A Phase 3b, Multicenter, Randomized, Open-Label, Study to Evaluate the Safety and Efficacy of Sofosbuvir Plus Ribavirin in Treatment-Naïve Adults With Genotype 1 and 3 Chronic HCV Infection.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 127
- 试验地点
- 16
- 主要终点
- Incidence of Adverse Events Leading to Permanent Discontinuation of Study Drug(s)
研究概览
简要总结
This study will evaluate the antiviral efficacy, safety, and tolerability of sofosbuvir plus ribavirin administered for 16 weeks and 24 weeks in participants with chronic genotype 1 (GT1) or genotype 3 (GT3) 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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Confirmed chronic genotype 1 or 3 HCV infection
- •HCV treatment-naive
- •Individuals will have cirrhosis status assessment; liver biopsy may be required.
- •Screening laboratory values within predefined 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
- •Infection with hepatitis B virus (HBV) or human immunodeficiency virus (HIV)
- •Contraindication to ribavirin therapy
- •Excessive alcohol ingestion as defined by protocol
- •History of solid organ transplantation
- •Current or prior history of clinical hepatic decompensation
- •History of clinically significant illness or any other medical disorder that may interfere with the individual's treatment, assessment, or compliance with the protocol
研究组 & 干预措施
SOF+RBV 16 Weeks
SOF+RBV for 16 weeks
干预措施: SOF (Drug)
SOF+RBV 16 Weeks
SOF+RBV for 16 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)
结局指标
主要结局
Incidence of Adverse Events Leading to Permanent Discontinuation of Study Drug(s)
时间窗: Up to 24 weeks
The percentage of participants permanently discontinuing any study drug due to an adverse event was summarized.
Percentage of Participants With Sustained Virologic Response (SVR) at 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.
次要结局
- Percentage of Participants With Sustained Virologic Response at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)(Posttreatment Weeks 4 and 24)
- Percentage of Participants Experiencing On-treatment Virologic Failure(Up to 24 weeks)
- Percentage of Participants Experiencing Virologic Relapse(Up to Posttreatment Week 12)