A Phase IIa, Double-blind, Randomised, Placebo-Controlled Dose Escalation Study to Evalulate the Safety, Tolerability, Pharmacokinetics and Activity of GS-9450, a Caspase Inhibitor, in Subjects with Chronic Hepatitis C

Gilead Sciences Incorporated0 个研究点目标入组 32 人开始时间: 2007年4月2日最近更新: 2012年6月26日

研究概览

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•Adult subjects, ages 18-65 infected with chronic HCV of any genotype who have previously been treated with RIBA and/or INF (or pegylated interferon) who either 1) did not achieve or maintain a sustained virologic response after RIBA and/or INF or 2) did not tolerate RIBA and/or INF treatment.
•Alternatively, subjects may be eligible if they have contraindications to receiving INF and/or RIBA therapy
•ALT = 1.5 x ULN but < 10 x ULN
•BMI between 19 and 32 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 (i.e., subjects must have platelets = 75,000/mm3, total bilirubin = 1.5 x ULN, prothrombin time = 1.5 x ULN and albumin = 3.0 g/dL).
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•decompensated liver disease
•evidence of hepatocellular carcinoma (i.e., alpha-fetoprotein 50 ng/mL)
•positive urine drug screen for opiates, cocaine or amphetamines
•co-infection with hepatitis B virus (HBV)
•human immunodeficiency virus (HIV); pancreatitis
•recent significant infection or symptoms of infection (including mononucleosis or active herpes simplex virus)
•autoimmune disorders
•transplantation
•history of malignancy
•ongoing alcohol abuse (defined as intake of more than 28 units of alcohol per week

发起方

Gilead Sciences Incorporated