A Phase 2, Open-Label Study of Sofosbuvir in Combination With PEG and Ribavirin for 12 Weeks in Treatment Experienced Subjects With Chronic HCV Infection Genotype 2 or 3
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 47
- 试验地点
- 1
- 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 is to evaluate the safety, tolerability, and antiviral efficacy of sofosbuvir (SOF) in combination with peginterferon alfa 2a (PEG) and ribavirin (RBV) administered for 12 weeks in participants with chronic genotype 2 or 3 hepatitis C virus (HCV) infection who have previously failed prior treatment with an interferon-based regimen.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Infection with genotype 2 or 3 HCV infection
- •Cirrhosis determination
- •Individual is treatment-experienced
- •Screening laboratory values within defined thresholds
- •Individual has not been treated with any investigational drug or device within 30 days of the Screening visit
- •Use of highly effective contraception methods if female of childbearing potential or sexually active male
排除标准
- •Prior exposure to a direct-acting antiviral drug targeting the HCV NS5B polymerase
- •Pregnant or nursing female or male with pregnant female partner
- •Current or prior history of clinical hepatic decompensation
- •History of clinically-significant illness or any other major medical disorder that may interfere with treatment, assessment, or compliance with the study protocol
- •Excessive alcohol ingestion or significant drug abuse
研究组 & 干预措施
SOF+PEG+RBV
Participants will receive SOF+PEG+RBV for 12 weeks.
干预措施: SOF (Drug)
SOF+PEG+RBV
Participants will receive SOF+PEG+RBV for 12 weeks.
干预措施: PEG (Drug)
SOF+PEG+RBV
Participants will receive SOF+PEG+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, \< 15 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 discontinuing any study drug due to an adverse event was summarized.
次要结局
- 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)
- Percentage of Participants Experiencing On-treatment Virologic Failure(Up to 12 weeks)