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New drug seladelpar tracked in Real-Life PBC patients

NCT ID NCT07549607

Disease control Sponsor: University of Leipzig Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study will follow 100 adults with primary biliary cirrhosis (PBC) who are taking seladelpar in Germany and Switzerland. Researchers will collect real-world data to see if the drug helps improve liver function tests after 48 weeks. The goal is to understand how well seladelpar works outside of controlled clinical trials.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 100 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Apr 2026

An estimate. Start dates often move.

Expected to finish

Oct 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

patients with Primary Biliary Cholangitis (PBC) treated with seladelpar

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

primary biliary cholangitis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Primary bilary cirrhosis (PBC)

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    21 sites in 2 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Asklepios Klinik St. Georg, Leberzentrum, IFI-Institut

    Hamburg, 20099, Germany

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

    Berlin, 12200, Germany

  • Clinic for Gastroenterology and Hepatology; University Hospital Zürich

    Zurich, 8091, Switzerland

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

    Berlin, 13359, Germany

  • GHZ - gastroenterologisch - hepatologisches MVZ Kiel GmbH

    Kiel, 24105, Germany

  • Gastroenterologische Gemeinschaftspraxis Dres. Felten/Hinz/Mittrop/Sandmann/Wallner

    Herne, 44623, Germany

  • Klinik für Gastroenterologie, Hepatologie und Endokrinologie; Medizinische Hochschule Hannover

    Hanover, 30625, Germany

  • Klinikum Nürnberg Nord

    Nuremberg, 90419, Germany

  • Klinikum rechts der Isar der TU München, Medizinische Klinik und Poliklinik II

    München, 81675, Germany

  • LMU Klinikum, Leber Centrum München (LCM), Campus Großhadern

    München, 81377, Germany

  • Leipzig University, University Hospital Division of Hepatology, Department of Medicine II, Leipzig University Medical Center

    Leipzig, 04103, Germany

  • MVZ Gastroenterologie Leverkusen GbR

    Leverkusen, 51375, Germany

  • St. Josefs Hospital; Med. Klinik II: Gastroenterologie, Hepatologie

    Wiesbaden, 65189, Germany

  • Universitätsklinikum Frankfurt Medizinische Klinik I, Haus 11/Gastroenterologie

    Frankfurt, 60590, Germany

  • Universitätsklinikum Heidelberg; Medizinische Universitätsklinik Heidelberg, Innere Medizin IV

    Heidelberg, 69120, Germany

  • Universitätsklinikum Jena; Klinik für Innere Medizin IV - Gastroenterologie, Hepatologie, Infektiologie

    Jena, 07747, Germany

  • Universitätsklinikum Münster, Medizinische Klinik B

    Münster, 48149, Germany

  • Universitätsklinikum Schleswig-Holstein, Campus Lübeck, Medizinische Klinik I

    Lübeck, 23538, Germany

  • Universitätsklinikum Schleswig-Holstein; Campus Kiel Klinik für Innere Medizin I - Gastroenerologie, Hepatologie

    Kiel, 24105, Germany

  • Universitätsklinikum Tübingen, Medizinische Klinik I

    Tübingen, 72076, Germany

  • Universitätsklinikum des Saarlandes, Klinik für Innere Medizin II, Gastroenterologie und Endokrinologie

    Homburg, 66421, Germany