- Trial ID:
- Paul Pockros
- 1. Histologic evidence of NASH upon central read of a liver biopsy obtained no more than 6 months before Day 1 defined by presence of all 3 key histological features of NASH according to NASH CRN criteria.
- 2. Histologic evidence of fibrosis stage 2 or stage 3 as defined by the NASH CRN scoring of fibrosis, or
- Obesity (BMI ≥30 kg/m2)
- Type 2 diabetes diagnosed per 2013 American Diabetes Association criteria
- ALT >1.5× upper limit of normal (ULN).
- 3. For subjects with a historical biopsy, is either not taking or is on stable doses of TZDs/glitazones or vitamin E for 6 months before Day 1.
- 4. Stable body weight.
- 1. Model for End-stage Liver Disease (MELD) score >12
- 2. ALT ≥10× ULN
- 3. HbA1c >9.5%
- 4. Total bilirubin >1.5 mg/dL
- 5. Evidence of other known forms of known 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)
- 6. History of liver transplant, or current placement on a liver transplant list
- 7. Current or history of significant alcohol consumption
- 8. Prior or planned ileal resection, or prior or planned bariatric surgery
- 9. Histological presence of cirrhosis
- 10. History of biliary diversion
- 11. Known positivity for human immunodeficiency virus infection.
- 12. Acute cholecystitis or acute biliary obstruction.
- 13. BMI >45 kg/m2
Histologic evidence of fibrosis stage 1a or stage 1b if accompanied by ≥1 of the following risk factors:
Why isn't this trial accepting new patients?
The trial may have a limited enrollment number, reached its maximum, or come to the end of its enrollment period. View trials that are recruiting
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