Fenofibrate in Subjects With Primary Biliary Cholangitis (PBC)

NCT07104201 | Active Not Recruiting Early Phase 1

• 1 other identifier: KY20252048-C-2
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

An Open Label Long-Term Study to Evaluate the Safety and Tolerability of Fenofibrate 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 (5)

• Normalization of ALP

  From enrollment to the end of treatment at 120 months

• The changes of liver function indicators

  From enrollment to the end of treatment at 120 months

• The percentage of patients achieving biochemical response criteria

  From enrollment to the end of treatment at 120 months

• Death

  From enrollment to the end of treatment at 120 months

• Liver transplantation

  From enrollment to the end of treatment at 120 months

Study Arms (1)

Fenofibrate

EXPERIMENTAL

Fenofibrate 200mg

Drug: Fenofibrate

Interventions

Fenofibrate DRUG

Fenofibrate 200mg

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 provided written informed consent
• Age 18-75 years;
• BMI 17-28 kg/m2
• Completed in a PBC study with fenofibrate(NCT06591455)

You may not qualify if:

• Coexisting liver disease of other etiologies, including viral hepatitis, chronic alcoholic hepatitis, drug-induced hepatitis, autoimmune hepatitis, hepatocellular carcinoma, etc.;
• Transaminases \>5 x ULN or total bilirubin \>3 x ULN;
• Pregnant or breastfeeding women, or women planning to conceive during the study period;
• Allergy to fenofibrate or ursodeoxycholic acid;
• Use of hepatotoxic drugs (e.g., dapsone, erythromycin, fluconazole, ketoconazole, rifampicin) for more than 2 weeks within 6 months before screening, or long-term corticosteroid use;
• Variceal bleeding, hepatic encephalopathy, or ascites at diagnosis or previously;
• History of severe cardiac, cerebrovascular, renal, or respiratory disease or failure, or psychiatric illness (including psychiatric illness caused by alcohol or drug abuse);
• Creatinine \>1.5 x ULN and creatinine clearance \<60 mL/min;
• Current use of statins (e.g., pravastatin, fluvastatin, simvastatin), other fibrates (e.g., gemfibrozil, bezafibrate), or structurally related drugs (e.g., ketoprofen);
• Planned organ transplantation or previous organ transplantation;
• Need for liver transplantation within 1 year according to the Mayo risk score;
• Any other condition considered unsuitable for enrollment by the investigator.

Sponsors & Collaborators

• Xijing Hospital of Digestive Diseases: lead

Study Sites (1)

Xijing Hospital

Xi'an, Shaanxi, 710032, China

Location

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

Study Design

• Study Type: interventional
• Phase: early phase 1
• 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: March 24, 2025
• First Posted: August 5, 2025
• Study Start: March 13, 2025
• Primary Completion (Estimated): March 1, 2035
• Study Completion (Estimated): March 1, 2035
• Last Updated: July 29, 2026

Record last verified: 2026-07

Locations

CN (1)