NCT02671500已完成3 期
A Phase 3, Multicenter, Open-Label Study to Investigate the Efficacy and Safety of Sofosbuvir/GS-5816 Fixed Dose Combination for 12 Weeks in Subjects With Chronic HCV
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 375
- 试验地点
- 38
- 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 this study are to evaluate the efficacy, safety, and tolerability of treatment with sofosbuvir (SOF)/velpatasvir (VEL; GS-5816) fixed-dose combination (FDC) for 12 weeks in participants with chronic hepatitis C virus (HCV) infection.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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) documented by prior medical history or liver biopsy
- •Any HCV genotype (1, 2, 3, 4, 5, 6 or indeterminate)
- •HCV treatment-naive or treatment-experienced
- •Liver imaging within 6 months of Day 1 is required in cirrhotic patients only to exclude hepatocellular carcinoma (HCC)
排除标准
- •Current or prior history of clinically-significant illness (other than HCV), gastrointestinal disorder, clinical hepatic decompensation, or post-operative condition that could interfere with the absorption of the study drug
- •Pregnant or nursing female or male with pregnant female partner
- •Chronic liver disease of a non HCV etiology
- •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
Experimental
SOF/VEL FDC 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; ie, 15 IU/mL) at 12 weeks after stopping study treatment.
Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event
时间窗: Up to 12 weeks
次要结局
- Change From Baseline in HCV RNA(Baseline and up to Week 12)
- Percentage of Participants With Overall Virologic Failure(Up to Posttreatment Week 24)
- Percentage of Participants With HCV RNA < LLOQ On Treatment(Weeks 1, 2, 4, 6, 8, 10, and 12)
- Percentage of Participants With SVR at 4 Weeks After Discontinuation of Therapy (SVR4)(Posttreatment Week 4)
- Percentage of Participants With SVR at 24 Weeks After Discontinuation of Therapy (SVR24)(Posttreatment Week 24)
研究者
研究点 (38)
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