Primary Bilary Cirrhosis (PBC)SENSE registryNCT07549607
Clinical Characterization of Patients With Primary Biliary Cirrhosis Treated With Seladelpar in the Real-life Setting
An observational study of Primary Bilary Cirrhosis (PBC), run by University of Leipzig at 21 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Primary Bilary Cirrhosis (PBC)
- How many people
- 100 participants
- Where
- 21 sitesin 2 countries
- Study dates
- 1 Apr 2026to 1 Oct 2028
- How long will I take part?
- 48 Weeks
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients with Primary Biliary Cholangitis (PBC) treated with seladelpar
Who may be able to join
- Age ≥ 18 years
- Diagnosis of PBC according to EASL criteria
- Treatment with seladelpar
- Written informed consent
Who cannot join
- current or previous participation in a phase I to IV interventional clinical trial for seladelpar treatment of PBC
- Pregnancy and breastfeeding
Trial locations and contacts
21 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
21 sites in 2 countries
Germany20 sites
Charité - Universitätsmedizin Berlin Med. Klinik für Gastroenterologie, Infektiologie und Rheumatologie (CBF)
Berlin, 12200
Marion Muche, Dr., marion.muche@charite.de
DRK Kliniken Berlin Mitte Klinik für Innere Medizin - Gastroenterologie, Hepatologie, Diabetologie, Angiologie und Abhängigkeitserkrankungen
Berlin, 13359
Tobias Müller, Prof. Dr., t.mueller@drk-kliniken-berlin.de
Universitätsklinikum Frankfurt Medizinische Klinik I, Haus 11/Gastroenterologie
Frankfurt, 60590
Kathrin Sprinzl, Dr., kathrin.sprinzl@unimedizin-ffm.de
Asklepios Klinik St. Georg, Leberzentrum, IFI-Institut
Hamburg, 20099
Peter Buggisch, Dr., Peter.Buggisch@amedes-group.com
Klinik für Gastroenterologie, Hepatologie und Endokrinologie; Medizinische Hochschule Hannover
Hanover, 30625
Heike Bantel, Prof. Dr., Bantel.Heike@mh-hannover.de
Universitätsklinikum Heidelberg; Medizinische Universitätsklinik Heidelberg, Innere Medizin IV
Heidelberg, 69120
Theresa Wenz, Dr., Theresa.Wenz@med.uni-heidelberg.de
Gastroenterologische Gemeinschaftspraxis Dres. Felten/Hinz/Mittrop/Sandmann/Wallner
Herne, 44623
Matthias Hinz, Dr., hinz@gashinz@gastro-praxis-herne.de
Universitätsklinikum des Saarlandes, Klinik für Innere Medizin II, Gastroenterologie und Endokrinologie
Homburg, 66421
Jörn Schattenberg, Prof. Dr., Joern.Schattenberg@uks.eu
Universitätsklinikum Jena; Klinik für Innere Medizin IV - Gastroenterologie, Hepatologie, Infektiologie
Jena, 07747
Philipp Reuken, Prof. Dr., PHILIPP.REUKEN@med.uni-jena.de
GHZ - gastroenterologisch - hepatologisches MVZ Kiel GmbH
Kiel, 24105
Holger Hinrichsen, PD Dr., holger.hinrichsen@gh-mvz-kiel.de
Universitätsklinikum Schleswig-Holstein; Campus Kiel Klinik für Innere Medizin I - Gastroenerologie, Hepatologie
Kiel, 24105
Rainer Günther, Dr., rguenther@1med.uni-kiel.de
Leipzig University, University Hospital Division of Hepatology, Department of Medicine II, Leipzig University Medical Center
Leipzig, 04103
Johannes Wiegand, Prof. Dr., 0049 341 97 12 330, johannes.wiegand@medizin.uni-leipzig.de
MVZ Gastroenterologie Leverkusen GbR
Leverkusen, 51375
Karl-Georg Simon, Dr., kg.simon@gastroenterologie-leverkusen.de
Universitätsklinikum Schleswig-Holstein, Campus Lübeck, Medizinische Klinik I
Lübeck, 23538
Jens Marquardt, Prof. Dr., Jens.Marquardt@uksh.de
LMU Klinikum, Leber Centrum München (LCM), Campus Großhadern
München, 81377
Gerhard Denk, Prof. Dr., Gerald.Denk@med.uni-muenchen.de
Klinikum rechts der Isar der TU München, Medizinische Klinik und Poliklinik II
München, 81675
Marc Ringalhan, Dr., Marc.Ringelhan@mri.tum.de
Universitätsklinikum Münster, Medizinische Klinik B
Münster, 48149
Jonel Trebicka, Prof. Dr., Jonel.Trebicka@ukmuenster.de
Klinikum Nürnberg Nord
Nuremberg, 90419
Andreas Weber, Dr., Andreas.Weber@klinikum-nuernberg.de
Universitätsklinikum Tübingen, Medizinische Klinik I
Tübingen, 72076
Christoph Berg, Prof. Dr., Christoph.Berg@med.uni-tuebingen.de
St. Josefs Hospital; Med. Klinik II: Gastroenterologie, Hepatologie
Wiesbaden, 65189
Christoph Sarrazin, Prof. Dr., CSarrazin@joho.de
Switzerland1 site
Clinic for Gastroenterology and Hepatology; University Hospital Zürich
Zurich, 8091
Andreas Kremer, Prof. Dr., andreas.kremer@usz.ch
About this study
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.
Read the 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.
- Conditions
- Primary Bilary Cirrhosis (PBC)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
- ALP < 1.5 x ULN
- ALP < 1.0 x ULN
- bilirubin < 1.0 x ULN
- bilirubin < 0.6 x ULN
Measured: 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.
Measured: 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".
Measured: 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)
Measured: 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)
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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.)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2026
- Study start1 Apr 2026 (estimated)
- Primary completion1 Apr 2028 (estimated)
- Study completion1 Oct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary Bilary Cirrhosis (PBC)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 100 participants (estimated)
- Target duration
- 48 Weeks
Sponsor and investigators
- Lead sponsor
- University of Leipzig
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Johannes Wiegand, University of Leipzig
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07549607
- Sponsor's protocol ID
- Seladelpar registry
- Acronym
- SENSE registry
- Status last verified
- Apr 2026
- First submitted
- 12 Mar 2026
- Last updated
- 24 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Characterization of Patients With Primary Biliary Cirrhosis Treated With Seladelpar in the Real-life Setting
- ClinicalTrials.gov ID
- NCT07549607
- Acronym / sponsor ID
- SENSE registry / Seladelpar registry
- Conditions
- Primary Bilary Cirrhosis (PBC)
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of LeipzigUniversity, hospital or other
- Study start
- 1 Apr 2026 (estimated)
- Primary completion
- 1 Apr 2028 (estimated)
- Study completion
- 1 Oct 2028 (estimated)
- First posted
- 24 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 48 Weeks
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients with Primary Biliary Cholangitis (PBC) treated with seladelpar
Key inclusion criteria (4 listed)
- Age ≥ 18 years
- Diagnosis of PBC according to EASL criteria
- Treatment with seladelpar
- Written informed consent
Key exclusion criteria (2 listed)
- current or previous participation in a phase I to IV interventional clinical trial for seladelpar treatment of PBC
- Pregnancy and breastfeeding
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
biochemical response according to POISE criteria
Time frame: 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
11 secondary outcomes
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
Time frame: start of seladelpar therapy (week 0) until week 48 after start of seladelpar
Improvement in Vibration Controlled Transient Elastography (VCTE)
Time frame: start of seladelpar therapy (week 0) until week 48 after start of seladelpar
indication for seladelpar
Time frame: 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)
Time frame: start of seladelpar therapy (week 0) until week 48 after start of seladelpar
concomitant diseases
Time frame: start of seladelpar therapy (week 0) until week 48 after start of seladelpar
concomitant medication classes
Time frame: start of seladelpar therapy (week 0) until week 48 after start of seladelpar
problems with pruritus
Time frame: start of seladelpar therapy (week 0) until week 48 after start of seladelpar
questionnaire
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2026.
- Individual participant dataSharing planned: Yes. 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.
Related trials for Primary Bilary Cirrhosis (PBC)
Active, not recruitingPhase 3
Study of Elafibranor in Patients With Primary Biliary Cholangitis (PBC)
Primary Biliary Cirrhosis
RecruitingPhase 3
Seladelpar in Subjects With Primary Biliary Cholangitis (PBC) and Compensated Cirrhosis
Primary Biliary Cholangitis
RecruitingPhase 3
FIREFLY Trial: Fenofibrate Intervention---Randomized Evaluation in First-Line PBC Therapy
Primary Biliary Cholangitis (PBC)
RecruitingPhase 3
Fenofibrate for Patients With Primary Biliary Cirrhosis Who Had An Inadequate Response to Ursodeoxycholic Acid
Primary Biliary Cirrhosis
RecruitingPhase 2/3
Fenofibrate in Patients With Primary Biliary Cholangitis (PBC)
Primary Biliary Cholangitis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
21 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Primary Bilary Cirrhosis (PBC), run by University of Leipzig at 21 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 24 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 21 sites in Germany, Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Johannes Wiegand, Prof. Dr. (0049 341 97 12330, johannes.wiegand@medizin.uni-leipzig.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
biochemical response according to POISE criteria (time frame: start of seladelpar therapy (week 0) until week 48 after start of seladelpar). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2026.