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Clinical Trials in China / NCT06755541
Recruiting Phase 3

Fenofibrate in Combination With Ursodeoxycholic Acid in Primary Biliary Cholangitis: a Real World Study

NCT06755541 · tracked via the Priya Life Science China tracker
Sponsor
Xijing Hospital of Digestive Diseases
Phase
Phase 3
Started
2024-01-30
Last updated
2026-01-08

Condition(s) studied

Primary Biliary Cholangitis (PBC)

Investigational drug(s) / intervention(s)

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)

Trial sites (1)

FacilityCityRegionStatus
Xijing hospital Xi'an Shaanxi Recruiting

More Xijing Hospital of Digestive Diseases trials in China

Other trials for the same condition

Official registry record

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.

View NCT06755541 on ClinicalTrials.gov ↗ ← All trials in China