Fenofibrate in Combination With Ursodeoxycholic Acid
Fenofibrate in Combination With Ursodeoxycholic Acid: Experimental: Fenofibrate 200 mg Capsules
Study summary
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)
Eligibility
Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
Inclusion Criteria:
1. Must have given written informed consent (signed and dated)
2. Completed in a PBC study with fenofibrate(NCT05751967)
3. 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
Exclusion Criteria:
1. Treatment-related adverse event (AE) leading to study drug discontinuation in a previous PBC study with seladelpar
2. A medical condition, other than PBC, that in the Investigator's opinion would preclude full participation in the study or confound its results
Primary outcome measure(s)
Treatment emergent adverse events (TEAEs) — Through study completion, up to 120 Months
Trial sites (1)
Facility
City
Region
Status
Xijing hospital
Xi'an
Shaanxi
Recruiting
More Xijing Hospital of Digestive Diseases trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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