Safety and Efficacy of Simtuzumab (SIM, GS-6624) in Adults With Advanced Liver Fibrosis But Not Cirrhosis Secondary to Non-Alcoholic Steatohepatitis (NASH)
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 chronic liver disease due to NASH defined as macrovesicular steatosis involving \> 5% of hepatocytes on a liver biopsy with associated lobular inflammation
Stage 3-4 fibrosis by Ishak score on a liver biopsy
Exclusion of other causes of liver disease including viral hepatitis and alcoholic liver disease
Must have aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 10 x Central Laboratory Upper Limit of Normal (clULN)
Must have serum creatinine \< 2.0 mg/dL
A negative serum pregnancy test is required for females of childbearing potential
All sexually active females of childbearing potential must agree to use a protocol recommended method of contraception during 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
Males, 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.
You may not be if
Pregnant or breast feeding
Cirrhosis of the liver
Any history of hepatic decompensation including ascites, hepatic encephalopathy or variceal bleeding
Weight reduction surgery in the past 5 years
Positive for hepatitis C virus (HCV) RNA
Positive for HBsAg
Alcohol consumption greater than 21oz/week for males or 14oz/week for females
Positive urine screen for amphetamines, cocaine or opiates (i.e. heroin, morphine) at screening.
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 individual's compliance with the protocol procedures;
Participation in an investigational trial of a drug or device within 30 days prior to screening
BMI \< 18 kg/m\^2
Clareo Health | Safety and Efficacy of Simtuzumab (SIM, GS-6624) in Adults With Advanced Liver Fibrosis But Not Cirrhosis Secondary to Non-Alcoholic Steatohepatitis (NASH)
