Study Evaluating the Efficacy and Safety of Obeticholic Acid in Subjects With Compensated Cirrhosis Due to Nonalcoholic Steatohepatitis

Exclusion Criteria

• •1. Current or past history of a clinically evident hepatic decompensation event, such as ascites, hepatic encephalopathy (HE), or variceal bleeding
• •2. Current or past history of CP score ≥7 points
• •3. Model for End-stage Liver Disease (MELD) score \> 12
• •4. ALT ≥ 5 X ULN
• •5. Calculated creatinine clearance \<60mL/min using Cockcroft-Gault method
• •6. Hemoglobin A1c (HbA1c) ≥ 9.5 %
• •7. Evidence of other known forms of chronic liver disease such as alcoholic liver disease, hepatitis B, hepatitis C, PBC, PSC, autoimmune hepatitis, Wilson disease, iron overload, alpha-1-antitrypsin deficiency, drug-induced liver injury, known or suspected hepatocellular carcinoma (HCC)
• •8. History of liver transplant, or current placement on a liver transplant list