Study of Lowering Ursodeoxycholic Acid Dosage in Adults With Primary Biliary Cholangitis Who Have Fully Responded to Treatment

What this Trial Is About

Primary biliary cholangitis PBC is a chronic autoimmune liver disease that causes progressive bile duct damage leading to liver fibrosis and cirrhosis if untreated. This research aims to explore whether lowering the dosage of ursodeoxycholic acid UDCA, the main treatment for PBC in China, is feasible for patients with a complete response to standard treatment. The study involves patients who have shown improved liver function after UDCA treatment and seeks to understand the effects of reduced dosing on disease recurrence and patient health. Participants will be randomly assigned to one of three groups two experimental groups receiving reduced UDCA doses of 10 mgkg and 5 mgkg daily, and a control group receiving the standard dose of 13-15 mgkg daily. Treatment will last for at least one year, with evaluations every three months. These evaluations include symptom assessment, quality of life, liver function tests, blood and urine tests, immune markers, liver imaging, and tests of immune cells and cytokines. During the study, participants will undergo regular monitoring every three months to check for changes in symptoms, liver condition, and biochemical markers. The main outcome measured is the recurrence rate of PBC from baseline to months 3, 6, 9, and 12. This thorough follow-up helps researchers assess the safety and effects of reducing UDCA dosage, while participants continue to be monitored closely throughout the one-year study period.

Clinical Research of Tapering UDCA in PBC Patients With a Complete Response