A Phase 3b, Multicenter, Open-Label, Randomized Study to Investigate the Efficacy and Safety of Sofosbuvir Plus Ribavirin (± Pegylated Interferon) in Subjects With Chronic Genotype 1, 2, 3 and 6 HCV Infection
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 687
- 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
The primary objectives of this study are to evaluate the efficacy, safety and tolerability of treatment with sofosbuvir (SOF)+ ribavirin (RBV), with or without Pegylated interferon alfa (Peg-IFNα-2a/ PEG)) in participants with chronic genotype (GT)-1, 2, 3, and 6 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
- None
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
- •Willing and able to provide written informed consent
- •HCV RNA ≥ 10^4 IU/mL at screening
- •HCV treatment-naive (HCV genotype 1, 2, 3 or 6), defined as no prior exposure to any interferon (IFN), RBV, or other approved or experimental HCV-specific direct-acting antiviral agent, or HCV treatment-experienced (HCV genotype 1, 2, 3, or 6 only) with medical records that include sufficient detail of prior treatment with IFN to allow for categorization of prior response as either IFN Intolerant, non-responder, or experiences viral breakthrough or relapse
- •HCV infection documented by anti-HCV antibody test, genotyping test, or liver biopsy
排除标准
- •Current or prior history of any clinically-significant illness (other than HCV)
- •Pregnant or nursing female or male with pregnant female partner
- •Chronic liver disease of a non-HCV etiology
- •Infection with hepatitis B virus (HBV) or human immunodeficiency virus (HIV)
- •Note: Other protocol defined Inclusion/Exclusion criteria may apply.
研究组 & 干预措施
Sofosbuvir+RBV+PEG 12 weeks
Participants with genotype 1 or 6 will receive sofosbuvir+RBV+Peg-IFNα-2a for 12 weeks.
干预措施: Sofosbuvir (Drug)
Sofosbuvir+RBV+PEG 12 weeks
Participants with genotype 1 or 6 will receive sofosbuvir+RBV+Peg-IFNα-2a for 12 weeks.
干预措施: RBV (Drug)
Sofosbuvir+RBV+PEG 12 weeks
Participants with genotype 1 or 6 will receive sofosbuvir+RBV+Peg-IFNα-2a for 12 weeks.
干预措施: PEG (Drug)
Sofosbuvir+RBV 12 weeks
Participants with genotype 1, 2 or 6 will receive sofosbuvir+RBV for 12 weeks.
干预措施: Sofosbuvir (Drug)
Sofosbuvir+RBV 12 weeks
Participants with genotype 1, 2 or 6 will receive sofosbuvir+RBV for 12 weeks.
干预措施: RBV (Drug)
Sofosbuvir+RBV 16 weeks
Participants with genotype 1, 6 will receive sofosbuvir+RBV for 16 weeks.
干预措施: Sofosbuvir (Drug)
Sofosbuvir+RBV 16 weeks
Participants with genotype 1, 6 will receive sofosbuvir+RBV for 16 weeks.
干预措施: RBV (Drug)
Sofosbuvir+RBV 24 Weeks
Participants with genotype 1, 3, or 6 will receive sofosbuvir+RBV for 24 weeks.
干预措施: Sofosbuvir (Drug)
Sofosbuvir+RBV 24 Weeks
Participants with genotype 1, 3, or 6 will receive sofosbuvir+RBV for 24 weeks.
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 is defined as HCV RNA \< the lower limit of quantification (LLOQ; ie, \< 25 IU/mL) 12 weeks following the last dose of study drug.
Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event
时间窗: Up to 24 weeks
次要结局
- Percentage of Participants With Sustained Virologic Response 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)(Posttreatment Weeks 4 and 24)
- Change From Baseline in HCV RNA (log10 IU/mL)(Up to 24 weeks)
- Percentage of Participants With On-Treatment Virologic Failure(Up to 24 weeks)
- Percentage of Participants With Viral Relapse(Up to Posttreatment Week 24)