A Phase 3, Multicenter, Randomized, Open-Label Study to Investigate the Efficacy and Safety of Sofosbuvir/GS-5885 Fixed-Dose Combination (FDC) +/- Ribavirin for 12 and 24 Weeks in Treatment-Naive Subjects With Chronic Genotype 1 HCV Infection.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 870
- 主要终点
- Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Study Drug (SVR12)
研究概览
简要总结
The purpose of this study is to evaluate the safety, tolerability, and antiviral efficacy of ledipasvir (LDV)/sofosbuvir (SOF) fixed-dose combination (FDC) tablets with or without ribavirin (RBV) administered for 12 and 24 weeks in treatment-naive subjects with chronic genotype 1 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
- •Age ≥ 18, with chronic genotype 1 HCV infection
- •HCV treatment-naive
- •HCV RNA > 10,000 IU/mL at screening
- •Cirrhosis determination; a liver biopsy may be required
- •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
- •Co-infection with HIV or hepatitis B virus (HBV)
- •Current or prior history of clinical hepatic decompensation
- •Hepatocellular carcinoma (HCC) or other malignancy (with exception of certain resolved skin cancers)
- •Chronic use of systemic immunosuppressive agents
- •History of clinically significant illness or any other medical disorder that may interfere with subject treatment, assessment or compliance with the protocol
研究组 & 干预措施
LDV/SOF 12 weeks
LDV/SOF administered for 12 weeks
干预措施: LDV/SOF (Drug)
LDV/SOF+RBV 12 weeks
LDV/SOF+RBV administered for 12 weeks.
干预措施: LDV/SOF (Drug)
LDV/SOF+RBV 12 weeks
LDV/SOF+RBV administered for 12 weeks.
干预措施: RBV (Drug)
LDV/SOF 24 weeks
LDV/SOF administered for 24 weeks
干预措施: LDV/SOF (Drug)
LDV/SOF+RBV 24 weeks
LDV/SOF+RBV administered for 24 weeks.
干预措施: LDV/SOF (Drug)
LDV/SOF+RBV 24 weeks
LDV/SOF+RBV administered 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 Study Drug (SVR12)
时间窗: Posttreatment Week 12
SVR12 was defined as HCV RNA level \< the lower limit of quantification (LLOQ, ie, \< 25 copies/mL) 12 weeks after last dose of study drug.
Incidence of Adverse Events Leading to Permanent Discontinuation From Any Study Drug
时间窗: Up to 24 weeks
The percentage of participants who experienced an adverse event leading to permanent discontinuation from any study drug was summarized.
次要结局
- Percentage of Participants With HCV RNA < LLOQ at Week 2(Week 2)
- Percentage of Participants With HCV RNA < LLOQ at Week 4(Week 4)
- Percentage of Participants With HCV RNA < LLOQ at Week 8(Week 8)
- Change From Baseline in HCV RNA at Week 2(Baseline; Week 2)
- Percentage of Participants With SVR at 4 and 24 Weeks After Discontinuation of Study Drug(Posttreatment Weeks 4 and 24)
- Change From Baseline in HCV RNA at Week 4(Baseline; Week 4)
- Change From Baseline in HCV RNA at Week 8(Baseline; Week 8)
- Percentage of Participants With Virologic Failure(Baseline to posttreatment Week 24)