Actively Recruiting
An Open Label Long-Term Study to Evaluate the Safety and Effectiveness of Fenofibrate in Subjects With Primary Biliary Cholangitis (PBC)
Led by Xijing Hospital of Digestive Diseases · Updated on 2025-07-02
117
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to evaluate the long-term safety and effectiveness of fenofibrate in adults with Primary Biliary Cholangitis (PBC). The trial is open-label and includes participants who have previously taken part in a related fenofibrate study for PBC. The study is sponsored by Xijing Hospital of Digestive Diseases and involves patients aged 18 to 75 years. Participants are randomly assigned to receive either ursodeoxycholic acid (UDCA) alone or UDCA combined with fenofibrate (200 mg/day). UDCA is given at a dose of 13-15 mg/kg/day. The study monitors patients over a long period, up to 120 months, to observe treatment effects and safety. Throughout the study, researchers track treatment emergent adverse events and biochemical responses to the treatments. Participants provide written consent and must follow contraceptive measures if of reproductive potential. The study involves regular monitoring to assess safety and treatment response, with full participation expected over the study duration ending in April 2027.
CONDITIONS
Brief Title
Fenofibrate in Patients With Primary Biliary Cholangitis (PBC)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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
You will not qualify if you...
- Treatment-related adverse event leading to fenofibrate discontinuation
- A medical condition other than PBC that would preclude full participation or confound results (e.g., cancer)
- Known history of other liver diseases
- Pregnancy or breast-feeding for females
- Long-term use of immunosuppressive agents
- Any other condition compromising safety or study quality 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.
Duration - Up to 120 months
Participants receive Fenofibrate and/or Ursodeoxycholic acid (UDCA) as part of the study treatment.
Trial Site Locations
Total: 1 location
1
Xijing Hospital
Xi'an, Shaanxi, China
Actively Recruiting
Research Team
Y
Yansheng Liu, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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