A Phase 2, Randomized, Open-Label Study of Ledipasvir/Sofosbuvir Fixed-Dose Combination and Vedroprevir With or Without Ribavirin in Treatment-Experienced Subjects With Chronic Genotype 1 HCV Infection and Cirrhosis
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 47
- 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 is to evaluate the antiviral efficacy, safety, and tolerability of combination therapy with ledipasvir/sofosbuvir (LDV/SOF) fixed-dose combination (FDC) + vedroprevir (VDV) ± ribavirin (RBV) for 8 weeks in treatment-experienced adults with chronic genotype 1 hepatitis C virus (HCV) infection and cirrhosis.
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 years, with chronic HCV genotype 1 infection
- •Documentation as treatment-experienced having received pegylated interferon (Peg-IFN) + RBV ≥ 4 weeks of duration without an additional agent in the regimen without achieving sustained viral response (SVR)
- •Presence of compensated cirrhosis
- •Screening laboratory values within defined thresholds
- •Must use specific contraceptive methods if female of childbearing potential or sexually active male
- •Not pregnant or a nursing female
排除标准
- •Co-infection 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 subject treatment, assessment or compliance with the protocol
研究组 & 干预措施
LDV/SOF+VDV
Participants will receive LDV/SOF+VDV for 8 weeks.
干预措施: LDV/SOF (Drug)
LDV/SOF+VDV
Participants will receive LDV/SOF+VDV for 8 weeks.
干预措施: VDV (Drug)
LDV/SOF+VDV+RBV
Participants will receive LDV/SOF+VDV+RBV for 8 weeks.
干预措施: LDV/SOF (Drug)
LDV/SOF+VDV+RBV
Participants will receive LDV/SOF+VDV+RBV for 8 weeks.
干预措施: VDV (Drug)
LDV/SOF+VDV+RBV
Participants will receive LDV/SOF+VDV+RBV for 8 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 8 weeks
次要结局
- Percentage of Participants With SVR at 4 Weeks After Discontinuation of Therapy (SVR4)(Posttreatment Week 4)