clinical trial · NCT04594694
Study of OCA in Combination With BZF Evaluating Efficacy, Safety, and Tolerability in Participants With PBC
Intercept Pharmaceuticals·phase2·terminated·n = 75
Primary Biliary CholangitisObeticholic acidBezafibrate 200 MGOCA PlaceboBezafibrate 200 mg PlaceboBezafibrate 400 MGBezafibrate 400 mg PlaceboOCABezafibrate
brief summary
Study to evaluate the efficacy, safety, and tolerability of investigational drug obeticholic acid (OCA) in combination with the investigational drug bezafibrate (BZF) in participants with Primary Biliary Cholangitis (PBC).
started
Oct 2, 2019
primary completion
Oct 14, 2025
completion
Oct 14, 2025
last updated
Jul 16, 2026
official title
A Phase 2, Double-Blind, Randomized, Parallel Group Study Evaluating the Efficacy, Safety, and Tolerability of Obeticholic Acid Administered in Combination With Bezafibrate in Subjects With Primary Biliary Cholangitis Who Had an Inadequate Response or Who Were Unable to Tolerate Ursodeoxycholic Acid
sourced from ClinicalTrials.gov · pharmadog mirrors structured fields, not the full protocol