Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Gilead Sciences
Age
18–70
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Liver biopsy consistent with NASH and cirrhosis (F4 fibrosis) according to the NASH Clinical Research Network (CRN) classification, in the opinion of the central reader
Has the following laboratory parameters at the screening visit, as determined by the central laboratory:
* Alanine aminotransferase (ALT) ≤ 8 x upper limit of normal (ULN)
* Creatinine Clearance (CLcr) ≥ 30 milliliter/minute (mL/min), as calculated by the Cockcroft-Gault equation
* HbA1c ≤ 9.5% (or serum fructosamine ≤ 381 micromole (μmol) if HbA1c is unable to be resulted)
* International normalised ratio (INR) ≤ 1.4, unless due to therapeutic anti-coagulation
* Platelet count ≥ 100,000/μL
You may not be if
Prior history of decompensated liver disease including clinical ascites, hepatic encephalopathy (HE), or variceal bleeding
Child-Pugh (CP) score \> 7, as determined at screening, unless due to therapeutic anti-coagulation
Model for End-stage Liver Disease (MELD) score \> 12, as determined at screening, unless due to therapeutic anti-coagulation
Other causes of liver disease including, but not limited to, alcoholic liver disease, hepatitis B, hepatitis C, autoimmune disorders, drug-induced hepatotoxicity, Wilson disease, iron overload, and alpha-1-antitrypsin deficiency, based on medical history and/or centralized review of liver histology.
History of liver transplantation
Current or history of hepatocellular carcinoma (HCC)
Clareo Health | Safety and Efficacy of Selonsertib in Adults With Compensated Cirrhosis Due to Nonalcoholic Steatohepatitis (NASH)
