Fenofibrate for Compensated Cirrhosis Patients With Primary Biliary Cholangitis
NCT ID: NCT05749822
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
PHASE2/PHASE3
104 participants
INTERVENTIONAL
2023-02-17
2027-12-31
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
TREATMENT
QUADRUPLE
Study Groups
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Placebo-UDCA
1 tablet/ day and UDCA 13-15mg/kg/day for 12 months
UDCA
UDCA 13-15mg/kg/day
Placebo
1 tablet/ day
Fenofibrate-UDCA
Fenofibrate 200 mg/day and UDCA 13-15mg/kg/day for 12 months
UDCA
UDCA 13-15mg/kg/day
Fenofibrate 200mg
Fenofibrate 200mg/day
Interventions
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UDCA
UDCA 13-15mg/kg/day
Fenofibrate 200mg
Fenofibrate 200mg/day
Placebo
1 tablet/ day
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:
1. History of AP above ULN for at least six months;
2. Positive AMA titers (\>1/40 on immunofluorescence or M2 positive by enzyme linked immunosorbent assay (ELISA) or positive PBC-specific antinuclear antibodies;
3. Documented liver biopsy result consistent with PBC.
* Diagnosis of compensated cirrhosis, as demonstrated by the presence of ≥ 1 of the following 4 diagnostic factor
1. The histology was consistent with the diagnosis of liver cirrhosi;
2. Endoscopy shows esophageal and gastric varices or ectopic varices of digestive tract, excluding non cirrhotic portal hypertension;
3. Ultrasound or CT and other imaging examinations indicate the characteristics of liver cirrhosis or portal hypertension, such as splenomegaly, portal vein ≥ 1.3 cm, or liver stiffness measured by transient elastography\>16.9 kPa;
4. Abnormal laboratory inspection indicators (2 out of 4): 1) PLT \< 100 × 109/L, and no other reason can be explained; 2) Serum albumin\<35 g/L, excluding malnutrition or kidney disease and other causes; 3) INR \> 1.3 or PT prolongation (stop thrombolytic or anticoagulant drugs for more than 7 days); 4) AST/PLT (APRI)\>2）
* Incomplete response to UDCA defined by ALP \> 1.67 x ULN
* Taking UDCA for at least 6 months (stable dose for ≥ 3 months) prior to Day 0
Exclusion Criteria
* ALT or 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
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
Role: PRINCIPAL_INVESTIGATOR
Xijing Hospital, Air Force Military Medical Universit
Locations
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Peking Union Medical College Hospital
Beijing, Beijing Municipality, China
Sun Yat-sen Memorial Hospital
Guangzhou, Guangdong, China
Henan Provincial People's Hospital
Zhengzhou, Henan, China
Xiangya Hospital Central South University
Changsha, Hunan, China
Jiangsu Province Hospital
Nanjing, Jiangsu, China
The First Hospital of China Medical University
Shenyang, Liaoning, China
Xijing Hospital
Xi'an, Shaanxi, China
Yan'an University Affiliated Hospital
Yan’an, Shaanxi, China
Sichuan Provincial People's Hospital
Chengdu, Sichuan, China
Tianjin Third Central Hospital
Tianjin, Tianjin Municipality, China
The Second Affiliated Hospital of Kunming Medical University
Kunming, Yunnan, 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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Li
Role: primary
Ying Han
Role: primary
Other Identifiers
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KY20222293-C-1
Identifier Type: -
Identifier Source: org_study_id
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