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Fenofibrate for Compensated Cirrhosis Patients With Primary Biliary Cholangitis

RecruitingPhase 2, Phase 3Ages 18 Years - 75 YearsAllXijing Hospital of Digestive Diseases
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In plain words

What the trial is, and whether it could suit you

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).

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
Inclusion Criteria: * Must have provided written informed consent * 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: * History or presence of other concomitant liver diseases. * 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
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What it tests

  • Fenofibrate 200mg
  • Placebo
  • UDCA
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Where

12 sites
Peking Union Medical College Hospital
Beijing, China
Sun Yat-sen Memorial Hospital
Guangzhou, China
Henan Provincial People's Hospital
Zhengzhou, China
Xiangya Hospital Central South University
Changsha, China
Jiangsu Province Hospital
Nanjing, China
The First Hospital of China Medical University
Shenyang, China
Xijing Hospital
Xi'an, China
Yan'an University Affiliated Hospital
Yan’an, China

…and 4 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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