Obeticholic Acid (OCA) in Primary Sclerosing Cholangitis (PSC)
Status:
Completed
Trial end date:
2018-03-22
Target enrollment:
Participant gender:
Summary
This was a phase 2, double-blind (DB), placebo-controlled trial in participants with primary
sclerosing cholangitis to evaluate the effect of obeticholic acid on liver biochemistry, in
particular, serum alkaline phosphatase; and, safety. The long-term safety extension (LTSE)
phase was conducted to evaluate the safety, tolerability, and efficacy of long-term,
open-label use of OCA in participants with PSC who had completed the DB phase of the study.