Phase 2 Study on Effects of Obeticholic Acid (OCA) on Lipoprotein Metabolism in Participants With Primary Biliary Cirrhosis

PHASE2CompletedINTERVENTIONAL
Enrollment

27

Participants

Timeline

Start Date

December 3, 2013

Primary Completion Date

August 13, 2014

Study Completion Date

September 12, 2016

Conditions
Primary Biliary Cirrhosis
Interventions
DRUG

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.

Trial Locations (7)

10003

Beth Israel Medical Center, New York

23249

McGuire DVAMC, Richmond

33136

University of Miami, Miami

46202

Indiana University Medical Center, Indianapolis

92037

Scripps Clinic, La Jolla

95817

University of California, Davis Medical Center, Sacramento

98104

Swedish Medical Center, Seattle

Sponsors
All Listed Sponsors
lead

Intercept Pharmaceuticals

INDUSTRY