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A Pilot Study of Fenofibrate and Ursodeoxycholic Acid in the Treatment of Newly Diagnosed Primary Biliary Cholangitis | Clinical Trials | Clareo Health

COMPLETEDEARLY_PHASE1

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

A Single Center, Randomized Controlled, Pilot Study of Fenofibrate and Ursodeoxycholic Acid in the Treatment of Newly Diagnosed Primary Biliary Cholangitis

NCT06591455•Han Ying

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

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.
+2 more criteria

Locations (1)

Xijing hospital

Xi'an, Shaanxi, China

Key Dates

Start Date

September 14, 2024

Primary Completion Date

August 18, 2025

Completion Date

August 18, 2025

Last Updated

November 28, 2025

Enrollment

ACTUAL participants

Conditions

Primary Biliary Cholangitis (PBC)

Interventions

Fenofibrate

DRUG

UDCA (Ursodeoxycholic acid)

DRUG

A Two-part Study to Investigate the Effects in Adults of Two Doses of Golexanolone in Patients With Primary Biliary Cholangitis (PBC) With Fatigue and Cognitive Dysfunction

NCT07304843

Primary Biliary Cholangitis (PBC)

View study

RECRUITING

Biochemical Response and Clinical Outcomes in Patients With PBC

NCT07449793

Primary Biliary Cholangitis (PBC)Primary Biliary Cholangitis

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 28, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

A Two-part Study to Investigate the Effects in Adults of Two Doses of Golexanolone in Patients With Primary Biliary Cholangitis (PBC) With Fatigue and Cognitive Dysfunction

Biochemical Response and Clinical Outcomes in Patients With PBC

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

FIREFLY Trial: Fenofibrate Intervention---Randomized Evaluation in First-Line PBC Therapy

EMPower Mechanisms

A Multicenter, Randomized, Controlled Trial of Prednisone Combined With Ursodeoxycholic Acid in the Treatment of Primary Biliary Cholangitis With Moderate to Severe Interface Hepatitis Characteristics