Actively Recruiting
Fenofibrate for Compensated Cirrhosis Patients With Primary Biliary Cholangitis
Led by Xijing Hospital of Digestive Diseases · Updated on 2026-01-08
104
Participants Needed
12
Research Sites
254 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official 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 between 18 and 75 years
- Body mass index (BMI) between 17 and 28 kg/m2
- Diagnosis of primary biliary cholangitis confirmed by at least two of the following: history of alkaline phosphatase above upper limit of normal for at least six months, positive antimitochondrial antibodies or PBC-specific antinuclear antibodies, or liver biopsy consistent with PBC
- Diagnosis of compensated cirrhosis demonstrated by at least one of: histology showing cirrhosis, endoscopy showing esophageal or gastric varices, imaging showing liver cirrhosis or portal hypertension signs, or abnormal lab values indicating cirrhosis
- Incomplete biochemical response to ursodeoxycholic acid defined by alkaline phosphatase greater than 1.67 times upper limit of normal
- Taking ursodeoxycholic acid for at least six months with stable dose for at least three months prior to Day 0
You will not qualify if you...
- History or presence of other liver diseases
- ALT or AST levels greater than 5 times the upper limit of normal, total bilirubin greater than 3 times upper limit of normal
- Women who are pregnant, lactating, or have positive pregnancy tests
- Allergy to fenofibrate or ursodeoxycholic acid
- Use of hepatotoxic drugs for more than two weeks within six months or long-term hormone use
- History of recurrent variceal bleeding, poorly controlled hepatic encephalopathy, or refractory ascites
- Severe cardiac, cerebrovascular, renal, respiratory diseases, or psychiatric disorders including alcohol or drug abuse
- Creatinine above 1.5 times upper limit of normal or creatinine clearance below 60 ml/min
- Current use of statins, other fibrates, or drugs similar to fenofibrate
- Planned organ transplant or previous organ transplant recipient
- Expected need for liver transplantation within one year based on 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
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
CONTACT
Y
Ying Han
CONTACT
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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