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 combining fenofibrate with ursodeoxycholic acid in patients with Primary Biliary Cholangitis (PBC). It is an open-label, long-term study designed for individuals who have previously participated in a related PBC study involving fenofibrate. Participants will be monitored for adverse effects and overall treatment response throughout the study duration.

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(NCT05751967)
3. 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: 862984771539

Similar studies

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

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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.