Fenofibrate for Compensated Cirrhosis Patients with Primary Biliary Cholangitis

Launched by XIJING HOSPITAL OF DIGESTIVE DISEASES · Feb 28, 2023

Keywords

ClinConnect Summary

This clinical trial is studying the effects of a medication called fenofibrate on patients with a liver condition known as Primary Biliary Cholangitis (PBC) who also have compensated cirrhosis. The main goal is to see how fenofibrate affects liver enzyme levels in the blood, specifically a substance called alkaline phosphatase, while also checking for any potential side effects. The trial is currently looking for participants aged 18 to 75 who have a confirmed diagnosis of PBC and have been taking a standard treatment called UDCA for at least six months without sufficient improvement.

Eligible participants should not have other serious liver diseases, severe health issues affecting the heart or kidneys, or be taking specific medications that could interfere with the study. Those who join the trial can expect to receive the study medication and will be closely monitored for its effects on their liver health. It's important to know that this is a Phase 2 trial, meaning it's an early-stage study aimed at understanding the effectiveness and safety of fenofibrate for this particular group of patients.

Gender

ALL

Eligibility 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