Fenofibrate for primary biliary cholangitis

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

This open-label study tries fenofibrate long-term to see if it is safe and tolerable for people with primary biliary cholangitis who completed a prior fenofibrate PBC study.

Quick facts

• Phase: EARLY_PHASE1
• Study type: Interventional
• Enrollment: 15 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Xijing Hospital of Digestive Diseases (other)
• Locations: 1 site (Xi'an, Shaanxi)
• Trial ID: NCT07104201 on ClinicalTrials.gov

What this trial studies

This is an open-label, long-term early phase 1 safety and tolerability study of fenofibrate in people with primary biliary cholangitis (PBC). Enrollment is restricted to subjects who completed a prior fenofibrate PBC study (NCT06591455). Participants will take fenofibrate and be followed for adverse events and tolerability, with investigators monitoring for medical issues that could confound results. The single-site trial is conducted at Xijing Hospital of Digestive Diseases in Xi'an, Shaanxi, China.

Who should consider this trial

Good fit: Adults with PBC who completed the prior fenofibrate PBC study (NCT06591455), can give informed consent, and agree to required contraceptive measures if applicable are eligible.

Not a fit: Patients who previously stopped fenofibrate because of treatment-related adverse events or who have other medical conditions that would confound participation are unlikely to benefit from joining this study.

Why it matters

Potential benefit: If successful, this could confirm that fenofibrate is safe to use long-term in people with PBC and support broader use where appropriate.

How similar studies have performed: Previous smaller studies and clinical reports have suggested fenofibrate can improve liver biochemistry in PBC, but long-term safety data remain limited.

Eligibility criteria

Inclusion Criteria:

1. Must have given written informed consent (signed and dated)
2. Completed in a PBC study with fenofibrate(NCT06591455)
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)

Conditions: Primary Biliary Cholangitis