A Phase 2, Open-Label Study to Investigate the Safety and Efficacy of Sofosbuvir/GS-5816/GS-9857 Fixed-Dose Combination With or Without Ribavirin in Subjects With Chronic Genotype 1 HCV Infection Previously Treated With a Direct Acting Antiviral Regimen
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 49
- 试验地点
- 1
- 主要终点
- Percentage of Participants Who Permanently Discontinued SOF/VEL/VOX Due to an Adverse Event
研究概览
简要总结
The primary objective of this study is to evaluate the efficacy, safety, and tolerability of the treatment with sofosbuvir/velpatasvir/voxilaprevir (SOF/VEL/VOX) fixed dose combination (FDC) ± ribavirin (RBV) in participants with chronic genotype 1 hepatitis C virus (HCV) infection and prior treatment experience with a direct acting antiviral (DAA).
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
- •Individuals with chronic HCV genotype 1 infection
- •Documented as treatment experienced with a direct acting antiviral-containing regimen without achieving sustained viral response
- •Absence of cirrhosis or presence of compensated cirrhosis
- •Screening laboratory values within defined thresholds
- •Must use specific contraceptive methods if female of childbearing potential or sexually active male
排除标准
- •Co-infection with HIV or hepatitis B virus (HBV)
- •Current or prior history of clinical hepatic decompensation
- •Chronic use of systemic immunosuppressive agents
- •History of clinically significant illness or any other medical disorder that may interfere with individual's treatment, assessment or compliance with the protocol
- •Pregnant or a nursing female
- •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/VOX + RBV
SOF/VEL/VOX + RBV for 12 weeks
干预措施: SOF/VEL/VOX (Drug)
SOF/VEL/VOX + RBV
SOF/VEL/VOX + RBV for 12 weeks
干预措施: RBV (Drug)
结局指标
主要结局
Percentage of Participants Who Permanently Discontinued SOF/VEL/VOX Due to an Adverse Event
时间窗: Up to 12 weeks
Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Cessation of Treatment (SVR12)
时间窗: Posttreatment Week 12
SVR12 is defined as HCV RNA \< the lower limit of quantitation (LLOQ; ie, 15 IU/mL) at 12 weeks after stopping study treatment.
次要结局
- Percentage of Participants With HCV RNA < LLOQ on Treatment(Weeks 1, 2, 4, 8 and 12)
- Percentage of Participants With Virologic Failure(Up to Posttreatment Week 24)
- Percentage of Participants With SVR at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)(Posttreatment Weeks 4 and 24)
- HCV RNA Change From Baseline/Day 1 Through Week 12(Weeks 1, 2, 4, 8, and 12)