A Phase 3, Global, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Investigate the Safety and Efficacy of Sofosbuvir/Velpatasvir/GS-9857 Fixed-Dose Combination for 12 Weeks in Direct-Acting Antiviral-Experienced Subjects With Chronic HCV Infection
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 416
- 主要终点
- Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12) (Primary Study)
研究概览
简要总结
The primary objectives of this study are to evaluate the safety and efficacy of treatment with sofosbuvir/velpatasvir/voxilaprevir (SOF/VEL/VOX) in adults with chronic hepatitis C virus (HCV) infection who have previously received treatment with direct-acting antiviral therapy.
Participants randomized to placebo may be eligible for deferred treatment with active SOF/VEL/VOX.
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
- Double (Participant, 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
- •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 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 (Primary Study)
SOF/VEL/VOX for 12 weeks
干预措施: SOF/VEL/VOX (Drug)
Placebo (Primary Study)
Placebo to match SOF/VEL/VOX for 12 weeks
干预措施: Placebo (Drug)
SOF/VEL/VOX (Deferred Treatment Substudy)
SOF/VEL/VOX for 12 weeks for eligible participants initially randomized to receive placebo
干预措施: SOF/VEL/VOX (Drug)
结局指标
主要结局
Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12) (Primary Study)
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 Discontinued Study Drug Due to an Adverse Event (Primary Study)
时间窗: Up to 12 weeks
次要结局
- Percentage of Participants With SVR at 4 Weeks After Discontinuation of Therapy (SVR4) (Primary Study)(Posttreatment Week 4)
- Percentage of Participants With HCV RNA < LLOQ On Treatment (Primary Study)(Weeks 1, 2, 4, 8 and 12)
- Change From Baseline in HCV RNA (Primary Study)(Baseline; Weeks 1, 2, 4, 8 and 12)
- Percentage of Participants With SVR at 24 Weeks After Discontinuation of Therapy (SVR24) (Primary Study)(Posttreatment Week 24)
- Percentage of Participants With Virologic Failure (Primary Study)(Up to Posttreatment Week 24)
- Percentage of Participants With SVR at 4, 12, and 24 Weeks After Discontinuation of Therapy (Deferred Treatment Substudy)(Posttreatment Weeks 4, 12, and 24 (Deferred Treatment Substudy))
- Percentage of Participants With HCV RNA < LLOQ On Treatment (Deferred Treatment Substudy)(Weeks 1, 2, 4, 8 and 12 (Deferred Treatment Substudy))
- Change From Baseline in HCV RNA (Deferred Treatment Substudy)(Baseline; Weeks 1, 2, 4, 8, and 12 (Deferred Treatment Substudy))
- Percentage of Participants With Virologic Failure (Deferred Treatment Substudy)(Up to Posttreatment Week 24 (Deferred Treatment Substudy))