Actively Recruiting
Fenofibrate in Primary Biliary Cholangitis: a Real World Study
Led by Xijing Hospital of Digestive Diseases · Updated on 2026-01-08
300
Participants Needed
1
Research Sites
619 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 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) 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 according to the Investigator's opinion
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
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here