27
Participants
Start Date
December 3, 2013
Primary Completion Date
August 13, 2014
Study Completion Date
September 12, 2016
Obeticholic Acid
All participants were treated with OCA (oral administration, 10 mg, once daily \[QD\]) for 8 weeks and continued their prestudy dose of ursodeoxycholic acid (UDCA). After completion of the 8-week Primary Treatment Phase of the study and the 4-week follow-up period, during which time participants did not take OCA, all eligible participants were offered the opportunity to enter an open-label, long-term safety extension phase, during which they could receive 10 mg OCA QD for up to 2 years.
Beth Israel Medical Center, New York
McGuire DVAMC, Richmond
University of Miami, Miami
Indiana University Medical Center, Indianapolis
Scripps Clinic, La Jolla
University of California, Davis Medical Center, Sacramento
Swedish Medical Center, Seattle
Lead Sponsor
Intercept Pharmaceuticals
INDUSTRY