A Phase 3b, Multicenter, Randomized, Open-Label Study to Investigate the Efficacy and Safety of Ledipasvir/Sofosbuvir Fixed-Dose Combination for 12 Weeks in Subjects With Chronic Genotype 2 HCV Infection
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 239
- 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 antiviral efficacy of therapy with ledipasvir/sofosbuvir (LDV/SOF) fixed-dose combination (FDC) and to evaluate the safety and tolerability of LDV/SOF FDC and sofosbuvir (SOF) + ribavirin (RBV) in participants with chronic genotype 2 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
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Chronic genotype 2 HCV-infected males and non-pregnant/non-lactating females
- •Aged 20 years or older
- •Treatment naive or treatment experienced
- •At least 20 subjects will have Child-Pugh-A compensated cirrhosis. In Cohort 2, participants must be ineligible or intolerant of RBV.
排除标准
- •Previous exposure to an NS5A or NS5B inhibitor
- •Infection with hepatitis B virus (HBV) or human immunodeficiency virus (HIV)
- •Pregnant or nursing female or male with pregnant female partner
- •Note: Other protocol defined Inclusion/Exclusion criteria may apply.
研究组 & 干预措施
LDV/SOF (Cohort 1)
LDV/SOF FDC for 12 weeks
干预措施: LDV/SOF (Drug)
SOF+RBV (Cohort 1)
SOF+RBV for 12 weeks
干预措施: SOF (Drug)
SOF+RBV (Cohort 1)
SOF+RBV for 12 weeks
干预措施: RBV (Drug)
LDV/SOF (Cohort 2)
Participants who are ineligible for or intolerant to RBV therapy will receive LDV/SOF FDC for 12 weeks.
干预措施: LDV/SOF (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
- Change From Baseline in HCV RNA at Week 2(Baseline; Week 2)
- Percentage of Participants With SVR at 4 Weeks After Discontinuation of Therapy (SVR4)(Posttreatment Week 4)
- Percentage of Participants With SVR at 24 Weeks After Discontinuation of Therapy (SVR24)(Posttreatment Week 24)
- Percentage of Participants With HCV RNA < LLOQ at Week 1(Week 1)
- Percentage of Participants With HCV RNA < LLOQ at Week 2(Week 2)
- Percentage of Participants With HCV RNA < LLOQ at Week 3(Week 3)
- Percentage of Participants With HCV RNA < LLOQ at Week 4(Week 4)
- Percentage of Participants With HCV RNA < LLOQ at Week 5(Week 5)
- Percentage of Participants With HCV RNA < LLOQ at Week 6(Week 6)
- Percentage of Participants With HCV RNA < LLOQ at Week 8(Week 8)
- Percentage of Participants With HCV RNA < LLOQ at Week 10(Week 10)
- Percentage of Participants With HCV RNA < LLOQ at Week 12(Week 12)
- Change From Baseline in HCV RNA at Week 1(Baseline; Week 1)
- Change From Baseline in HCV RNA at Week 3(Baseline; Week 3)
- Change From Baseline in HCV RNA at Week 4(Baseline; Week 4)
- Change From Baseline in HCV RNA at Week 5(Baseline; Week 5)
- Change From Baseline in HCV RNA at Week 6(Baseline; Week 6)
- Change From Baseline in HCV RNA at Week 8(Baseline; Week 8)
- Change From Baseline in HCV RNA at Week 10(Baseline; Week 10)
- Change From Baseline in HCV RNA at Week 12(Baseline; Week 12)
- Percentage of Participants With Overall Virologic Failure(Up to Posttreatment Week 24)