Actively Recruiting
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)
Led by Xijing Hospital of Digestive Diseases · Updated on 2026-01-08
300
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying the safety and tolerability of fenofibrate combined with ursodeoxycholic acid in people with Primary Biliary Cholangitis (PBC), a liver condition. This long-term, open-label study is designed to assess how well participants tolerate this combination treatment and monitor any side effects over time. Participants will receive fenofibrate at a dose of 200 mg along with ursodeoxycholic acid. The study does not use a placebo or blinding, and all participants know the treatment they are receiving. It is a phase 3 trial conducted over a period of up to 120 months (10 years), allowing researchers to observe long-term effects and outcomes. During the study, participants will be closely monitored for treatment-related side effects and adverse events. Researchers will track serious outcomes such as death, liver transplantation, and the normalization of alkaline phosphatase (ALP) levels. Participants will undergo regular assessments throughout the trial to ensure safety and gather detailed information on the treatment's impact over time.
CONDITIONS
Brief Title
Fenofibrate in Primary Biliary Cholangitis: a Real World Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Must have given written informed consent (signed and dated)
- Completed in a PBC study with fenofibrate (NCT05749822, NCT06174402)
- Alkaline phosphatase (ALP) level greater than 1 times the upper limit of normal (ULN)
- 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
You will not qualify if you...
- Treatment-related adverse event leading to study drug discontinuation in a previous PBC study with seladelpar
- Any medical condition other than PBC that would prevent full participation in the study or affect its results, as judged by the Investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 120 months
Participants receive Fenofibrate 200mg in combination with Ursodeoxycholic Acid to evaluate safety and tolerability.
Visits as scheduled throughout treatment duration
Trial Site Locations
Total: 1 location
1
Xijing hospital
Xi'an, Shaanxi, China
Actively Recruiting
Research Team
Y
Yansheng Liu
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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