Using Fenofibrate with Ursodeoxycholic Acid for Primary Biliary Cholangitis

An Open Label Long-Term Study to Evaluate the Safety and Tolerability of Fenofibrate in Combination With Ursodeoxycholic Acid in Subjects With Primary Biliary Cholangitis (PBC)

This study is testing if taking fenofibrate with ursodeoxycholic acid can be safe and helpful for people with Primary Biliary Cholangitis who have already been part of a related study.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 300 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Xijing Hospital of Digestive Diseases (Academic / other)
• Locations: 1 site (Xi'an, Shaanxi)
• Trial ID: NCT06755151 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are individuals diagnosed with Primary Biliary Cholangitis who have previously participated in a fenofibrate study.

Not a fit: Patients with treatment-related adverse events from previous studies or other confounding medical conditions may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could improve the management and outcomes for patients with Primary Biliary Cholangitis.

How similar studies have performed: Other studies involving fenofibrate for PBC have shown promise, indicating potential for success in this approach.

Eligibility criteria

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 this trial is running

Xi'an, Shaanxi

• Xijing hospital — Xi'an, Shaanxi, China (Recruiting)

Study contacts

• Study coordinator: Yansheng Liu

Conditions Primary Biliary Cholangitis