Fenofibrate in Combination With Ursodeoxycholic Acid in Primary Biliary Cholangitis

Launched by HAN YING · Dec 8, 2023

Keywords

ClinConnect Summary

This clinical trial is studying whether a medication called fenofibrate, when taken together with ursodeoxycholic acid (UDCA), can help lower levels of a substance called alkaline phosphatase in people with a liver condition known as primary biliary cholangitis (PBC). High levels of alkaline phosphatase can indicate liver problems, and the study aims to see if this combination of medications is safe and effective for patients who haven't fully responded to UDCA alone.

To participate in the trial, you need to be between 18 and 75 years old, have a confirmed diagnosis of PBC, and have been taking UDCA for at least six months. The trial is open to anyone who meets these criteria, but certain conditions or medications may exclude you from taking part. If you join the study, you'll be monitored closely to ensure your safety, and you'll receive information about your health throughout the process. This trial aims to find better treatments for PBC, so your involvement could help improve care for others with this condition in the future.

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 alkaline phosphatase（ALP） above upper limit of normal（ULN） for at least six months;
• • 2. Positive Anti-mitochondrial antibody (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.
• • Incomplete response to UDCA defined by 1 x ULN\< 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, total bilirubin（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