn Schattenberg, Prof. Dr.; Email: Joern.Schattenberg@uks.eu
  • Jena, Germany, 07747
    • Universitätsklinikum Jena; Klinik für Innere Medizin IV - Gastroenterologie, Hepatologie, Infektiologie
    • Contact: Philipp Reuken, Prof. Dr.; Email: PHILIPP.REUKEN@med.uni-jena.de
  • Kiel, Germany, 24105
    • GHZ - gastroenterologisch - hepatologisches MVZ Kiel GmbH
    • Contact: Holger Hinrichsen, PD Dr.; Email: holger.hinrichsen@gh-mvz-kiel.de
  • Kiel, Germany, 24105
    • Universitätsklinikum Schleswig-Holstein; Campus Kiel Klinik für Innere Medizin I - Gastroenerologie, Hepatologie
    • Contact: Rainer Günther; Phone Number: Dr.; Email: rguenther@1med.uni-kiel.de
  • Leipzig, Germany, 04103
    • Leipzig University, University Hospital Division of Hepatology, Department of Medicine II, Leipzig University Medical Center
    • Contact: Johannes Wiegand, Prof. Dr.; Phone Number: 0049 341 97 12 330; Email: johannes.wiegand@medizin.uni-leipzig.de
  • Leverkusen, Germany, 51375
    • MVZ Gastroenterologie Leverkusen GbR
    • Contact: Karl-Georg Simon, Dr.; Email: kg.simon@gastroenterologie-leverkusen.de
  • Lübeck, Germany, 23538
    • Universitätsklinikum Schleswig-Holstein, Campus Lübeck, Medizinische Klinik I
    • Contact: Jens Marquardt, Prof. Dr.; Email: Jens.Marquardt@uksh.de
  • München, Germany, 81377
    • LMU Klinikum, Leber Centrum München (LCM), Campus Großhadern
    • Contact: Gerhard Denk, Prof. Dr.; Email: Gerald.Denk@med.uni-muenchen.de
  • München, Germany, 81675
    • Klinikum rechts der Isar der TU München, Medizinische Klinik und Poliklinik II
    • Contact: Marc Ringalhan, Dr.; Email: Marc.Ringelhan@mri.tum.de
  • Münster, Germany, 48149
    • Universitätsklinikum Münster, Medizinische Klinik B
    • Contact: Jonel Trebicka, Prof. Dr.; Email: Jonel.Trebicka@ukmuenster.de
  • Nuremberg, Germany, 90419
    • Klinikum Nürnberg Nord
    • Contact: Andreas Weber, Dr.; Email: Andreas.Weber@klinikum-nuernberg.de
  • Tübingen, Germany, 72076
    • Universitätsklinikum Tübingen, Medizinische Klinik I
    • Contact: Christoph Berg, Prof. Dr.; Email: Christoph.Berg@med.uni-tuebingen.de
  • Wiesbaden, Germany, 65189
    • St. Josefs Hospital; Med. Klinik II: Gastroenterologie, Hepatologie
    • Contact: Christoph Sarrazin, Prof. Dr.; Email: CSarrazin@joho.de
• Switzerland
  • Zurich, Switzerland, 8091
    • Clinic for Gastroenterology and Hepatology; University Hospital Zürich
    • Contact: Andreas Kremer, Prof. Dr.; Email: andreas.kremer@usz.ch

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

patients with Primary Biliary Cholangitis (PBC) treated with seladelpar

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	ALP < 1.5 x ULN; ALP < 1.0 x ULN; bilirubin < 1.0 x ULN; bilirubin < 0.6 x ULN	start of seladelpar therapy (week 0) until week 48 after start of seladelpar
Improvement in Vibration Controlled Transient Elastography (VCTE)	Improvement in Vibration Controlled Transient Elastography (VCTE) as a surrogate for fibrosis. The mean individual relative change in VCTE values from week 0 to 48 weeks will be calculated. Furthermore, for patients with values above the cut-offs 8, 10 and 15 kPa at week 0, the proportion who then fall below these cut-offs will be provided.	start of seladelpar therapy (week 0) until week 48 after start of seladelpar
indication for seladelpar	The treating physician provides the indication for seladalpar as one of "biochemical response", "pruritus", "both".	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)	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	concomitant diseases as documented on every visit time point (week 0-4-8-12-24-36-48)	start of seladelpar therapy (week 0) until week 48 after start of seladelpar
concomitant medication classes	The following concomitant medication classes will be documented: fibrates, statins, anti-pruritic therapy. Details on particular medication and dosage may be collected and this list may be expanded.	start of seladelpar therapy (week 0) until week 48 after start of seladelpar
problems with pruritus	Patients will be asked to report if they have problems with pruritus. Units of Measure: mild, moderate or severe.	start of seladelpar therapy (week 0) until week 48 after start of seladelpar
questionnaire	Patients will be asked to filled out the Numeric Rating Scale (NRS) Pruritus (for average and worst itch assessment) questionnaire	start of seladelpar therapy (week 0) until week 48 after start of seladelpar (Questionnaires can only be collected prospectively. The number of questionnaires depends on the time of patient recruitment.)
questionnaire	Patients will be asked to filled out the PROMIS Fatigue Questionnaire questionnaire	start of seladelpar therapy (week 0) until week 48 after start of seladelpar (Questionnaires can only be collected prospectively. The number of questionnaires depends on the time of patient recruitment.)
questionnaire	Patients will be asked to filled out the PBC-40 questionnaire	start of seladelpar therapy (week 0) until week 48 after start of seladelpar (Questionnaires can only be collected prospectively. The number of questionnaires depends on the time of patient recruitment.)
questionnaire	Patients will be asked to filled out the Euro Quol (EQ)-5D questionnaire	start of seladelpar therapy (week 0) until week 48 after start of seladelpar (Questionnaires can only be collected prospectively. The number of questionnaires depends on the time of patient recruitment.)

Collaborators and Investigators

• Sponsor: University of Leipzig

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2026
• Primary Completion (Estimated): April 1, 2028
• Study Completion (Estimated): October 1, 2028

Study Registration Dates

• First Submitted: March 12, 2026
• First Submitted That Met QC Criteria: April 17, 2026
• First Posted (Actual): April 24, 2026

Study Record Updates

• Last Update Posted (Actual): April 24, 2026
• Last Update Submitted That Met QC Criteria: April 17, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: Seladelpar registry

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: According to the recommendations on data sharing by the International Committee of Medical Journal Editors (ICMJE) data resulting from the Seladelpar registry will be made available to the scientific community.
• IPD Sharing Time Frame: After publication of the major results

IPD Sharing 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.

• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No