NCT02201940已完成3 期
A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled 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
- 741
- 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 sofosbuvir/velpatasvir (SOF/VEL) fixed dose combination (FDC) for 12 weeks in adults with chronic genotype 1, 2, 4, 5, or 6 hepatitis C virus (HCV) infection.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •HCV genotype 1, 2, 4, 5, 6, or indeterminate assessed at screening by the central laboratory
- •Chronic HCV infection (≥ 6 months) documented by prior medical history or liver biopsy
- •Classification as treatment naive or treatment experienced
- •Males and females of childbearing potential who engage in heterosexual intercourse must agree to use protocol specified method(s) of contraception
排除标准
- •Current or prior history of 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
- •Prior exposure to SOF or other nucleotide analogue HCV NS5B inhibitor or any HCV NS5A inhibitor
- •Infection with hepatitis B virus (HBV) or human immunodeficiency virus (HIV)
研究组 & 干预措施
SOF/VEL
Experimental
SOF/VEL for 12 weeks
干预措施: SOF/VEL (Drug)
Placebo
Placebo Comparator
SOF/VEL placebo for 12 weeks
干预措施: Placebo (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
- Percentage of Participants With SVR at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)(Posttreatment Weeks 4 and 24)
- Percentage of Participants With HCV RNA < LLOQ at Weeks 1, 2, 4, 6, 8, 10, and 12(Weeks 1, 2, 4, 6, 8, 10, and 12)
- Change From Baseline in HCV RNA at Weeks 1, 2, 4, 6, 8, 10, and 12(Baseline; Weeks 1, 2, 4, 6, 8, 10, and 12)
- Percentage of Participants With Virologic Failure(Up to Posttreatment Week 24)
研究者
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