A Pilot Study of Fenofibrate and Ursodeoxycholic Acid in the Treatment of Newly Diagnosed Primary Biliary Cholangitis

NCT ID: NCT06591455

Last Updated: 2025-11-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-09-14
• Study Completion Date: 2025-08-18

Brief Summary

This study is a prospective, single center, randomized controlled, exploratory clinical trial aimed at evaluating the efficacy and safety of fenofibrate in newly diagnosed PBC subjects.

Conditions

Primary Biliary Cholangitis (PBC)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

fenofibrate

fenofibrate 200mg/day

Group Type: EXPERIMENTAL

Fenofibrate

Intervention Type: DRUG

Fenofibrate 200mg/day

UDCA

UDCA 13-15mg/kg/day

Group Type: ACTIVE_COMPARATOR

UDCA (Ursodeoxycholic acid)

Intervention Type: DRUG

UDCA 13-15mg/kg/day

Interventions

Fenofibrate

Fenofibrate 200mg/day

Intervention Type: DRUG

UDCA (Ursodeoxycholic acid)

UDCA 13-15mg/kg/day

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Must have provided written informed consent
• Age 18-75 years;
• BMI 17-28 kg/m2
• Male or female with a diagnosis of PBC, by at least two of the following criteria:

1. History of AP above ULN for at least six months;

2. Positive AMA titers (>1/40 on immunofluorescence or M2 positive by enzyme linked immunosorbent assay (ELISA) or positive PBC-specific antinuclear antibodies;

3. Documented liver biopsy result consistent with PBC.

• Not receiving UDCA treatment before enrollment, ALP>ULN

Exclusion Criteria

• History or presence of other concomitant liver diseases.
• ALT or AST > 5×ULN, TBIL > 3×ULN.
• If female: known pregnancy, or has a positive urine pregnancy test (confirmed by a positive serum pregnancy test), or lactating.
• Allergic to fenofibrate or ursodeoxycholic acid.
• Taking hepatotoxic drugs (e.g., dapsone, erythromycin, fluconazole, ketoconazole, rifampicin) for more than 2 weeks within 6 months, and long-term hormonal users.
• Recurrent variceal bleeding, poorly controlled hepatic encephalopathy or refractory ascites.
• Patients with a history of severe cardiac, cerebrovascular, renal, respiratory disease or functional failure, and psychiatric disorders (including those due to alcohol and drug abuse).
• Creatinine >1.5×ULN and creatinine clearance <60 ml/min.
• Currently using statins (such as pravastatin, fluvastatin, and simvastatin), other fibrates (such as gemfibrozil and bezafibrate), and drugs structurally similar to fenofibrate (like ketoprofen).
• Planned to receive an organ transplant or an organ transplant recipient.
• Needing Liver transplantation within 1 year according to the Mayo Rick score.
• Any other condition(s) that would compromise the safety of the subject or compromise

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Han Ying

OTHER

Sponsor Role: lead

Responsible Party

Han Ying

Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Xijing hospital

Xi'an, Shaanxi, China

Countries

China

Other Identifiers

KY20242282

Identifier Type: -

Identifier Source: org_study_id