Actively Recruiting
Fenofibrate in Patients With Primary Biliary Cholangitis (PBC)
Led by Xijing Hospital of Digestive Diseases · Updated on 2025-07-02
117
Participants Needed
1
Research Sites
520 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
An Open Label Long-Term Study to Evaluate the Safety and Effectiveness of Fenofibrate in Subjects with Primary Biliary Cholangitis (PBC)
CONDITIONS
Official 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 (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
AI-Screening
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Trial Site Locations
Total: 1 location
1
Xijing Hospital
Xi'an, Shaanxi, China
Actively Recruiting
Research Team
Y
Yansheng Liu, MD
CONTACT
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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