A Study of Response-Guided Duration of Combination Therapy With GS-9190, GS-9256, Pegasys® and Copegus® in Previously Untreated Subjects With Genotype 1 Chronic Hepatitis C
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Keep this study
Lead
Gilead Sciences
Age
18–70
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Adult subjects 18 to 70 years of age
Chronic HCV infection for at least 6 months prior to Baseline (Day 1)
Liver biopsy results (performed no more than 2 years prior to Screening) indicating the absence of cirrhosis
Monoinfection with HCV genotype 1a or 1b
HCV treatment-naïve
Body mass index (BMI) between 18 and 36 kg/m2
Creatinine clearance \>/= 50 mL/min
Subject agrees to use highly effective contraception methods if female of childbearing potential or sexually active male.
Screening laboratory values within defined thresholds for ALT, AST, leukopenia, neutropenia, anemia, thrombocytopenia, thyroid stimulating hormone (TSH), potassium, magnesium
You may not be if
Autoimmune disease
Decompensated liver disease or cirrhosis
Poorly controlled diabetes mellitus
Severe psychiatric illness
Severe chronic obstructive pulmonary disease (COPD)
Serological evidence of co-infection with human immunodeficiency virus (HIV), hepatitis B virus (HBV), or another HCV genotype
Suspicion of hepatocellular carcinoma or other malignancy (with exception of certain skin cancers)
History of hemoglobinopathy
Known retinal disease
Subjects who are immunosuppressed
Subjects with known, current use of amphetamines, cocaine, opiates (i.e., morphine, heroin), methadone, or ongoing alcohol abuse
Subjects who are on or are expected to be on a potent cytochrome P450 (CYP) 3A4 or Pgp inhibitor, or a QT prolonging medication within 2 weeks of Baseline (Day 1) or during the study
Subjects must have no history of clinically significant cardiac disease, including a family history of Long QT syndrome, and no relevant electrocardiogram (ECG) abnormalities at screening
Clareo Health | A Study of Response-Guided Duration of Combination Therapy With GS-9190, GS-9256, Pegasys® and Copegus® in Previously Untreated Subjects With Genotype 1 Chronic Hepatitis C
