A Phase 3b, Multicenter, Open-Label Study to Investigate the Efficacy and Safety of Sofosbuvir Plus Ribavirin in Treatment-Naïve and Treatment-Experienced Japanese Subjects With Chronic Genotype 2 HCV Infection
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 153
- 主要终点
- Percentage of Participants With Sustained Virologic Response (SVR) at 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) plus ribavirin (RBV) in Japanese participants with chronic genotype 2 hepatitis C virus (HCV) infection.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Chronic genotype 2 HCV-infection
- •Male or female, age ≥ 20 years
- •Body weight ≥ 40 kg
- •HCV RNA ≥ 10,000 IU/mL at screening
排除标准
- •Current or prior history of clinically significant illness other than HCV
- •Pregnant or nursing female or male with pregnant female partner
- •Chronic liver disease of a non-HCV etiology
- •Infection with hepatitis B virus (HBV) or human immunodeficiency virus (HIV)
研究组 & 干预措施
Sofosbuvir+RBV 12 weeks
Participants will receive sofosbuvir+RBV for 12 weeks.
干预措施: Sofosbuvir (Drug)
Sofosbuvir+RBV 12 weeks
Participants will receive sofosbuvir+RBV for 12 weeks.
干预措施: RBV (Drug)
结局指标
主要结局
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.
Incidence of Adverse Events Leading to Permanent Discontinuation of Study Drug(s)
时间窗: Up to 12 weeks
The percentage of participants permanently discontinuing any study drug due to an adverse event was summarized.
次要结局
- Percentage of Participants Experiencing Viral Breakthrough(Up to 12 weeks)
- 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 Viral Relapse(Up to Posttreatment Week 24)