Safety, Tolerability, and Efficacy of GS-4997 Alone or in Combination With Simtuzumab (SIM) in Adults With Nonalcoholic Steatohepatitis (NASH) and Fibrosis Stages F2-F3
Sponsored by Gilead Sciences
About this trial
Last updated 6 years ago
Study ID
Status
Type
Phase
Placebo
Accepting
Not accepting
Trial Timing
Ended 9 years ago
What is this trial about?
What are the Participation Requirements?
Key Inclusion Criteria:
- Males and non-pregnant, non-lactating females
- Evidence of NASH with fibrosis on biopsy
Key Exclusion Criteria:
- Cirrhosis of the liver (e.g. Brunt/Kleiner score of F4)
- Other causes of liver disease including viral hepatitis and alcoholic liver disease
- Any history of decompensated liver disease, including ascites, hepatic encephalopathy
or variceal bleeding
- History of liver transplantation
- Alcohol consumption greater than 21 oz/week for males or 14 oz/week for females (1
oz/30 mL of alcohol is present in 1 12 oz/360 mL beer, 1 4 oz/120 mL glass of wine,
and a 1 oz/30 mL measure of 40% proof alcohol)
Note: Other protocol defined Inclusion/Exclusion criteria may apply.