Fenofibrate in Patients With Primary Biliary Cholangitis (PBC)

NCT06365424 | Recruiting Phase 2

• 1 other identifier: KY20151230-5-1
• Study Type: interventional
• Target: 117
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Primary Biliary Cholangitis

Outcome Measures

Primary Outcomes (2)

• Treatment emergent adverse events (TEAEs)

  Through study completion, up to 120 Months

• Percentage of patients with biochemical response

  The normalisation of Alkaline Phosphatase

  Through study completion, up to 120 Months

Study Arms (2)

UDCA

ACTIVE COMPARATOR

Drug: UDCA

UDCA+Fenofibrate

EXPERIMENTAL

Drug: Fenofibrate; Drug: UDCA

Interventions

Fenofibrate DRUG

Fenofibrate (200 mg/day)

UDCA+Fenofibrate

UDCA DRUG

Ursodeoxycholic acid (13-15 mg/kg/day)

UDCA; UDCA+Fenofibrate

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Xijing Hospital of Digestive Diseases: lead

Study Sites (1)

Xijing Hospital

Xi'an, Shaanxi, China

RECRUITING

MeSH Terms

Conditions

Liver Cirrhosis, Biliary

Interventions

Fenofibrate

Condition Hierarchy (Ancestors)

Cholestasis, Intrahepatic; Cholestasis; Bile Duct Diseases; Biliary Tract Diseases; Digestive System Diseases; Liver Diseases; Liver Cirrhosis; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Fibric Acids; Isobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Phenyl Ethers; Ethers; Benzophenones; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Phenols; Ketones

Central Study Contacts

Yansheng Liu, MD

CONTACT

+862984771539; liuyansheng506@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 10, 2024
• First Posted: April 15, 2024
• Study Start: April 8, 2017
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): April 1, 2027
• Last Updated: July 2, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)