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

Phase 3

Recruiting

• Conditions: Primary Biliary Cholangitis (PBC)
• Interventions: Drug: Fenofibrate in Combination With Ursodeoxycholic Acid

• Registration Number: NCT06755541
• Lead Sponsor: Xijing Hospital of Digestive Diseases

Brief 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)

Detailed Description

Not available

Study Timeline

• Study Start: 2024-01-30
• Status Verified: 2024-12
• Study First Submitted: 2024-12-24
• Study First Submitted QC: 2024-12-31
• Last Update Submitted: 2024-12-31
• Study First Posted: 2025-01-01
• Last Update Posted: 2025-01-01
• Primary Completion: 2035-12
• Study Completion: 2035-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 150

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
fenofibrate	Fenofibrate in Combination With Ursodeoxycholic Acid	Experimental: Fenofibrate 200 mg Capsules

Primary Outcome Measures

Name	Time	Method
Treatment emergent adverse events (TEAEs)	Through study completion, up to 120 Months

Secondary Outcome Measures

Name	Time	Method
Death	120 months	Occurrence of overall death
Liver transplantation	120 months	Occurrence of overall liver transplantation
Normalization of ALP	120 months	Proportion of subjects with normalization of ALP

Trial Locations

Locations (1)

Xijing hospital; 🇨🇳 Xi'an, Shaanxi, China