Emricasan, a Caspase Inhibitor, for Treatment of Subjects With Decompensated NASH Cirrhosis

Exclusion Criteria

• •1. Evidence of severe decompensation
• •2. Non-cirrhotic portal hypertension
• •3. Child-Pugh score ≥10
• •4. Current use of anticoagulants that affect prothrombin time or international normalized ratio
• •5. ALT \>3 times upper limit of normal (ULN) or AST \>5 times ULN during screening
• •6. Initiation or discontinuation of non-selective beta blockers within 1 month of screening
• •7. Transjugular intrahepatic portosystemic shunt or other porto-systemic bypass procedure within 1 year of screening or previously requiring revision
• •8. Alpha-fetoprotein \>50 ng/mL in the last year
• •9. History of hepatocellular carcinoma (HCC) or evidence of HCC
• •10. History of malignancies other than HCC, unless successfully treated with curative intent and believed to be cured
• •11. Prior liver transplant
• •12. Uncontrolled diabetes mellitus (HbA1c \>9%)
• •13. Change in diabetes medications or vitamin E within 3 months of screening
• •14. Restrictive bariatric surgery or bariatric device within 1 year of screening or prior malabsorptive bariatric surgery
• •15. Symptoms of biliary colic unless resolved following cholecystectomy
• •16. History of significant alcohol consumption within the past 5 years
• •17. Current use of medications that are considered inhibitors of organic anion transporting polypeptide OATP1B1 and OATP1B3 transporters
• •18. Prolongation of screening (pre-treatment) QTcF interval of \>500 msecs, or history or presence of clinically concerning cardiac arrhythmias
• •19. Significant systemic or major illness other than liver disease
• •20. Human immunodeficiency virus infection
• •21. Use of alcohol, controlled substances (including inhaled or injected drugs), or non-prescribed use of prescription drugs within 1 year of screening to the point of interfering with the subject's ability to comply with study procedures and study drug administration in the investigator's judgement