Fenofibrate in Primary Biliary Cholangitis: a Real World Study

Recruiting now · Phase 3

Conditions studied: Primary Biliary Cholangitis (PBC)

In brief

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)

Key facts

Study ID

NCT06755151

Run by

Xijing Hospital of Digestive Diseases

People needed

300

Starts

2024-01-17

Expected to finish

2035-12-01

Last updated by the study team

2026-01-08

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Xijing hospital — Xi'an, Shaanxi, China (enrolling)

Full record on ClinicalTrials.gov

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