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
150
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
This trial evaluates the safety and tolerability of fenofibrate combined with ursodeoxycholic acid in adults with Primary Biliary Cholangitis (PBC). It is a long-term, open-label Phase 3 study sponsored by Xijing Hospital of Digestive Diseases, focusing on patients continuing after a previous PBC fenofibrate study. The goal is to observe treatment effects and adverse events over an extended period. Participants receive fenofibrate as 200 mg capsules alongside ursodeoxycholic acid. The study does not include a placebo group and involves ongoing treatment with this combination. The trial spans up to 120 months, allowing researchers to track long-term safety and liver-related outcomes. Throughout the study, participants will be monitored for treatment-emergent adverse events, death, liver transplantation, and normalization of alkaline phosphatase (ALP) levels. Researchers will collect data continuously until study completion, with regular assessments to evaluate the safety and effectiveness of the treatment combination over time.
CONDITIONS
Brief Title
Fenofibrate in Combination With Ursodeoxycholic Acid 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 a PBC study with fenofibrate (NCT05751967)
- 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 discontinuation of study drug in a previous PBC study with seladelpar
- Any medical condition other than PBC that would prevent full participation or affect study results according to the Investigator's opinion
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.
Duration - Up to 120 months
Participants receive fenofibrate in combination with ursodeoxycholic acid to evaluate safety and tolerability.
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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