A Phase 3, Global, Multicenter, Randomized, Open-Label Study to Investigate the Safety and Efficacy of Sofosbuvir/Velpatasvir/GS-9857 Fixed-Dose Combination for 12 Weeks and Sofosbuvir/Velpatasvir for 12 Weeks in Direct-Acting Antiviral-Experienced Subjects With Chronic HCV Infection Who Have Not Received an NS5A Inhibitor
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 333
- 主要终点
- Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12)
研究概览
简要总结
The primary objectives of the study are to evaluate the efficacy, safety, and tolerability of treatment with sofosbuvir/velpatasvir/voxilaprevir (Vosevi®; SOF/VEL/VOX) fixed-dose combination (FDC) for 12 weeks and of sofosbuvir/velpatasvir (Epclusa®; SOF/VEL) FDC for 12 weeks in direct-acting antiviral (DAA)-experienced adults with chronic hepatitis C virus (HCV) infection with or without cirrhosis who have not received prior treatment with a regimen containing an inhibitor of the HCV NS5A protein.
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
- •Chronic HCV infection (≥ 6 months)
- •Treatment experienced with a direct acting antiviral medication not including a NS5A Inhibitor for HCV
- •Use of protocol specified methods of contraception
排除标准
- •Current or prior history of clinically significant illness that may interfere with participation in the study
- •Screening ECG with clinically significant abnormalities
- •Laboratory results outside of acceptable ranges at screening
- •Pregnant or nursing female
- •Chronic liver disease not caused by HCV
- •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
SOF/VEL/VOX
SOF/VEL/VOX for 12 weeks
干预措施: SOF/VEL/VOX (Drug)
SOF/VEL
SOF/VEL for 12 weeks
干预措施: SOF/VEL (Drug)
结局指标
主要结局
Percentage of Participants With Sustained Virologic Response (SVR) 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) at 12 weeks after stopping study treatment.
Percentage of Participants Who Permanently Discontinue Study Drug Due to an Adverse Event
时间窗: Up to 12 weeks
次要结局
- Percentage of Participants With SVR at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)(Posttreatment Weeks 4 and 24)
- Percentage of Participants With HCV RNA < LLOQ On Treatment(Weeks 1, 2, 4, 8 and 12)
- Change From Baseline in HCV RNA(Weeks 1, 2, 4, 8, and 12)
- Percentage of Participants With Virologic Failure(Up to Posttreatment Week 24)