A Phase 3, Multicenter, Randomized, Open-Label Study to Compare the Efficacy and Safety of Sofosbuvir/GS-5816 Fixed Dose Combination for 12 Weeks With Sofosbuvir and Ribavirin for 24 Weeks in Subjects With Chronic Genotype 3 HCV Infection
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 558
- 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 compare the efficacy of treatment with sofosbuvir/velpatasvir (SOF/VEL) fixed-dose combination (FDC) for 12 weeks with that of sofosbuvir (SOF) + ribavirin (RBV) for 24 weeks and to evaluate the safety and tolerability of each treatment regimen in participants with chronic genotype 3 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
- 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
- •HCV genotype 3
- •Chronic HCV infection (≥ 6 months)
- •Females of childbearing potential must have a negative serum pregnancy test
- •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) that may interfere with subject treatment, assessment or compliance with the protocol
- •Screening ECG with clinically significant abnormalities
- •Laboratory results outside of acceptable ranges at Screening
- •Pregnant or nursing female or male with pregnant female partner
- •Chronic liver disease of a non-HCV etiology (e.g., hemochromatosis, Wilson's disease, alfa-1 antitrypsin deficiency, cholangitis)
- •Infection with hepatitis B virus (HBV) or human immunodeficiency virus (HIV)
研究组 & 干预措施
SOF/VEL 12 Weeks
SOF/VEL FDC for 12 weeks
干预措施: SOF/VEL (Drug)
SOF+RBV 24 Weeks
SOF+RBV for 24 weeks
干预措施: SOF (Drug)
SOF+RBV 24 Weeks
SOF+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 (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 24 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, 12, 16, 20, and 24(Weeks 1, 2, 4, 6, 8, 10, 12, 16, 20, and 24)
- Change From Baseline in HCV RNA at Weeks 1, 2, 4, 6, 8, 10, 12, 16, 20, and 24(Baseline; Weeks 1, 2, 4, 6, 8, 10, 12, 16, 20, and 24)
- Percentage of Participants With Virologic Failure(Up to Posttreatment Week 24)