Fenofibrate for Compensated Cirrhosis Patients With Primary Biliary Cholangitis

• Status: Recruiting
• Trial end date: 2025-12-31
• Target enrollment: 0
• Participant gender: All

Summary

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).

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Xijing Hospital of Digestive Diseases
• Treatments: Fenofibrate

Criteria

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