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Obeticholic Acid in Primary Biliary Cholangitis
NCT05450887Phase 3Completed
- Sponsor
- Nanjing Chia-Tai Tianqing Pharmaceutical
- Start
- Sep 2021
- Primary completion
- Mar 2024
- Modality
- Orthosteric Ligands
- Countries
- 1
01
Overview
Phase 3, randomised, double-blind trial in primary biliary cholangitis (PBC) comparing OCA 5-10 mg with Placebo (2 arms). Primary endpoint: Percentage of patients reaching composite endpoint (ALP < 1.67x ULN, ALP decrease >= 15%, Total Bilirubin <= ULN) at 12 months. Started Sep 2021; status: completed.
02
Drugs
obeticholic acid
03
Conditions
primary biliary cholangitis (PBC)
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