A Phase 2, Multicenter, Randomized, Open-Label Study to Evaluate the Efficacy and Safety of Sofosbuvir/Velpatasvir Fixed Dose Combination (FDC) and Sofosbuvir/Velpatasvir FDC and Ribavirin in Subjects With Chronic Genotype 3 HCV Infection and Cirrhosis
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 204
- 试验地点
- 27
- 主要终点
- Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Cessation 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 sofosbuvir/velpatasvir (SOF/VEL) fixed-dose combination (FDC) and SOF/VEL FDC and ribavirin (RBV) for 12 weeks in participants with chronic genotype 3 hepatitis C virus (HCV) infection and compensated cirrhosis.
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
- •Individuals with chronic genotype 3 HCV infection and compensated cirrhosis
- •Individuals with or without HIV-1 coinfection
排除标准
- •History of clinically significant illness or any other medical disorder that may interfere with individual's treatment assessment or compliance with the protocol
- •Co-infection with active hepatitis B virus
- •Laboratory results outside the acceptable ranges at screening
- •Pregnant or nursing female
- •Chronic liver disease not caused by HCV
- •Note: Other protocol defined Inclusion/Exclusion criteria may apply.
研究组 & 干预措施
SOF/VEL
SOF/VEL FDC for 12 weeks
干预措施: SOF/VEL (Drug)
SOF/VEL + RBV
SOF/VEL FDC + RBV for 12 weeks
干预措施: SOF/VEL (Drug)
SOF/VEL + RBV
SOF/VEL FDC + RBV for 12 weeks
干预措施: RBV (Drug)
结局指标
主要结局
Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Cessation of Therapy (SVR12)
时间窗: Posttreatment Week 12
SVR12 was defined as HCV RNA \< the lower limit of quantitation (LLOQ; ie, 15 IU/mL) at 12 weeks after stopping study treatment.
Percentage of Participants Who Permanently Discontinued Any Study Drug (Which Included SOF/VEL and RBV) Due to Any Adverse Event
时间窗: Posttreatment Week 12
次要结局
- HCV RNA at Week 8(Week 8)
- HCV RNA at Week 12(Week 12)
- Change From Baseline in HCV RNA at Week 2(Baseline; Week 2)
- Change From Baseline in HCV RNA at Week 4(Baseline; Week 4)
- Percentage of Participants Who Attain Sustained Virologic Response at 4 Weeks After Cessation of the Study Treatment Regimen (SVR4)(Posttreatment Week 4)
- Percentage of Participants Who Have HCV RNA < LLOQ at Week 2(Week 2)
- Percentage of Participants Who Have HCV RNA < LLOQ at Week 4(Week 4)
- Percentage of Participants Who Have HCV RNA < LLOQ at Week 8(Week 8)
- Percentage of Participants Who Have HCV RNA < LLOQ at Week 12(Week 12)
- HCV RNA at Week 2(Week 2)
- HCV RNA at Week 4(Week 4)
- Change From Baseline in HCV RNA at Week 8(Baseline; Week 8)
- Change From Baseline in HCV RNA at Week 12(Baseline; Week 12)
- Percentage of Participants With Virologic Failure(Up to Posttreatment Week 12)