Trial intelligence / Profile preview

Phase 4 study of obeticholic acid on clinical outcomes in primary biliary cholangitis

2014-005012-42Phase 4Completed

Sponsor
Intercept Pharmaceuticals
Start
Sep 2015
Modality
Orthosteric Ligands → Classical Binding Small Molecules → Small Molecules
Countries
1
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Overview

Phase 4, randomised, double-blind trial in primary biliary cholangitis (PBC) comparing Obeticholic acid + standard of care with Placebo + standard of care (2 arms). Primary endpoint: Time to first occurrence of a composite clinical event endpoint. Started Sep 2015; status: completed.

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Drugs

obeticholic acid
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Conditions

primary biliary cholangitis (PBC)

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