A Phase 3, Multicenter, Randomized, Open-Label Study to Investigate the Efficacy and Safety of Sofosbuvir/Velpatasvir Fixed-Dose Combination and Ribavirin for 12 or 24 Weeks in Subjects With Chronic Genotype 1 or 2 HCV Infection Who Have Previously Failed a Direct-Acting Antiviral-Containing Regimen
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 117
- 主要终点
- Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event
研究概览
简要总结
The primary objective of this study is to evaluate the antiviral efficacy, safety, and tolerability of therapy with sofosbuvir/velpatasvir (SOF/VEL) fixed-dose combination (FDC) and ribavirin (RBV) in participants with chronic genotype 1 or 2 hepatitis C virus (HCV) infection who have previously failed a direct-acting antiviral (DAA)-containing regimen.
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
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Genotype 1 or 2 HCV infection
- •Chronic HCV infection (≥ 6 months prior to screening) documented by prior medical history or liver biopsy
- •Previously treated with a DAA-containing regimen of at least 4 week duration
- •Note: Other protocol defined Inclusion/Exclusion criteria may apply.
排除标准
- 未提供
研究组 & 干预措施
SOF/VEL FDC + RBV 12 weeks
SOF/VEL FDC + RBV for 12 weeks in participants with genotype 1 or 2 HCV infection
干预措施: SOF/VEL (Drug)
SOF/VEL FDC + RBV 12 weeks
SOF/VEL FDC + RBV for 12 weeks in participants with genotype 1 or 2 HCV infection
干预措施: RBV (Drug)
SOF/VEL FDC + RBV 24 weeks
SOF/VEL FDC + RBV for 24 weeks in participants with genotype 1 or 2 HCV infection
干预措施: SOF/VEL (Drug)
SOF/VEL FDC + RBV 24 weeks
SOF/VEL FDC + RBV for 24 weeks in participants with genotype 1 or 2 HCV infection
干预措施: RBV (Drug)
结局指标
主要结局
Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event
时间窗: Up to 24 weeks
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; ie, 15 IU/mL) at 12 weeks after stopping study treatment.
次要结局
- Percentage of Participants With HCV RNA < LLOQ at Week 12(Week 12)
- Percentage of Participants With HCV RNA < LLOQ at Week 16(Week 16)
- Percentage of Participants With HCV RNA < LLOQ at Week 8(Week 8)
- Percentage of Participants With HCV RNA < LLOQ at Week 10(Week 10)
- Percentage of Participants With SVR at 24 Weeks After Discontinuation of Therapy (SVR24)(Posttreatment Week 24)
- Percentage of Participants With SVR at 4 Weeks After Discontinuation of Therapy (SVR4)(Posttreatment Week 4)
- Percentage of Participants With HCV RNA < LLOQ at Week 3(Week 3)
- Percentage of Participants With HCV RNA < LLOQ at Week 4(Week 4)
- Percentage of Participants With HCV RNA < LLOQ at Week 5(Week 5)
- Percentage of Participants With HCV RNA < LLOQ at Week 6(Week 6)
- Percentage of Participants With HCV RNA < LLOQ at Week 1(Week 1)
- Percentage of Participants With HCV RNA < LLOQ at Week 2(Week 2)
- Percentage of Participants With HCV RNA < LLOQ at Week 20(Week 20)
- Percentage of Participants With HCV RNA < LLOQ at Week 24(Week 24)
- Change From Baseline in HCV RNA at Week 1(Baseline; Week 1)
- Change From Baseline in HCV RNA at Week 2(Baseline; Week 2)
- Change From Baseline in HCV RNA at Week 3(Baseline; Week 3)
- Change From Baseline in HCV RNA at Week 4(Baseline; Week 4)
- Change From Baseline in HCV RNA at Week 5(Baseline; Week 5)
- Change From Baseline in HCV RNA at Week 6(Baseline; Week 6)
- Change From Baseline in HCV RNA at Week 8(Baseline; Week 8)
- Change From Baseline in HCV RNA at Week 10(Baseline; Week 10)
- Change From Baseline in HCV RNA at Week 12(Baseline; Week 12)
- Change From Baseline in HCV RNA at Week 16(Baseline; Week 16)
- Change From Baseline in HCV RNA at Week 20(Baseline; Week 20)
- Change From Baseline in HCV RNA at Week 24(Baseline; Week 24)
- Percentage of Participants With Overall Virologic Failure(Up to Posttreatment Week 24)