drugset
drugset / Trial / NCT06715319

Obeticholic Acid Versus Placebo, in Combination with Ursodeoxycholic Acid in Patients with Primary Biliary Cirrhosis

NCT06715319 ↗

Phase 3 Completed 100 enrolled Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd.
RandomizedParallel-groupQuadruple-blindTreatment

Summary

This is a Phase III, randomized, double-blind, multicentre study assessing the efficacy and safety of obecholic acid and Ursodeoxycholic Acid(UDCA) compared with placebo and UDCA in treating of primary biliary cirrhosis (PBC) in adults with an inadequate response to UDCA.

Timeline

Start
2021-10-09
Primary completion
2023-10-16
Completion
2024-04-29

Drugs

EvaluationDrugModalityDoseRoute
Subject OCA Unknown 5 mg —
Subject OCA Unknown 10 mg —
Background Ursodeoxycholic Acid Small molecule 13 mg/kg —
Background Ursodeoxycholic Acid Small molecule 15 mg/kg —

Indications

primary biliary cholangitis