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
Adult subjects, ages 18-65
Chronic HCV infection, defined as having documented HCV infection (antibody or RNA positivity) at least 6 months prior to Baseline (Day 1) with HCV viremia at screening
Screening Knodell necroinflammatory score \>= 3 based on liver biopsy evaluation (as determined by local pathologist) conducted anytime during the 45-day screening period
ALT \> the upper limit of the normal range (ULN) but \< 10 X ULN at the screening visit
Previously failed pegylated interferon-based HCV therapy in combination with ribavirin therapy, or is unable to tolerate or has contraindications to receiving interferon or ribavirin therapy
BMI between 19 and 36 kg/m2 (inclusive)
Creatinine clearance \>= 70 mL/min
absolute neutrophil count \>= 1000/mm3
Hemoglobin \> 10 g/dL
Have no clinical or laboratory evidence of hepatic decompensation
You may not be if
Decompensated liver disease
Child-Pugh grade B or C cirrhosis
Evidence of hepatocellular carcinoma
Positive urine drug screen for cocaine or amphetamines
Infection with HCV genotype 3
Co-infection with hepatitis B virus or human immunodeficiency virus
Pancreatitis
Recent significant infection or symptoms of infection
Autoimmune disorders
Any history of seizure
Is a public transportation operator (pilot of airplane or ship; air traffic controller; bus, train or subway driver) or operates heavy construction machinery
Transplantation
History of malignancy
Current excessive alcohol ingestion, averaging \> 3 drinks/day for females and \> 4 drinks/day for males
History of or current binge drinking
Clareo Health | Efficacy and Safety Study of GS-9450 Treatment for 6 Months in Patients With Chronic Hepatitis C Virus Infection
