Using Fenofibrate with Ursodeoxycholic Acid for Primary Biliary Cholangitis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study evaluates the safety and tolerability of fenofibrate in combination with ursodeoxycholic acid for patients with Primary Biliary Cholangitis (PBC). It is an open-label, long-term intervention designed to gather real-world data on the effectiveness of this treatment regimen. Participants must have previously completed a related PBC study involving fenofibrate and meet specific health criteria. The study aims to provide insights into the management of PBC through this combination therapy.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Must have given written informed consent (signed and dated)
2. Completed in a PBC study with fenofibrate(NCT05749822,NCT06174402)
3. ALP\> 1\*ULN
4. Females of reproductive potential must use at least one barrier contraceptive and a second effective birth control method during the study and for at least 90 days after the last dose. Male subjects who are sexually active with female partners of reproductive potential must use barrier contraception and their female partners must use a second effective birth control method during the study and for at least 90 days after the last dose

Exclusion Criteria:

1. Treatment-related adverse event (AE) leading to study drug discontinuation in a previous PBC study with seladelpar
2. A medical condition, other than PBC, that in the Investigator's opinion would preclude full participation in the study or confound its results

Where it's running

• Xijing hospital
  Xi'an, Shaanxi, China Recruiting

Study contacts

• Study coordinator: Yansheng Liu
• Email: liuyansheng506@163.com
• Phone: 862984771509

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Fenofibrate versus UDCA for first-line treatment of primary biliary cholangitis

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• Early detection of primary biliary cholangitis in people with positive AMA and normal ALP

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• Multimodal prehabilitation to reduce fatigue in primary biliary cholangitis

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• Long-term outcomes of primary biliary cholangitis in China

  This project will follow about 4,000 people in China with primary biliary cholangitis to see how symptoms, disease stage, and treatments affect long-term survival.

  Recruiting Beijing Friendship Hospital · Beijing, Select A State Or Province · NCT07149675

• Registry for autoimmune and cholestatic liver diseases in Spain

  This study is collecting information from patients with liver diseases in Spain to better understand these conditions and improve care for those affected.

  Recruiting Asociación Española para el Estudio del Hígado · Barcelona · NCT06767605

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.