An Open Label Study to Evaluate The Efficacy And Safety Of Sofosbuvir/GS-5816 Fixed Dose Combination With Ribavirin For 24 Weeks In Chronic HCV Infected Subjects Who Participated In A Prior Gilead Sponsored HCV Treatment Study
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 69
- 主要终点
- Percentage of Participants With Sustained Virologic Response 12 Weeks After Discontinuation of Therapy (SVR12)
研究概览
简要总结
The primary objective of this study is to evaluate the efficacy, safety and tolerability of treatment with sofosbuvir/velpatasvir (Epclusa®; SOF/VEL) with ribavirin (RBV) for 24 weeks in adults with chronic hepatitis C virus (HCV) infection who participated in a prior Gilead sponsored study and did not achieve sustained virologic response (SVR).
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 genotype determined by the Central Laboratory
- •HCV RNA > LLOQ at screening
- •Participated and completed a Gilead sponsored HCV treatment study of direct acting antiviral (DAA) containing regimens.
- •Male and female of childbearing potential must agree to use protocol specified method(s) of contraception
排除标准
- •Current or prior history: Clinically-significant illness (other than HCV) or any other major medical disorder that may interfere with treatment, assessment or compliance with the protocol; individuals currently under evaluation for a potentially clinically-significant illness (other than HCV) are also excluded.
- •Screening ECG with clinically significant abnormalities
- •Laboratory results outside of acceptable ranges at screening
- •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+RBV
Participants will receive SOF/VEL fixed dose combination (FDC) and RBV for 24 weeks.
干预措施: SOF/VEL (Drug)
SOF/VEL+RBV
Participants will receive SOF/VEL fixed dose combination (FDC) and RBV for 24 weeks.
干预措施: RBV (Drug)
结局指标
主要结局
Percentage of Participants With Sustained Virologic Response 12 Weeks After Discontinuation of Therapy (SVR12)
时间窗: Posttreatment Week 12
SVR12 is defined as HCV RNA \< the lower limit of quantitation (LLOQ) 12 weeks following the last dose of study drug.
Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event
时间窗: Up to 24 weeks
次要结局
- Percentage of Participants With Sustained Virologic Response 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)(Posttreatment Weeks 4 and 24)
- Percentage of Participants With HCV RNA < LLOQ On-treatment(Baseline to Week 24)
- HCV RNA Change From Baseline(Baseline to Week 24)
- Percentage of Participants With Virologic Failure(Up to Posttreatment Week 24)