The ATOMIC Study: A Multicenter, Open-label, Randomized, Duration Finding Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Following Oral Administration of PSI-7977 in Combination With Pegylated Interferon and Ribavirin in Treatment-Naive Patients With Chronic HCV Infection Genotype 1,4, 5, or 6
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 332
- 试验地点
- 46
- 主要终点
- Percentage of Participants With Sustained Virologic Response 24 Weeks Following Completion of Treatment (SVR24)
研究概览
简要总结
The purpose of this study is to assess the safety, tolerability, and efficacy of sofosbuvir (GS-7977; PSI-7977) administered in combination with pegylated interferon and ribavirin (PEG/RBV) in treatment-naive patients with HCV genotypes 1,4,5,6, or indeterminate genotype.
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
- •Males and females with Chronic Hepatitis C (HCV) Genotype 1,4,5,6, or indeterminate
- •Naive to previous HCV treatment
排除标准
- •Positive for HBsAg, anti-HBc IgM Ab, or anti-HIV Ab
- •History of any other clinically significant chronic liver disease
研究组 & 干预措施
SOF+PEG+RBV 12 weeks
Participants were randomized to receive sofosbuvir+PEG+RBV for 12 weeks.
干预措施: Sofosbuvir (Drug)
SOF+PEG+RBV 12 weeks
Participants were randomized to receive sofosbuvir+PEG+RBV for 12 weeks.
干预措施: PEG (Drug)
SOF+PEG+RBV 12 weeks
Participants were randomized to receive sofosbuvir+PEG+RBV for 12 weeks.
干预措施: RBV (Drug)
SOF+PEG+RBV 24 weeks
Participants were randomized to receive sofosbuvir+PEG+RBV for 24 weeks.
干预措施: RBV (Drug)
SOF+PEG+RBV 24 weeks
Participants were randomized to receive sofosbuvir+PEG+RBV for 24 weeks.
干预措施: Sofosbuvir (Drug)
SOF+PEG+RBV 24 weeks
Participants were randomized to receive sofosbuvir+PEG+RBV for 24 weeks.
干预措施: PEG (Drug)
SOF+PEG+RBV 12 week/Rerandomization Group
Participants were randomized to receive sofosbuvir+PEG+RBV for 12 weeks, then were rerandomized to receive sofosbuvir only or sofosbuvir+RBV for 12 additional weeks.
干预措施: Sofosbuvir (Drug)
SOF+PEG+RBV 12 week/Rerandomization Group
Participants were randomized to receive sofosbuvir+PEG+RBV for 12 weeks, then were rerandomized to receive sofosbuvir only or sofosbuvir+RBV for 12 additional weeks.
干预措施: PEG (Drug)
SOF+PEG+RBV 12 week/Rerandomization Group
Participants were randomized to receive sofosbuvir+PEG+RBV for 12 weeks, then were rerandomized to receive sofosbuvir only or sofosbuvir+RBV for 12 additional weeks.
干预措施: RBV (Drug)
结局指标
主要结局
Percentage of Participants With Sustained Virologic Response 24 Weeks Following Completion of Treatment (SVR24)
时间窗: Post-treatment Week 24
SVR24 was defined as HCV RNA \< the limit of detection (LOD; \< 15 IU/mL) 24 weeks after the last dose of study drug.
Percentage of Participants Who Experienced Adverse Events
时间窗: Baseline (Day 1) to post-treatment Day 30
Adverse events (AEs) occurring from baseline (Day 1 for all groups) to 30 days following the last dose of study drug were summarized across the participant population. A participant was counted once if they had a qualifying event.
次要结局
- Percentage of Participants With Sustained Virologic Response 12 Weeks Following Completion of Treatment (SVR12)(Post-treatment Week 12)
- Change in HCV RNA at Week 2(Baseline (Day 1) to Week 2)
- Change in HCV RNA at Week 4(Baseline (Day 1) to Week 4)
- Change in HCV RNA at Week 8(Baseline (Day 1) to Week 8)
- Change in HCV RNA at Week 12(Baseline (Day 1) to Week 12)
- Percentage of Participants With HCV RNA < LOD at Week 2(Week 2)
- Percentage of Participants With HCV RNA Below < LOD at Week 4(Week 4)
- Percentage of Participants With HCV RNA Below < LOD at Week 8(Week 8)
- Percentage of Participants With HCV RNA Below < LOD at Week 12(Week 12)
- Percentage of Participants With HCV RNA Below < LOD at Week 24(Week 24)
- Percentage of Participants With ALT Normalization at Week 12(Baseline (Day 1) to Week 12)
- Percentage of Participants With ALT Normalization at Week 24(Baseline (Day 1) to Week 24)
- Percentage of Participants With ALT Normalization at Post-treatment Week 4(Baseline (Day 1) to Post-treatment Week 4)
- Percentage of Participants With Virologic Failure During Treatment(Baseline (Day 1) to Week 24)
- Percentage of Participants With Virologic Failure Following Treatment (Viral Relapse).(End of treatment to Post-treatment Week 24)