A Phase 3, Double-Blind, Randomized, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of Obeticholic Acid in Subjects With Compensated Cirrhosis Due to Nonalcoholic Steatohepatitis
A Phase 3, Double-Blind, Randomized, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of Obeticholic Acid in Subjects With Compensated Cirrhosis Due to Nonalcoholic Steatohepatitis
The primary objective of this study is to evaluate whether obeticholic acid (OCA; INT-747) can lead to histological improvement in fibrosis with no worsening of NASH in adults with compensated cirrhosis due to NASH.
Key inclusion criteria:
1. Subjects with a confirmed diagnosis of NASH and a fibrosis score of 4 based upon the NASH CRN scoring system determined by central reading
Key exclusion criteria:
Wyoming, Michigan 49519, United States
Buffalo, New York 14203, United States
Chapel Hill, North Carolina 27599, United States
Huntersville, North Carolina 28078, United States
Huntersville, North Carolina 28078, United States
Hershey, Pennsylvania 17033, United States
Pittsburgh, Pennsylvania 15213, United States
Nashville, Tennessee 37232, United States
Newport News, Virginia 23602, United States
Richmond, Virginia 23226, United States
Kingswood, New South Wales 2747, Australia
Halifax, Nova Scotia B3H 2Y9, Canada
Kyiv, 03049, Ukraine