Fenofibrate Combined with Ursodeoxycholic Acid in Subjects with Primary Biliary Cholangitis

Launched by XIJING HOSPITAL OF DIGESTIVE DISEASES · Feb 20, 2023

Keywords

ClinConnect Summary

This clinical trial is studying the effectiveness of combining two medications, fenofibrate and ursodeoxycholic acid (UDCA), to treat patients with Primary Biliary Cholangitis (PBC). UDCA is commonly used as the first treatment for PBC, but some patients do not respond well to it. This study aims to find a way to identify those who might not benefit from UDCA alone sooner, so they can receive additional treatment options more quickly. Researchers have developed a new set of guidelines (called the Xi'an criteria) to help spot patients at higher risk of not responding to UDCA after just one month of treatment.

To participate in this trial, individuals need to be between 18 and 75 years old and have been diagnosed with PBC. They should not have responded well to UDCA based on the new criteria after a few weeks of treatment. Participants can expect to be monitored closely during the trial, and they will receive the combination treatment to see if it improves their condition. It’s important for potential participants to know that there are specific health conditions and medications that may exclude them from this study to ensure their safety.

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:
• • History of AP above ULN for at least six months;
• • Positive AMA titers (\>1/40 on immunofluorescence or M2 positive by enzyme linked immunosorbent assay (ELISA) or positive PBC-specific antinuclear antibodies;
• • Documented liver biopsy result consistent with PBC.
• • Incomplete response to UDCA defined by Xi'an criteria (ALP \>2.5× ULN, AST\>2×ULN or TBIL\>1×ULN) after UDCA treatment for 4-6 weeks with at least one abnormal test in ALP or TBIL.
• Exclusion Criteria:
• • History or presence of other concomitant liver diseases.
• • ALT/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 the quality of the clinical study, as judged by the Investigator.