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 whether combining fenofibrate with ursodeoxycholic acid is safe and helpful for people with Primary Biliary Cholangitis who have taken part in a related study before.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 150 (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 | NCT06755541 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include individuals 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 combination therapy could improve treatment outcomes for patients with Primary Biliary Cholangitis.
How similar studies have performed: While this approach is being evaluated in this specific context, similar studies have shown promise in exploring combination therapies for PBC.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Xi'an, Shaanxi
- Xijing hospital — Xi'an, Shaanxi, China (Recruiting)
Study contacts
- Study coordinator: Yansheng Liu
- Email: liuyansheng506@163.com
- Phone: 862984771539
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.