A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study of GS-5885, GS-9451, Tegobuvir and Ribavirin; GS-5885, GS-9451 and Tegobuvir; GS-5885, GS-9451 and Ribavirin in Interferon Ineligible or Intolerant Subjects With Chronic Genotype 1a or 1b HCV Infection (Protocol No. GS US 248 0132)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 163
- 试验地点
- 49
- 主要终点
- Safety and Tolerability
研究概览
简要总结
This is a Phase 2 Randomized, Double-Blind, Placebo-Controlled Study of GS-5885, GS-9451, Tegobuvir and Ribavirin; GS-5885, GS-9451 and Tegobuvir; GS-5885, GS-9451 and Ribavirin in Interferon Ineligible or Intolerant Subjects with Chronic Genotype 1a or 1b 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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult subjects 18 and older with chronic HCV infection
- •Liver biopsy results (performed no more than 3 years prior to Screening) indicating the absence of cirrhosis
- •Monoinfection with HCV genotype 1a or 1b
- •Interferon ineligible or intolerant
- •Body mass index (BMI) between 18 and 40 kg/m2
- •Use of highly effective contraception methods if female of childbearing potential or sexually active male
- •Screening laboratory values within defined thresholds
- •Has not been exposed to any investigational drug or device within 30 days of the Screening visit
- •Able to comply with the dosing instructions for study drug administration and able to complete the study schedule of assessments
排除标准
- •Prior treatment of HCV with any direct-acting antiviral (whether approved or experimental)
- •Decompensated liver disease or cirrhosis
- •Co-infection with human immunodeficiency virus (HIV), hepatitis B virus (HBV), or another HCV genotype
- •History of difficulty with blood collection and/or poor venous access
- •Pregnant or nursing female or male with pregnant female partner
- •Chronic liver disease of a non-HCV etiology
- •Suspicion of hepatocellular carcinoma
- •Clinically-relevant drug abuse
研究组 & 干预措施
Arm 1
GS-5885, GS-9451, tegobuvir (GS-9190), and Copegus® for 24 weeks
干预措施: GS-5885 tablet (Drug)
Arm 1
GS-5885, GS-9451, tegobuvir (GS-9190), and Copegus® for 24 weeks
干预措施: GS-9451 tablet (Drug)
Arm 1
GS-5885, GS-9451, tegobuvir (GS-9190), and Copegus® for 24 weeks
干预措施: tegobuvir capsule (Drug)
Arm 1
GS-5885, GS-9451, tegobuvir (GS-9190), and Copegus® for 24 weeks
干预措施: ribavirin tablet (Drug)
Arm 2
GS-5885, GS-9451, tegobuvir (GS-9190), and a placebo matching ribavirin for 24 weeks
干预措施: GS-5885 tablet (Drug)
Arm 2
GS-5885, GS-9451, tegobuvir (GS-9190), and a placebo matching ribavirin for 24 weeks
干预措施: GS-9451 tablet (Drug)
Arm 2
GS-5885, GS-9451, tegobuvir (GS-9190), and a placebo matching ribavirin for 24 weeks
干预措施: tegobuvir capsule (Drug)
Arm 2
GS-5885, GS-9451, tegobuvir (GS-9190), and a placebo matching ribavirin for 24 weeks
干预措施: placebo matching ribavirin tablet (Drug)
Arm 3
GS-5885, GS-9451, a placebo matching tegobuvir, and Copegus® for 24 weeks
干预措施: GS-5885 tablet (Drug)
Arm 3
GS-5885, GS-9451, a placebo matching tegobuvir, and Copegus® for 24 weeks
干预措施: GS-9451 tablet (Drug)
Arm 3
GS-5885, GS-9451, a placebo matching tegobuvir, and Copegus® for 24 weeks
干预措施: ribavirin tablet (Drug)
Arm 3
GS-5885, GS-9451, a placebo matching tegobuvir, and Copegus® for 24 weeks
干预措施: placebo matching tegobuvir capsule (Device)
结局指标
主要结局
Safety and Tolerability
时间窗: Through 24 weeks of off-treatment follow-up
To evaluate safety and tolerability of combination therapy with GS-5885, GS-9451, tegobuvir and ribavirin or GS-5885, GS-9451 and tegobuvir or GS-5885, GS-9451 and ribavirin. Safety will be assessed during the study through the reporting of adverse events, clinical laboratory tests, physical examinations, vital signs and 12-lead ECGs at various time points during the study.
Antiviral Activity
时间窗: Through 24 weeks of off-treatment follow-up
To evaluate antiviral efficacy as measured by sustained virologic response (defined as HCV RNA \< lower limit of quantitation 24-weeks post-treatment) of combination therapy with GS-5885, GS-9451, tegobuvir and ribavirin or GS-5885, GS-9451 and tegobuvir or GS-5885, GS-9451 and ribavirin.
次要结局
- Composite (or Profile) of Pharmacokinetics(predose, 1, 2, 3, 4, 6, 8, 10, 12 and 24 hours post-dose)
- Viral Dynamics(Through 10 days of therapy)