Actively Recruiting
Fenofibrate in Combination With Ursodeoxycholic Acid in Primary Biliary Cholangitis: a Real World Study
Led by Xijing Hospital of Digestive Diseases · Updated on 2026-01-08
150
Participants Needed
1
Research Sites
617 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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)
CONDITIONS
Official 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 in 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 study drug discontinuation in a previous PBC study with seladelpar
- A medical condition, other than PBC, that in the Investigator's opinion would preclude full participation in the study or confound its results
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Xijing hospital
Xi'an, Shaanxi, China
Actively Recruiting
Research Team
Y
Yansheng Liu
CONTACT
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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