Fenofibrate in Patients With Primary Biliary Cholangitis (PBC)

Phase 2

Recruiting

• Conditions: Primary Biliary Cholangitis
• Interventions: Drug: Fenofibrate; Drug: UDCA

• Registration Number: NCT06365424
• Lead Sponsor: Xijing Hospital of Digestive Diseases

Brief Summary

An Open Label Long-Term Study to Evaluate the Safety and Effectiveness of Fenofibrate in Subjects with Primary Biliary Cholangitis (PBC)

Detailed Description

Not available

Study Timeline

• Study Start: 2017-04-08
• Study First Submitted: 2024-04-10
• Study First Submitted QC: 2024-04-10
• Study First Posted: 2024-04-15
• Status Verified: 2025-06
• Last Update Submitted: 2025-07-01
• Last Update Posted: 2025-07-02
• Primary Completion: 2027-04
• Study Completion: 2027-04-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 117

Inclusion Criteria

• Must have given written informed consent (signed and dated)
• Participated in the PBC study with fenofibrate (NCT02823353)
• 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

• Treatment-related adverse event (AE) leading to fenofibrate discontinuation
• A medical condition, other than PBC, that in the investigator's opinion would preclude full participation in the study or confound its results (e.g., cancer)
• Known history of other liver diseases
• For females, pregnancy or breast-feeding
• Long-term use of immunosuppressive agents
• Any other condition(s) that would compromise the safety of the subject or compromise the quality of the clinical study, as judged by the Investigator

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
UDCA+Fenofibrate	Fenofibrate	-
UDCA+Fenofibrate	UDCA	-
UDCA	UDCA	-

Primary Outcome Measures

Name	Time	Method
Percentage of patients with biochemical response	Through study completion, up to 120 Months	The normalisation of Alkaline Phosphatase
Treatment emergent adverse events (TEAEs)	Through study completion, up to 120 Months

Trial Locations

Locations (1)

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