Loading clinical trials...

Fenofibrate for Compensated Cirrhosis Patients With Primary Biliary Cholangitis | Clinical Trials | Clareo Health

RECRUITINGPHASE2/PHASE3

Fenofibrate for Compensated Cirrhosis Patients With Primary Biliary Cholangitis

Fenofibrate Combined With Ursodeoxycholic Acid in Compensated Cirrhosis Patients With Primary Biliary Cholangitis Who Had an Inadequate Response to Ursodeoxycholic Acid

NCT05749822•Xijing Hospital of Digestive Diseases

View on ClinicalTrials.gov

Summary

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).

Detailed Description

This is a multi-center, randomized, placebo-controlled, parallel-group study that aims to assess the efficacy and safety of fenofibrate in patients with compensated cirrhosis PBC who had an inadequate biochemical response to UDCA. Fenofibrate or placebo 200 mg will be daily administered in combination with UDCA 13-15 mg/kg/d for 12 months.

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.
•Diagnosis of compensated cirrhosis, as demonstrated by the presence of ≥ 1 of the following 4 diagnostic factor
•1. The histology was consistent with the diagnosis of liver cirrhosi;
•2. Endoscopy shows esophageal and gastric varices or ectopic varices of digestive tract, excluding non cirrhotic portal hypertension;
+4 more criteria

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 (12)

Peking Union Medical College Hospital

Beijing, Beijing Municipality, China

Sun Yat-sen Memorial Hospital

Guangzhou, Guangdong, China

Henan Provincial People's Hospital

Zhengzhou, Henan, China

Xiangya Hospital Central South University

Changsha, Hunan, China

Jiangsu Province Hospital

Nanjing, Jiangsu, China

The First Hospital of China Medical University

Shenyang, Liaoning, China

Xijing Hospital

Xi'an, Shaanxi, China

Yan'an University Affiliated Hospital

Yan’an, Shaanxi, China

Sichuan Provincial People's Hospital

Chengdu, Sichuan, China

Tianjin Third Central Hospital

Tianjin, Tianjin Municipality, China

Key Dates

Start Date

February 17, 2023

Primary Completion Date

December 1, 2027

Completion Date

December 31, 2027

Last Updated

January 8, 2026

Enrollment

104

ESTIMATED participants

Conditions

Primary Biliary Cholangitis

Interventions

Fenofibrate 200mg

DRUG

Placebo

DRUG

UDCA

DRUG

Contacts

Yulong Shang

CONTACT

+86-29-84771539 shangyl870222@163.com

Ying Han

CONTACT

+86-29-84771539 hanying1@fmmu.edu.cn

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

View study

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: January 8, 2026Data 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.

View ClinicalTrials.gov Terms and Conditions

Fenofibrate for Compensated Cirrhosis Patients With 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

Fenofibrate Combined With Ursodeoxycholic Acid in Subjects With Primary Biliary Cholangitis

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

EMPower Mechanisms