A Phase 3b, Multi-Center, Randomized, Open-Label, Study to Evaluate the Safety and Efficacy of Sofosbuvir Plus Ribavirin in Treatment-Naïve Adults With Chronic Genotype 1 or 3 Hepatitis C Virus Infection
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 117
- 主要终点
- Percentage of Participants With Sustained Virologic Response 12 Weeks After Discontinuation of Therapy (SVR12)
研究概览
简要总结
This study will evaluate the antiviral efficacy, safety, and tolerability of sofosbuvir (SOF) + ribavirin (RBV) in treatment-naive adults with chronic genotype 1 or 3 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
- •HCV RNA ≥10^4 IU/mL at screening
- •Confirmed chronic HCV genotype 1 or 3 infection
- •HCV treatment naive
- •Approximately 30% of individuals may have compensated cirrhosis at screening
排除标准
- •Any other chronic liver disease
- •Infection with hepatitis B virus (HBV) or human immunodeficiency virus (HIV)
- •Current or prior history of clinical hepatic de-compensation
- •Contraindication to RBV therapy, e.g., history of clinically significant hemoglobinopathy (sickle cell disease, thalassemia).
- •Chronic use of systemically administered immunosuppressive agents
- •History of solid organ transplantation
研究组 & 干预措施
Sofosbuvir+RBV 16 weeks
Participants with HCV genotypes 1 and 3 will receive sofosbuvir plus ribavirin for 16 weeks.
干预措施: Sofosbuvir (Drug)
Sofosbuvir+RBV 16 weeks
Participants with HCV genotypes 1 and 3 will receive sofosbuvir plus ribavirin for 16 weeks.
干预措施: RBV (Drug)
Sofosbuvir+RBV 24 weeks
Participants with HCV genotypes 1 and 3 will receive sofosbuvir plus ribavirin for 24 weeks.
干预措施: Sofosbuvir (Drug)
Sofosbuvir+RBV 24 weeks
Participants with HCV genotypes 1 and 3 will receive sofosbuvir plus ribavirin for 24 weeks.
干预措施: RBV (Drug)
结局指标
主要结局
Percentage of Participants With Sustained Virologic Response 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.
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 Sustained Virologic Response (SVR) at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)(Posttreatment Weeks 4 and 24)
- Percentage of Participants With Virologic Failure and Viral Relapse(Up to Posttreatment Week 24)