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

NCT06755541 | Recruiting Phase 3

• 1 other identifier: KY20222274-C-1-1
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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)

Conditions

Primary Biliary Cholangitis (PBC)

Outcome Measures

Primary Outcomes (1)

• Treatment emergent adverse events (TEAEs)

  Through study completion, up to 120 Months

Secondary Outcomes (3)

• Death

  120 months

• Liver transplantation

  120 months

• Normalization of ALP

  120 months

Study Arms (1)

fenofibrate

EXPERIMENTAL

Experimental: Fenofibrate 200 mg Capsules

Drug: Fenofibrate in Combination With Ursodeoxycholic Acid

Interventions

Fenofibrate in Combination With Ursodeoxycholic Acid DRUG

Experimental: Fenofibrate 200 mg Capsules

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)
• Completed in a PBC study with fenofibrate(NCT05751967)
• 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

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; Ursodeoxycholic Acid

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; Deoxycholic Acid; Cholic Acids; Bile Acids and Salts; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Cholanes

Central Study Contacts

Yansheng Liu

CONTACT

862984771539; liuyansheng506@163.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 24, 2024
• First Posted: January 1, 2025
• Study Start: January 30, 2024
• Primary Completion (Estimated): December 1, 2035
• Study Completion (Estimated): December 1, 2035
• Last Updated: January 8, 2026

Record last verified: 2026-01

Locations

CN (1)