A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of Selonsertib in Subjects With Compensated Cirrhosis Due to Nonalcoholic Steatohepatitis (NASH)
A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of Selonsertib in Subjects With Compensated Cirrhosis Due to Nonalcoholic Steatohepatitis (NASH)
The primary objective of this study is to evaluate whether selonsertib (SEL; GS-4997) can cause fibrosis regression and reduce associated complications in adults with cirrhosis due to NASH.
Key Inclusion Criteria:
Liver biopsy consistent with NASH and cirrhosis (F4 fibrosis) according to the NASH Clinical Research Network (CRN) classification, in the opinion of the central reader
Has the following laboratory parameters at the screening visit, as determined by the central laboratory:
Key Exclusion Criteria:
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
La Jolla, California 92093, United States
Los Angeles, California 90073, United States
San Francisco, California 94115, United States
Buffalo, New York 14230, United States
Manhasset, New York 11030, United States
Chapel Hill, North Carolina 27599, United States
Huntersville, North Carolina 28078, United States
Hershey, Pennsylvania 17033, United States
Philadelphia, Pennsylvania 19104, United States
Pittsburgh, Pennsylvania 15213, United States
Charleston, South Carolina 29425, United States
Greenville, South Carolina 29605, United States
Memphis, Tennessee 38104, United States
Nashville, Tennessee 37232, United States
Newport News, Virginia 23226, United States
Vancouver, British Columbia V5Z 1M9, Canada
Winnipeg, Manitoba R3E 3P4, Canada
Montreal, Quebec H4A 3JI, Canada
Bytom, 41-902, Poland
Bern, 3010, Switzerland