Clinical Characterization of Patients With Primary Biliary Cirrhosis Treated With Seladelpar in the Real-life Setting
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Primary Bilary Cirrhosis (PBC). Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Germany, Switzerland
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Primary outcome measures
- biochemical response according to POISE criteria [Time frame: start of seladelpar therapy (week 0) until week 48 after start of seladelpar]
Secondary outcome measures (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 [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.)]
Eligibility criteria
Inclusion criteria
- Age ≥ 18 years
- Diagnosis of PBC according to EASL criteria
- Treatment with seladelpar
- Written informed consent
Exclusion criteria
- current or previous participation in a phase I to IV interventional clinical trial for seladelpar treatment of PBC
- Pregnancy and breastfeeding
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Germany · 20 centers
- Charité - Universitätsmedizin Berlin Med. Klinik für Gastroenterologie, Infektiologie und — Berlin
- DRK Kliniken Berlin Mitte Klinik für Innere Medizin - Gastroenterologie, Hepatologie, Diab — Berlin
- Universitätsklinikum Frankfurt Medizinische Klinik I, Haus 11/Gastroenterologie — Frankfurt
- Asklepios Klinik St. Georg, Leberzentrum, IFI-Institut — Hamburg
- Klinik für Gastroenterologie, Hepatologie und Endokrinologie; Medizinische Hochschule Hann — Hanover
- Universitätsklinikum Heidelberg; Medizinische Universitätsklinik Heidelberg, Innere Medizi — Heidelberg
- Gastroenterologische Gemeinschaftspraxis Dres. Felten/Hinz/Mittrop/Sandmann/Wallner — Herne
- Universitätsklinikum des Saarlandes, Klinik für Innere Medizin II, Gastroenterologie und E — Homburg
- … and 12 more centers
Switzerland · 1 center
- Clinic for Gastroenterology and Hepatology; University Hospital Zürich — Zurich
Identifiers
NCT: NCT07549607 · Seladelpar registry