A Phase 2, Randomized, Open-Label Study to Evaluate the Safety and Efficacy of Sofosbuvir Plus Ribavirin Administered for Either 12 or 24 Weeks in Treatment-Naive and Treatment-Experienced Egyptian Adults With Chronic Genotype 4 HCV Infection
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 60
- 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 is to evaluate the safety, tolerability, and antiviral activity of sofosbuvir (SOF) with ribavirin (RBV) in Egyptian adults with chronic genotype 4 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
- •First generation Egyptian; must have been born in Egypt and can trace both maternal and paternal Egyptian ancestry
- •Treatment-experienced or treatment-naive
- •Chronic genotype 4 HCV infection
- •Not co-infected with HIV
- •Screening laboratory values within defined thresholds
- •Use of highly effective contraception methods
- •Must be able to comply with the dosing instructions for study drug administration and able to complete the study schedule of assessments
排除标准
- •History of any other clinically significant chronic liver disease
- •Pregnant or nursing female or male with pregnant female partner
- •History of clinically-significant illness or any other major medical disorder that may interfere with treatment, assessment, or compliance with the protocol
- •Excessive alcohol ingestion or significant drug abuse
研究组 & 干预措施
SOF+RBV 12 Weeks
Treatment-naive and treatment-experienced participants will receive SOF+RBV for 12 weeks.
干预措施: SOF (Drug)
SOF+RBV 12 Weeks
Treatment-naive and treatment-experienced participants will receive SOF+RBV for 12 weeks.
干预措施: RBV (Drug)
SOF+RBV 24 Weeks
Treatment-naive and treatment-experienced participants will receive SOF+RBV for 24 weeks.
干预措施: SOF (Drug)
SOF+RBV 24 Weeks
Treatment-naive and treatment-experienced participants will receive 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 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 Experiencing On-treatment Virologic Failure(Up to 24 weeks)
- Percentage of Participants Experiencing Viral Relapse(Up to Posttreatment Week 24)
- Percentage of Participants With Sustained Virologic Response at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)(Posttreatment Weeks 4 and 24)