An Open-Label Study of GS-7977 + Ribavirin With or Without Peginterferon Alfa-2a in Subjects With Chronic HCV Infection Who Participated in Prior Gilead HCV Studies
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 534
- 试验地点
- 173
- 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 efficacy, safety, and tolerability of sofosbuvir (SOF; GS-7977) in combination with ribavirin (RBV) with or without pegylated interferon (Peg-IFN) in adults with chronic hepatitis C virus (HCV) infection who participated in a prior Gilead HCV study and have not achieved sustained virologic response (SVR).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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
- •Infection with HCV
- •Must have participated in a prior Gilead HCV study
- •Use of highly effective contraception methods if female of childbearing potential or sexually active male
- •Eligible patients include those in the following
- •received placebo or Peg-IFN+RBV in a control arm
- •previously participated in a Gilead-sponsored HCV study and did not attain sustained virologic response 24 weeks after discontinuation of therapy (SVR24) on a regimen containing:
- •Sofosbuvir+RBV
- •Peg-IFN and/or RBV in combination with one or more Gilead investigational direct-acting agents
排除标准
- •Pregnant or nursing female or male with pregnant female partner
- •Current or prior history of clinical hepatic decompensation
- •Infection with hepatitis B virus (HBV) or human immunodeficiency virus (HIV)
- •Chronic use of systemically administered immunosuppressive agents
- •Active drug abuse
- •Use of any prohibited concomitant medications
研究组 & 干预措施
SOF+RBV 12 Weeks
SOF+RBV for 12 weeks
干预措施: SOF (Drug)
SOF+RBV 12 Weeks
SOF+RBV for 12 weeks
干预措施: RBV (Drug)
SOF+RBV 24 Weeks
SOF+RBV for 24 weeks
干预措施: SOF (Drug)
SOF+RBV 24 Weeks
SOF+RBV for 24 weeks
干预措施: RBV (Drug)
SOF+RBV+Peg-IFN 12 Weeks
SOF+RBV+Peg-IFN for 12 weeks
干预措施: SOF (Drug)
SOF+RBV+Peg-IFN 12 Weeks
SOF+RBV+Peg-IFN for 12 weeks
干预措施: RBV (Drug)
SOF+RBV+Peg-IFN 12 Weeks
SOF+RBV+Peg-IFN for 12 weeks
干预措施: Peg-IFN (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, 25 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 24 weeks
次要结局
- Percentage of Participants With SVR at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)(Posttreatment Weeks 4 and 24)
- Percentage of Participants With On-treatment Virologic Failure(Up to 24 weeks)
- Percentage of Participants With Viral Relapse(Up to Posttreatment Week 24)