Study on the Long-Term Safety of Seladelpar for Patients with Primary Biliary Cholangitis

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What is this study about?

This clinical trial is focused on studying the disease known as Primary Biliary Cholangitis (PBC). PBC is a chronic liver disease that slowly destroys the bile ducts in the liver. The treatment being tested in this study is a medication called Seladelpar, which is taken in capsule form. The study will use two different dosages of Seladelpar: 50 mg and 100 mg capsules. The purpose of the study is to evaluate the long-term safety and tolerability of Seladelpar in individuals with PBC.

Participants in the study will take Seladelpar orally, which means they will swallow the capsules. The study will monitor participants over a period to observe any side effects or changes in their health. This will help researchers understand how well people tolerate the medication over time. The study will also collect information on various health markers, such as liver function tests, to see how the medication affects the body.

Throughout the study, participants will have regular check-ups to ensure their safety and to gather necessary data. The study aims to provide valuable information on the use of Seladelpar for treating PBC, contributing to the understanding of its long-term effects and potential benefits for individuals with this condition.

1 joining the study

Participation begins after providing informed consent, which involves signing and dating a document that confirms understanding and agreement to participate in the study.

Eligibility requires previous participation in a study involving seladelpar for primary biliary cholangitis (PBC) or completion of a future study that allows continuation into this trial.

2 medication administration

The medication seladelpar is administered orally in the form of a capsule.

The dosage and frequency of administration are determined by the study protocol and are designed to evaluate the long-term safety and tolerability of the medication.

3 safety and health monitoring

Regular monitoring of health and safety is conducted throughout the study. This includes collecting data on any adverse effects, as well as biochemistry and hematology results.

The study aims to identify any treatment-emergent adverse events using established criteria.

4 evaluation of clinical outcomes

The study evaluates specific clinical outcomes related to PBC, such as overall survival, liver transplantation needs, and other liver-related health issues.

Biochemical markers are assessed, including changes in alkaline phosphatase (ALP), aspartate aminotransferase (AST), alanine aminotransferase (ALT), gamma-glutamyl transferase (GGT), and bilirubin levels.

5 completion of the study

The study is estimated to conclude by February 28, 2026.

Participants are required to continue using effective birth control methods for at least 90 days after the last dose of seladelpar.

Who Can Join the Study?

Must have given informed consent, which means you have signed and dated a document agreeing to participate in the study after being informed about it.
Must have participated in a previous study related to Primary Biliary Cholangitis (PBC) with the medication seladelpar, or be part of a current or future study that allows you to join this one.
If you are a female who can have children, you must use at least one barrier method of birth control, like a condom, and another effective method during the study and for at least 90 days after the last dose of the study medication.
If you are a male who is sexually active with a female partner who can have children, you must use a barrier method of birth control, and your partner must use another effective method during the study and for at least 90 days after the last dose of the study medication.

Who Cannot Join the Study?

Patients who have any other serious liver disease besides Primary Biliary Cholangitis (a condition where the bile ducts in the liver are slowly destroyed).
Patients who have had a liver transplant.
Patients with severe heart problems.
Patients with uncontrolled diabetes (a condition where blood sugar levels are too high).
Patients with a history of cancer in the last 5 years, except for some skin cancers.
Patients who are pregnant or breastfeeding.
Patients who are currently participating in another clinical trial.
Patients who have a known allergy to the study medication or similar drugs.
Patients with any condition that the study doctors believe would make it unsafe for them to participate.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Uniwersyteckie Centrum Kliniczne Im. Prof. K. Gibinskiego Slaskiego Uniwersytetu Medycznego W Katowicach	Katowice	Poland
Gastroenterologische Gemeinschaftspraxis Herne	Herne	Germany
Katholieke Universiteit te Leuven	Leuven	Belgium

Other Sites

Site Name	City	Country
Azienda Ospedaliero Universitaria Di Modena	Modena	Italy
Universitair Ziekenhuis Gent	Gent	Belgium
Hospital Universitario 12 De Octubre	Madrid	Spain
Klinikum Wels-Grieskirchen GmbH	Wels	Austria
Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone	Palermo	Italy
Fondazione IRCCS San Gerardo Dei Tintori	Monza	Italy
General University Hospital Of Larissa	Larissa	Greece
ID Clinic	Myslowice	Poland
Somogy Varmegyei Kaposi Mor Oktato Korhaz	Kaposvar	Hungary
Institutul Clinic Fundeni	Bucharest	Romania
Universitaetsklinikum Erlangen AöR	Erlangen	Germany
Universitaetsklinikum Tuebingen AöR	Tuebingen	Germany
Hospital Clinic De Barcelona	Barcelona	Spain
Charite Universitaetsmedizin Berlin KöR	Berlin	Germany
Semmelweis University	Budapest	Hungary
Stichting Radboud University Medical Center	Nijmegen	The Netherlands
Centre Hospitalier Lyon Sud	Pierre Benite	France
Hopital Beaujon	Clichy	France
University Hospital Ostrava	Ostrava	Czechia
Hospital Universitario Virgen De La Victoria	Malaga	Spain
Hsikwyzp Urcwartccorcr Mvejbjm Dx Vlymkamzax	Santander	Spain
Goyzizhphsnbpvvluivqaalsrdwkwmncwsv Mmp Kniu Gnil	Kiel	Germany
ifueecgpasy Getl	Hamburg	Germany
Fqvazeyzi Pvve Lu Ixokufapjeinh Bfcjtfhtc Dur Htghkohk Urwtpcqrrlqug Lb Pta	Madrid	Spain
Hhlcwrpj Ufsrgajumeour Hzqhfoud Twkbc y Pevaep Ikabfpgj Cctgle dcoazbsoizzxbepez (dfko	Badalona	Spain
Huazoefz Vnfd dtqhofva	Barcelona	Spain

Trial status

Country	Status	Recruitment Start
Austria	Not recruiting	08.03.2021
Belgium	Not recruiting	08.03.2021
Czechia	Not recruiting	08.03.2021
France	Not recruiting	08.03.2021
Germany	Not recruiting	08.03.2021
Greece	Not recruiting	08.03.2021
Hungary	Not recruiting	08.03.2021
Italy	Not recruiting	08.03.2021
Poland	Not recruiting	08.03.2021
Romania	Not recruiting	08.03.2021
Spain	Not recruiting	08.03.2021
The Netherlands	Not recruiting	08.03.2021

Trial locations

Investigated drugs:

Seladelpar

Seladelpar is a medication being studied for its safety and tolerability in people with a liver condition called Primary Biliary Cholangitis (PBC). This condition affects the bile ducts in the liver, and seladelpar is being tested to see if it can be used safely over a long period to help manage this disease.

Primary Biliary Cholangitis – This is a chronic disease that slowly damages the bile ducts in the liver. Over time, the bile ducts become inflamed and are gradually destroyed, leading to a buildup of bile in the liver. This accumulation can cause liver damage and scarring, known as cirrhosis. The disease often progresses slowly, and symptoms may not appear until significant liver damage has occurred. Common symptoms include fatigue, itchy skin, and dry eyes and mouth. As the disease advances, it can lead to more severe liver problems.

Trial ID:

2024-511753-22-00

Protocol code:

CB8025-31731-RE

NCT ID:

NCT03301506

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on the Long-Term Safety of Seladelpar for Patients with Primary Biliary Cholangitis

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