A Phase 2 Randomized, Open-Label Study of GS-5885 Administered Concomitantly With GS-9451, Tegobuvir and Ribavirin (RBV) to Treatment-Naive Subjects With Chronic Genotype 1 HCV Infection
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 141
- 试验地点
- 43
- 主要终点
- Sustained virologic response (SVR)
研究概览
简要总结
The purpose of this phase 2 study is to determine whether 30 mg or 90 mg of GS-5885 when given with GS-9451, Tegobuvir and Ribavirin (RBV) for 12 or 24 weeks is effective, safe and tolerable in the treatment of Chronic Genotype 1 HCV Infection.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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 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
研究组 & 干预措施
Arm 1
GS-5885, GS-9451 and Tegobuvir in combination with ribavirin (Copegus®) for 24 weeks.
干预措施: GS-5885 (Drug)
Arm 1
GS-5885, GS-9451 and Tegobuvir in combination with ribavirin (Copegus®) for 24 weeks.
干预措施: Tegobuvir (Drug)
Arm 1
GS-5885, GS-9451 and Tegobuvir in combination with ribavirin (Copegus®) for 24 weeks.
干预措施: GS-9451 (Drug)
Arm 1
GS-5885, GS-9451 and Tegobuvir in combination with ribavirin (Copegus®) for 24 weeks.
干预措施: ribavirin tablet (Drug)
Arm 2
GS-5885, GS-9451 and Tegobuvir in combination with ribavirin (Copegus®) for 12 or 24 weeks.
干预措施: Tegobuvir (Drug)
Arm 2
GS-5885, GS-9451 and Tegobuvir in combination with ribavirin (Copegus®) for 12 or 24 weeks.
干预措施: GS-9451 (Drug)
Arm 2
GS-5885, GS-9451 and Tegobuvir in combination with ribavirin (Copegus®) for 12 or 24 weeks.
干预措施: ribavirin tablet (Drug)
Arm 2
GS-5885, GS-9451 and Tegobuvir in combination with ribavirin (Copegus®) for 12 or 24 weeks.
干预措施: GS-5885 (Drug)
结局指标
主要结局
Sustained virologic response (SVR)
时间窗: 24 weeks of off-treatment follow-up
次要结局
- HCV RNA < Lower Limit Of Quantification(Weeks 1, 2, 4, 12 and 24)
- Emergence of viral resistance(12 or 24 weeks)
- Pharmacokinetics of GS-5885, GS-9451 and Tegobuvir when administered in combination with RBV(Through Week 2 of therapy)
- Safety and tolerability(through 24 weeks of off-treatment follow-up)
- Rescue Therapy Substudy SVR(24 Weeks)
- Viral dynamics of GS-5885, GS-9451 and Tegobuvir when administered in combination with RBV(Through Week 2 of therapy)