Trial intelligence / Profile preview

Long-Term Safety Extension of OCA and BZF in PBC

NCT06488911Phase 3Terminated

Sponsor
Intercept Pharmaceuticals
Start
Jul 2024
Primary completion
Oct 2025
Modality
Orthosteric Ligands
Countries
21
01

Overview

Phase 3, open-label, single-arm trial of obeticholic acid and bezafibrate in primary biliary cholangitis (PBC), sponsored by Intercept Pharmaceuticals. Primary endpoints: Number of Participants Reporting Treatment Emergent Adverse Events (TEAEs), Serious TEAEs and TEAEs Leading to Discontinuation at 12 months and Number of Participants Reporting Severe TEAEs at 12 months. Started Jul 2024; status: terminated.

02

Drugs

obeticholic acidbezafibrate
03

Conditions

primary biliary cholangitis (PBC)

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