Actively Recruiting
Fenofibrate Combined With Ursodeoxycholic Acid in Primary Biliary Cholangitis Patients Who Do Not Fully Respond to Ursodeoxycholic Acid: A Randomized, Double-blind, Placebo-controlled Multi-center Study
Led by Xijing Hospital of Digestive Diseases · Updated on 2026-01-08
150
Participants Needed
7
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating the use of fenofibrate combined with ursodeoxycholic acid (UDCA) in patients with primary biliary cholangitis (PBC) who do not respond adequately to UDCA alone. This study addresses the challenge that about 40% of PBC patients are insensitive to UDCA monotherapy, and current guidelines recommend UDCA as the first-line treatment. A new early criterion called the Xi'an criterion helps identify patients unlikely to respond well after just one month of UDCA treatment, aiming to improve management and treatment options. This is a multi-center, randomized, placebo-controlled, double-blind trial where participants will receive either fenofibrate 200 mg daily or a placebo, in combination with UDCA at 13-15 mg/kg daily, for 48 months. The study evaluates the efficacy and safety of fenofibrate added to UDCA in patients with incomplete biochemical response to UDCA based on the Xi'an criteria. Participants will be monitored regularly through biochemical tests, liver function markers, assessments of liver fibrosis, portal hypertension features, pruritus, and quality of life using validated scales. The primary outcome is the percentage of patients achieving complete normalization of alkaline phosphatase (ALP) and total bilirubin (TBIL) at 48 weeks. Secondary outcomes include adverse events, survival without liver transplantation or decompensation, and changes in liver function and quality of life over time.
CONDITIONS
Brief Title
Fenofibrate Combined With Ursodeoxycholic Acid in Subjects 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
- Male or female diagnosis of primary biliary cholangitis confirmed by at least two criteria: history of elevated alkaline phosphatase for at least six months, positive antimitochondrial antibodies or PBC-specific antinuclear antibodies, or liver biopsy consistent with PBC
- Incomplete response to ursodeoxycholic acid based on Xi'an criteria after 4-6 weeks of treatment with at least one abnormal alkaline phosphatase or total bilirubin test
You will not qualify if you...
- History or presence of other liver diseases
- Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) levels greater than 5 times upper limit of normal (ULN), or total bilirubin over 3 times ULN
- Known pregnancy, positive pregnancy test, or breastfeeding
- Allergy to fenofibrate or ursodeoxycholic acid
- Use of hepatotoxic drugs for more than 2 weeks within 6 months or long-term hormonal use
- Recurrent variceal bleeding, poorly controlled hepatic encephalopathy, or refractory ascites
- History of severe cardiac, cerebrovascular, renal, respiratory diseases, functional failure, or psychiatric disorders
- Creatinine levels over 1.5 times ULN or creatinine clearance below 60 ml/min
- Current use of statins, fibrates other than fenofibrate, or drugs similar to fenofibrate
- Planned or prior organ transplant
- Need for liver transplantation within 1 year according to Mayo Risk score
- Any condition that compromises safety or study quality as judged by the investigator
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 48 months
Participants take fenofibrate or placebo daily in combination with ursodeoxycholic acid for primary biliary cholangitis.
Regular visits for assessments at Weeks 4, 12, 24, 36, and 48
Duration - Up to 48 weeks after treatment start
Participants are monitored for safety, liver function, quality of life, and survival without liver transplantation or decompensation.
Follow-up visits aligned with treatment assessment schedule
Trial Site Locations
Total: 7 locations
1
The second hospital of Lanzhou University
Lanzhou, Gansu, China
Actively Recruiting
2
Sun Yat-sen Memorial Hospital
Guangzhou, Guangdong, China
Not Yet Recruiting
3
Nanjing Drum Tower Hospital
Nanjing, Jiangsu, China
Actively Recruiting
4
The First Hospital of China Medical University
Shenyang, Liaoning, China
Actively Recruiting
5
Ying han
Xi'an, Shaanxi, China, 710032
Actively Recruiting
6
Sichuan Provincial People's Hospital,
Chengdu, Sichuan, China
Actively Recruiting
7
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
PREVENTION
Number of Arms
2
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