Viable Clinical Research is conducting a clinical research study evaluating the efficacy and safety of obeticholic acid in subjects with compensated cirrhosis due to nonalcoholic steatohepatitis.
|Ages Eligible for Study:||18 Years and older|
|Genders Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- Subjects with a confirmed diagnosis of NASH and a fibrosis score of 4 based upon the NASH CRN scoring system determined by central reading.
- Current or past history of hepatic decompensation such as clinically significant ascites, hepatic encephalopathy (HE), or variceal bleeding;
- Current or past history of CP score > 7 points;
- Model for End-stage Liver Disease (MELD) score > 12;
- ALT > 5 X ULN;
- Calculated creatinine clearance < 60 ml/min using Cockcroft-Gault method;
- Hemoglobin A1c > 9.5%;
- 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);
- History of liver transplant, or current placement on a liver transplant list.