Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Gilead Sciences
Age
18–65
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Adults with cirrhosis of the liver defined as an Ishak fibrosis stage ≥ 5
Liver biopsy consistent with NASH or cryptogenic cirrhosis
Exclusion of other causes of liver disease including viral hepatitis and alcoholic liver disease
The liver biopsy sample must be determined to be adequate for evaluation by the Central pathologist
Must have aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 10 x the upper limit of the normal range (ULN)
Must have serum creatinine \< 2.0 mg/dL
A negative serum pregnancy test is required for female subjects of childbearing potential
All sexually active female subjects of childbearing potential must agree to use a protocol recommended method of contraception during heterosexual intercourse throughout the study and for 90 days following the last dose of study medication
Lactating females must agree to discontinue nursing before starting study treatment
Male subjects, if not vasectomized, are required to use barrier contraception (condom plus spermicide) during heterosexual intercourse from the screening through the study completion and for 90 days following the last dose of study drug
Clinically significant cardiac disease
History of malignancy, other than non-melanomatous skin cancer, within 5 years prior to screening
Major surgical procedure within 30 days prior to screening or the presence of an open wound
Known hypersensitivity to the investigation product or any of its formulation excipients
History of bleeding diathesis within 6 months of screening
Unavailable for follow-up assessment or concern for subject's compliance with the protocol procedures;
Participation in an investigational trial of a drug or device within 30 days prior to screening
History of solid-organ transplant; poor venous access or requirement for permanent or semi-permanent central vein catheter such as portacath
You may not be if
Pregnant or breast feeding
Any history of hepatic decompensation including ascites, hepatic encephalopathy or variceal bleeding
Weight reduction surgery in the past 5 year
Child-Pugh-Turcotte (CPT) score \>7; Model for End-Stage Liver Disease (MELD) score \> 12 and Body Mass Index (BMI) \<18kg/m2
Positive for hepatitis C virus (HCV) RNA
Positive for HBsAg
Alcohol consumption greater than 21oz/week for males or 14oz/week for females
Clareo Health | Simtuzumab (SIM, GS-6624) in the Treatment of Cirrhosis Due to NASH
