Using Fenofibrate to treat Primary Biliary Cholangitis

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

This study tests if Fenofibrate can safely help people with Primary Biliary Cholangitis manage their liver condition over a long time.

Quick facts

• Phase: PHASE2; PHASE3
• Study type: Interventional
• Enrollment: 117 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Xijing Hospital of Digestive Diseases (other)
• Locations: 1 site (Xi'an, Shaanxi)
• Trial ID: NCT06365424 on ClinicalTrials.gov

What this trial studies

This study evaluates the safety and effectiveness of Fenofibrate in patients diagnosed with Primary Biliary Cholangitis (PBC). It is an open-label, long-term interventional study that includes participants who have previously taken part in another PBC study involving Fenofibrate. The study aims to gather data on how well Fenofibrate works in managing this liver condition over an extended period.

Who should consider this trial

Good fit: Ideal candidates for this study are individuals who have previously participated in a PBC study involving Fenofibrate and meet the inclusion criteria.

Not a fit: Patients with other liver diseases or those who have experienced adverse events leading to discontinuation of Fenofibrate will not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could improve liver function and quality of life for patients with Primary Biliary Cholangitis.

How similar studies have performed: Other studies have shown promise in using Fenofibrate for liver conditions, suggesting potential for success in this approach.

Eligibility criteria

Inclusion Criteria:

* Must have given written informed consent (signed and dated)
* Participated in the PBC study with fenofibrate (NCT02823353)
* 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:

* Treatment-related adverse event (AE) leading to fenofibrate discontinuation
* A medical condition, other than PBC, that in the investigator's opinion would preclude full participation in the study or confound its results (e.g., cancer)
* Known history of other liver diseases
* For females, pregnancy or breast-feeding
* Long-term use of immunosuppressive agents
* Any other condition(s) that would compromise the safety of the subject or compromise the quality of the clinical study, as judged by the Investigator

Where this trial is running

Xi'an, Shaanxi

• Xijing Hospital — Xi'an, Shaanxi, China (RECRUITING)

Study contacts

• Study coordinator: Yansheng Liu, MD

Conditions: Primary Biliary Cholangitis