A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Investigate the Efficacy and Safety of GS-7977+Ribavirin for 12 Weeks in Treatment Naive and Treatment Experienced Subjects With Chronic Genotype 2 or 3 HCV Infection.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 421
- 试验地点
- 77
- 主要终点
- Percentage of Participants With Sustained Virologic Response 12 Weeks After Discontinuation of Therapy (SVR12)
研究概览
简要总结
This study will evaluate the safety, tolerability, and antiviral efficacy of GS-7977 with ribavirin (RBV) in participants with genotype 2 or 3 hepatitis C virus (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
- Triple (Participant, Care Provider, Investigator)
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
- •Age > 18 with chronic genotype 2 or 3 HCV infection
- •HCV RNA > 10,000 IU/mL at screening
- •Subjects must be treatment naive or treatment experienced
- •Presence or absence of cirrhosis; a liver biopsy may be required
- •Healthy according to medical history and physical examination with the exception of HCV diagnosis
- •Agree to use two forms of highly effective contraception for the duration of the study and 6 months after the last dose of study medication
排除标准
- •Prior use of any other inhibitor of the HCV NS5B Polymerase
- •History of any other clinically significant chronic liver disease
- •Evidence of or history of decompensated liver disease
- •HIV or chronic hepatitis B virus (HBV) infection
- •Hepatocellular carcinoma (HCC) or other malignancy (with exception of certain resolved skin cancers)
- •Chronic use of immunosuppressive agents or immunomodulatory agents
- •History or current evidence of any condition, therapy, laboratory abnormality or other circumstance that might confound the results of the study, or interfere with the subject's participation for the full duration of the study or not be in the best interest of the subject in the opinion of the investigator
研究组 & 干预措施
Placebo 12 Weeks (GT2/3)
Placebo to match SOF + weight-based RBV (1000-1200 mg as 200 mg tablets in a divided daily dose) for 12 weeks in participants with genotype 2 or 3 HCV infection.
干预措施: Placebo to match SOF (Drug)
Placebo 12 Weeks (GT2/3)
Placebo to match SOF + weight-based RBV (1000-1200 mg as 200 mg tablets in a divided daily dose) for 12 weeks in participants with genotype 2 or 3 HCV infection.
干预措施: Placebo to match RBV (Drug)
SOF 12 Weeks (GT2/3)
Placebo to match SOF + weight-based RBV (1000-1200 mg as 200 mg tablets in a divided daily dose) for 12 weeks in participants with genotype 2 or 3 HCV infection.
干预措施: SOF (Drug)
SOF 12 Weeks (GT2/3)
Placebo to match SOF + weight-based RBV (1000-1200 mg as 200 mg tablets in a divided daily dose) for 12 weeks in participants with genotype 2 or 3 HCV infection.
干预措施: RBV (Drug)
SOF 24 Weeks (GT3)
SOF 400 mg tablet once daily + weight-based RBV (1000-1200 mg as 200 mg tablets in a divided daily dose) for 24 weeks in participants with genotype 3 HCV infection.
干预措施: SOF (Drug)
SOF 24 Weeks (GT3)
SOF 400 mg tablet once daily + weight-based RBV (1000-1200 mg as 200 mg tablets in a divided daily dose) for 24 weeks in participants with genotype 3 HCV infection.
干预措施: RBV (Drug)
结局指标
主要结局
Percentage of Participants With Sustained Virologic Response 12 Weeks After Discontinuation of Therapy (SVR12)
时间窗: Posttreatment Week 12
SVR12 was defined as HCV RNA \< the lower limit of quantitation (LLOQ, ie, \< 25 IU/mL) 12 weeks following the last dose of study drug. Data for this outcome measure was not collected for the Placebo 12 Weeks (GT2/3) group.
Adverse Events Leading to Permanent Discontinuation of Study Drug(s)
时间窗: Up to 24 weeks
The percentage of participants experiencing an adverse event leading to permanent discontinuation of study drug(s) was analyzed.
次要结局
- Percentage of Participants With Sustained Virologic Response at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)(Posttreatment Weeks 4 and 24)
- Percentage of Participants Experiencing Viral Breakthrough or Viral Relapse(Up to Posttreatment Week 24)