NCT02413593已完成2 期
A Phase 2 Open- Label Study to Evaluate The Safety and Efficacy of Ledipasvir/Sofosbuvir (LDV/SOF) Fixed Dose Combination Tablet With Ribavirin for 12 Weeks in Treatment-naïve Patients With Chronic HCV Genotype 3 Infection
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 111
- 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
This study will evaluate the antiviral efficacy, safety, and tolerability of ledipasvir/sofosbuvir (LDV/SOF) fixed dose combination (FDC) plus ribavirin (RBV) in treatment-naive adults with chronic genotype 3 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
- •Chronic genotype 3 HCV infection
- •HCV treatment-naive
- •HCV RNA > 10,000 IU/mL at screening
- •Absence of cirrhosis or compensated cirrhosis
- •Screening laboratory values within defined thresholds
- •Use of two effective contraception methods if female of childbearing potential or sexually active male
排除标准
- •Pregnant or nursing female or male with pregnant female partner
- •Coinfection with HIV or hepatitis B virus (HBV)
- •Current or prior history of clinical hepatic decompensation
- •Chronic use of systemic immunosuppressive agents
- •History of clinically significant illness or any other medical disorder that may interfere with the individual's treatment, assessment, or compliance with the protocol
- •Note: Other protocol defined Inclusion/Exclusion criteria may apply.
研究组 & 干预措施
LDV/SOF+RBV
Experimental
LDV/SOF FDC plus RBV for 12 weeks
干预措施: LDV/SOF (Drug)
LDV/SOF+RBV
Experimental
LDV/SOF FDC plus RBV for 12 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 12 weeks
次要结局
- Percentage of Participants With SVR at 4 Weeks After Discontinuation of Therapy (SVR4)(Posttreatment Week 4)
- Percentage of Participants With HCV RNA < LLOQ at Weeks 1, 2, 4, 8 and 12(Weeks 1, 2, 4, 8, and 12)
- Percentage of Participants With Virologic Failure(Up to Posttreatment Week 12)
- Change From Baseline in HCV RNA at Weeks 1, 2, 4, 8, and 12(Baseline; Weeks 1, 2, 4, 8, and 12)
研究者
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