RecruitingPhase 3NCT06755151

Fenofibrate in Primary Biliary Cholangitis: a Real World Study

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)

Sponsor

Xijing Hospital of Digestive Diseases

Enrollment

300 participants

Start Date

Jan 17, 2024

Study Type

INTERVENTIONAL

Conditions

Primary Biliary Cholangitis (PBC)

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

Min Age: 18 YearsMax Age: 75 Years

Inclusion Criteria4

Must have given written informed consent (signed and dated)
Completed in a PBC study with fenofibrate(NCT05749822,NCT06174402)
ALP\> 1\*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

Exclusion Criteria2

Treatment-related adverse event (AE) 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

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