Actively Recruiting
Fenofibrate Combined With Ursodeoxycholic Acid in Subjects With Primary Biliary Cholangitis
Led by Xijing Hospital of Digestive Diseases · Updated on 2026-01-08
150
Participants Needed
7
Research Sites
249 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Current treatment guidelines recommend ursodeoxycholic acid (UDCA) as the first-line treatment for new-diagnosed primary biliary cholangitis (PBC) patients. However, up to 40% patients are insensitive to UDCA monotherapy, and evaluation of UDCA response at 12 months may result in long period of ineffective treatment. We aimed to develop a new criterion to reliably identify non-response patients much earlier. Recently, our team designed and validated a new early criterion for distinguishing high-risk PBC patients in a Chinese population for the first time. Our data indicated that PBC patients with ALP ≤ 2.5 × ULN, AST ≤ 2 × ULN, and TBIL ≤ 1 × ULN (Xi'an criterion) after 1 month UDCA treatment were likely to have better prognosis. It can be readily applied in the rapid identification of PBC patients who require additional therapeutic approaches. However, whether it is reasonable to apply it to the response definition of clinical research, and the guidance of PBC management and choice of second-line treatment, further research is needed.
CONDITIONS
Official Title
Fenofibrate Combined With Ursodeoxycholic Acid in Subjects With Primary Biliary Cholangitis
Who Can Participate
Eligibility Criteria
You may qualify if you...
-
Must have provided written informed consent;
-
Age 18-75 years;
-
BMI 17-28 kg/m2
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Male or female with a diagnosis of PBC, by at least two of the following criteria:
- History of AP above ULN for at least six months;
- Positive AMA titers (>1/40 on immunofluorescence or M2 positive by enzyme linked immunosorbent assay (ELISA) or positive PBC-specific antinuclear antibodies;
- Documented liver biopsy result consistent with PBC.
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Incomplete response to UDCA defined by Xi'an criteria (ALP >2.5× ULN, AST>2×ULN or TBIL>1×ULN) after UDCA treatment for 4-6 weeks with at least one abnormal test in ALP or TBIL.
You will not qualify if you...
- History or presence of other concomitant liver diseases.
- ALT/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.
- Needing Liver transplantation within 1 year according to the Mayo Rick score.
- Any other condition(s) that would compromise the safety of the subject or compromise the quality of the clinical study, as judged by the Investigator.
AI-Screening
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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
CONTACT
Y
Ying Han
CONTACT
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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