NCT02308111.

Trial name or title	A Phase 3b, Double‐Blind, Randomized, Placebo‐Controlled, Multicenter Study Evaluating the Effect of Obeticholic Acid on Clinical Outcomes in Patients With Primary Biliary Cirrhosis
Methods	Phase 3, double‐blind, randomised, placebo‐controlled, multicentre study.
Participants	People with primary biliary cholangitis.
Interventions	Group 1: obeticholic acid. Further details: obeticholic acid 5 mg to 10 mg tablets once daily for the duration of the study based on tolerability at 3 months. Group 2: placebo. Further details: 1 tablet daily for the remainder of the study.
Outcomes	Mortality, liver transplantation, liver decompensation, hepatocellular carcinoma.
Starting date	December 2014.
Contact information	dshapiro@interceptpharma.com
Notes	Status: recruiting.