A Phase 2, Randomized, Open-Label Study of Sofosbuvir/Ledipasvir Fixed-Dose Combination With Ribavirin or GS-9669 250 mg or GS-9669 500 mg in Naive or Treatment-Experienced Cirrhotic Subjects With Chronic Genotype 1 HCV Infection
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 101
- 主要终点
- Percentage of Participants Permanently Discontinuing Any Study Drug Due to an Adverse Event
研究概览
简要总结
This study will evaluate the antiviral efficacy of ledipasvir/sofosbuvir (LDV/SOF) fixed-dose combination (FDC) plus ribavirin (RBV) or LDV/SOF plus GS-9669 in treatment-naive or treatment-experienced participants with chronic genotype 1 hepatitis C virus (HCV) infection. A total of 90 participants are planned to be enrolled in the study for 8 weeks of treatment, approximately 60 having had prior treatment with a regimen containing pegylated interferon (PEG) and RBV for ≥ 12 weeks. Randomization will be stratified by treatment-naive versus treatment-experienced and by HCV genotype (1a versus 1b).
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
- •Documented HCV treatment-naïve or treatment-experienced subjects who failed previous PEG+RBV regimen
- •HCV RNA > 10,000 IU/mL at Screening
- •Presence of 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
- •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+RBV
Participants will receive LDV/SOF plus RBV for 8 weeks.
干预措施: LDV/SOF (Drug)
LDV/SOF+RBV
Participants will receive LDV/SOF plus RBV for 8 weeks.
干预措施: RBV (Drug)
LDV/SOF + GS-9669 250 mg
Participants will receive LDV/SOF plus GS-9669 250 mg for 8 weeks.
干预措施: LDV/SOF (Drug)
LDV/SOF + GS-9669 250 mg
Participants will receive LDV/SOF plus GS-9669 250 mg for 8 weeks.
干预措施: GS-9669 (Drug)
LDV/SOF + GS-9669 500 mg
Participants will receive LDV/SOF plus GS-9669 500 mg (2 x 250 mg) for 8 weeks.
干预措施: LDV/SOF (Drug)
LDV/SOF + GS-9669 500 mg
Participants will receive LDV/SOF plus GS-9669 500 mg (2 x 250 mg) for 8 weeks.
干预措施: GS-9669 (Drug)
结局指标
主要结局
Percentage of Participants Permanently Discontinuing Any Study Drug Due to an Adverse Event
时间窗: Up to 8 weeks
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) 12 weeks following the last dose of study drug.
次要结局
- Percentage of Participants With Sustained Virologic Response at 2, 4, 8, and 24 Weeks After Discontinuation of Therapy (SVR2, SVR4, SVR8, and SVR24)(Posttreatment Weeks 2, 4, 8, and 24)
- Percentage of Participants Experiencing Viral Relapse(Up to Posttreatment Week 24)
- Percentage of Participants Experiencing On-treatment Virologic Failure(Up to 8 weeks)