Fenofibrate Combined With Ursodeoxycholic Acid in Subjects With Primary Biliary Cholangitis
NCT ID: NCT05751967
Last Updated: 2026-01-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
150 participants
INTERVENTIONAL
2023-02-22
2027-12-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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Placebo
1 tablet/ day
Placebo Combined With Ursodeoxycholic Acid
1 tablet/ day
Fenofibrate
200 mg/day
Fenofibrate Combined With Ursodeoxycholic Acid
200 mg/day
Interventions
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Placebo Combined With Ursodeoxycholic Acid
1 tablet/ day
Fenofibrate Combined With Ursodeoxycholic Acid
200 mg/day
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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:
* 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.
* 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.
Exclusion Criteria
* 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.
18 Years
75 Years
ALL
No
Sponsors
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Xijing Hospital of Digestive Diseases
OTHER
Responsible Party
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Han Ying
Professor
Principal Investigators
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Ying Han, Doctor
Role: PRINCIPAL_INVESTIGATOR
The First Affiliated Hospital of Air Force Medicial University
Locations
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The second hospital of Lanzhou University
Lanzhou, Gansu, China
Sun Yat-sen Memorial Hospital
Guangzhou, Guangdong, China
Nanjing Drum Tower Hospital
Nanjing, Jiangsu, China
The First Hospital of China Medical University
Shenyang, Liaoning, China
Ying han
Xi'an, Shaanxi, China
Sichuan Provincial People's Hospital,
Chengdu, Sichuan, China
Tianjin Medical University General Hospital
Tianjin, , China
Countries
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Central Contacts
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Facility Contacts
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Role: primary
Other Identifiers
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KY20222274-C-1
Identifier Type: -
Identifier Source: org_study_id
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