Fenofibrate in Combination With Ursodeoxycholic Acid in Primary Biliary Cholangitis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE2/PHASE3

Total Enrollment

184 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-08-21

Study Completion Date

2026-12-31

Brief Summary

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The main objectives of the study were to assess the effects of fenofibrate on serum alkaline phosphatase, as a composite endpoint and on safety in participants with primary biliary cholangitis (PBC)

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Detailed Description

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Conditions

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Primary Biliary Cholangitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Fenofibrate-ursodesoxycholic acid（UDCA）

Fenofibrate 200 mg/day and UDCA 13-15mg/kg/day for 12 months

Group Type EXPERIMENTAL

Fenofibrate

Intervention Type DRUG

Fenofibrate 200 mg/day

UDCA

Intervention Type DRUG

UDCA 13-15mg/kg/day

Placebo-UDCA

1 tablet/ day and UDCA 13-15mg/kg/day for 12 months

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

1 tablet/ day

UDCA

Intervention Type DRUG

UDCA 13-15mg/kg/day

Interventions

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Fenofibrate

Fenofibrate 200 mg/day

Intervention Type DRUG

Placebo

1 tablet/ day

Intervention Type DRUG

UDCA

UDCA 13-15mg/kg/day

Intervention Type DRUG

Eligibility Criteria

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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 alkaline phosphatase（ALP） above upper limit of normal（ULN） for at least six months;
2. Positive Anti-mitochondrial antibody (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.
* Incomplete response to UDCA defined by 1 x ULN\< ALP \<= 1.67 x ULN
* Taking UDCA for at least 6 months (stable dose for ≥ 3 months) prior to Day 0

Exclusion Criteria

* History or presence of other concomitant liver diseases.
* ALT or AST \> 5×ULN, total bilirubin（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