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Obeticholic Acid and UDCA in PBC Patients
NCT04956328Phase 3Unknown
- Sponsor
- Chia Tai-Tianqing Pharmaceutical Group
- Start
- Jul 2021
- Primary completion
- Sep 2023
- Modality
- Orthosteric Ligands
- Countries
- 1
01
Overview
Phase 3, randomised, double-blind trial in primary biliary cholangitis (PBC) comparing OCA 5-10mg + UDCA with Placebo + UDCA (2 arms). Primary endpoint: Percentage of PBC patients reaching the compound endpoint (ALP < 1.67x ULN, ALP decrease >= 15%, Total Bilirubin <= ULN) at 48 weeks. Status: unknown.
02
Drugs
obeticholic acid
03
Conditions
primary biliary cholangitis (PBC)
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