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

 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