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NCT Number: NCT07549607

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

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.

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Key information

Conditions

Primary Bilary Cirrhosis (PBC)

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

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

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

    • ALP < 1.5 x ULN
    • ALP < 1.0 x ULN
    • bilirubin < 1.0 x ULN
    • bilirubin < 0.6 x ULN

  2. Improvement in Vibration Controlled Transient Elastography (VCTE)

    Time frame: start of seladelpar therapy (week 0) until week 48 after start of seladelpar

    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.

  3. indication for seladelpar

    Time frame: start of seladelpar therapy (week 0) until week 48 after start of seladelpar

    The treating physician provides the indication for seladalpar as one of "biochemical response", "pruritus", "both".

  4. 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

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

  5. concomitant diseases

    Time frame: start of seladelpar therapy (week 0) until week 48 after start of seladelpar

    concomitant diseases as documented on every visit time point (week 0-4-8-12-24-36-48)

  6. concomitant medication classes

    Time frame: start of seladelpar therapy (week 0) until week 48 after start of seladelpar

    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.

  7. problems with pruritus

    Time frame: start of seladelpar therapy (week 0) until week 48 after start of seladelpar

    Patients will be asked to report if they have problems with pruritus. Units of Measure: mild, moderate or severe.

  8. 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.)

    Patients will be asked to filled out the Numeric Rating Scale (NRS) Pruritus (for average and worst itch assessment) questionnaire

  9. 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.)

    Patients will be asked to filled out the PROMIS Fatigue Questionnaire questionnaire

  10. 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.)

    Patients will be asked to filled out the PBC-40 questionnaire

  11. 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.)

    Patients will be asked to filled out the Euro Quol (EQ)-5D questionnaire

Study contacts

Contact information is provided by the study sponsor or research team.

Johannes Wiegand, Prof. Dr.

CONTACT

[email protected]

0049 341 97 12330

Sponsors and collaborators

Lead sponsor

University of Leipzig

Other

Registry information

Acronym: SENSE registry

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Apr 24, 2026
Registry last updated
Apr 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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