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drugset / Trial / NCT04650243

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

NCT04650243 ↗

Phase 4 Recruiting 90 enrolled Peking Union Medical College Hospital
RandomizedParallel-groupOpen-labelTreatment

Summary

This study explores the feasibility of the reducing medication regimen for Ursodeoxycholic Acid(UDCA) in the treatment of primary biliary cholangitis. The participants will be distributed randomly into two experimental groups and one control group. The two experimental groups will receive reduced dosage of UDCA at different level, while the control group will receive standard dosage of UDCA. The effect of therapy will be evaluated every three months.

Timeline

Start
2020-01-21
Primary completion
2025-05
Completion
2025-05

Drugs

EvaluationDrugModalityDoseRoute
Subject Ursodeoxycholic Acid Small molecule 5 mg/kg Oral
Subject Ursodeoxycholic Acid Small molecule 10 mg/kg Oral
Subject Ursodeoxycholic Acid Small molecule 13 mg/kg Oral
Subject Ursodeoxycholic Acid Small molecule 15 mg/kg Oral

Indications

primary biliary cholangitis