A Phase 3, Multicenter, Open-Label Study to Investigate the Efficacy and Safety of GS-7977 With Peginterferon Alfa 2a and Ribavirin for 12 Weeks in Treatment-Naive Subjects With Chronic Genotype 1, 4, 5, or 6 HCV Infection
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 328
- 试验地点
- 55
- 主要终点
- Percentage of Participants Achieving Sustained Virologic Response (SVR)12
研究概览
简要总结
This study was to assess whether sofosbuvir in combination with ribavirin (RBV) and pegylated interferon alfa 2a (PEG) administered for 12 weeks is safe and effective in patients with hepatitis C virus (HCV) genotypes 1, 4, 5 , or 6 as assessed by the rate of sustained viral response (SVR) 12 weeks after discontinuation of therapy (SVR12).
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 HCV genotype 1, 4, 5, or 6
- •Cirrhosis determination
- •Subject met the following classifications:
- •Treatment-naive
- •Screening laboratory values within defined thresholds
- •Not treated with any investigational drug or device within 30 days of screening
- •Use of highly effective contraception methods if female of childbearing potential or sexually active male
排除标准
- •Prior exposure to an direct-acting antiviral targeting the HCV nonstructural protein (NS)5B 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 have interfered with subject treatment, assessment, or compliance with the protocol
- •Excessive alcohol ingestion or significant drug abuse
研究组 & 干预措施
Sofosbuvir+PEG+RBV
干预措施: Sofosbuvir (Drug)
Sofosbuvir+PEG+RBV
干预措施: RBV (Drug)
Sofosbuvir+PEG+RBV
干预措施: PEG (Drug)
结局指标
主要结局
Percentage of Participants Achieving Sustained Virologic Response (SVR)12
时间窗: Posttreatment Week 12
SVR12 was defined as HCV RNA \< the lower limit of quantitation (LLOQ; ie, 25 IU/mL) 12 weeks after cessation of therapy.
Number of Participants Experiencing Adverse Events Leading to Permanent Discontinuation of Study Drug
时间窗: Baseline to Week 12
The number of participants experiencing adverse events leading to permanent discontinuation of study drug was summarized. Adverse events may or may not have been related to study treatment. Participants discontinuing study drug were permitted to remain on the study for further assessments.
次要结局
- Percentage of Participants With Viral Breakthrough(Baseline to Week 12)
- Percentage of Participants With Viral Relapse(End of treatment to post-treatment Week 24)
- Percentage of Participants Achieving SVR4(Posttreatment Week 4)
- Percentage of Participants Achieving SVR24(Posttreatment Week 24)