Actively Recruiting
Fenofibrate Combined With Ursodeoxycholic Acid in Compensated Cirrhosis Patients With Primary Biliary Cholangitis Who Had an Inadequate Response to Ursodeoxycholic Acid
Led by Xijing Hospital of Digestive Diseases · Updated on 2026-01-08
104
Participants Needed
12
Research Sites
4 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effects and safety of fenofibrate in patients with compensated cirrhosis due to primary biliary cholangitis (PBC) who have not responded adequately to ursodeoxycholic acid (UDCA). This multi-center, randomized, placebo-controlled study aims to assess whether adding fenofibrate to UDCA improves biochemical markers over 12 months. The study is conducted by Xijing Hospital of Digestive Diseases and includes participants aged 18 to 75 years with confirmed PBC and compensated cirrhosis. Participants will be randomly assigned to receive either fenofibrate 200 mg daily or a placebo, both combined with UDCA at 13-15 mg/kg per day for 12 months. This quadruple-masked trial compares these two groups in parallel to evaluate fenofibrate's biochemical response and safety profile. The treatment period lasts for one year with daily medication intake. Throughout the study, participants will have regular assessments including blood tests to measure biochemical response at multiple time points up to 48 weeks. Researchers will also monitor symptoms like itching and fatigue, track any biological or clinical adverse events, and evaluate survival without liver transplantation or hepatic impairment. Safety and treatment effects will be closely observed across the full duration of the trial.
CONDITIONS
Brief Title
Fenofibrate for Compensated Cirrhosis Patients With Primary Biliary Cholangitis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Provided written informed consent
- Age 18 to 75 years
- Body Mass Index (BMI) between 17 and 28 kg/m2
- Male or female with a diagnosis of primary biliary cholangitis confirmed by at least two of: history of alkaline phosphatase above upper limit normal for 6 months, positive antimitochondrial antibodies or PBC-specific antinuclear antibodies, or liver biopsy consistent with PBC
- Diagnosis of compensated cirrhosis shown by at least one of: liver histology confirming cirrhosis, endoscopy showing esophageal/gastric varices, imaging indicating cirrhosis or portal hypertension, or abnormal lab tests including low platelets, low serum albumin, prolonged clotting times, or elevated APRI score
- Incomplete response to ursodeoxycholic acid defined by alkaline phosphatase > 1.67 times upper limit normal
- Taking ursodeoxycholic acid for at least 6 months with a stable dose for 3 months prior to Day 0
You will not qualify if you...
- History or presence of other liver diseases besides PBC
- Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) over 5 times upper limit normal, total bilirubin over 3 times upper limit normal
- Pregnant or breastfeeding women
- Allergy to fenofibrate or ursodeoxycholic acid
- Use of hepatotoxic drugs for more than 2 weeks within 6 months or long-term hormone use
- Recurrent variceal bleeding, poorly controlled hepatic encephalopathy, or refractory ascites
- Severe cardiac, cerebrovascular, renal, respiratory disease or psychiatric disorders including substance abuse
- Creatinine over 1.5 times normal or creatinine clearance below 60 ml/min
- Current use of statins, other fibrates, or drugs similar to fenofibrate
- Planned organ transplant or transplant recipient
- Needing liver transplantation within 1 year according to Mayo Risk score
- Any other condition that could compromise participant safety or study integrity
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 12 months
Participants receive fenofibrate or placebo daily in combination with ursodeoxycholic acid for 12 months.
Visits at approximately 4, 12, 24, 36, and 48 weeks during treatment
Trial Site Locations
Total: 12 locations
1
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China
Actively Recruiting
2
Sun Yat-sen Memorial Hospital
Guangzhou, Guangdong, China
Not Yet Recruiting
3
Henan Provincial People's Hospital
Zhengzhou, Henan, China
Actively Recruiting
4
Xiangya Hospital Central South University
Changsha, Hunan, China
Actively Recruiting
5
Jiangsu Province Hospital
Nanjing, Jiangsu, China
Actively Recruiting
6
The First Hospital of China Medical University
Shenyang, Liaoning, China
Actively Recruiting
7
Xijing Hospital
Xi'an, Shaanxi, China
Actively Recruiting
8
Yan'an University Affiliated Hospital
Yan’an, Shaanxi, China
Actively Recruiting
9
Sichuan Provincial People's Hospital
Chengdu, Sichuan, China
Actively Recruiting
10
Tianjin Third Central Hospital
Tianjin, Tianjin Municipality, China
Actively Recruiting
11
The Second Affiliated Hospital of Kunming Medical University
Kunming, Yunnan, China
Actively Recruiting
12
Tianjin Medical University General Hospital
Tianjin, China
Actively Recruiting
Research Team
Y
Yulong Shang
Y
Ying Han
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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