NCT00979251已完成2 期
A Randomized Open Label Study Comparing the Efficacy, Safety, and Tolerability of Oral Administration of Amantadine and Ribavirin With Oseltamivir Versus Oseltamivir to Influenza A Virus Infected Immunocompromised Subjects
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 2
- 试验地点
- 2
- 主要终点
- Time to clearing of viral shedding
研究概览
简要总结
This Phase 2, open label, randomized study will investigate the virologic benefit, clinical efficacy, safety, and tolerability of amantadine and ribavirin with oseltamivir (TCAD) versus oseltamivir monotherapy for the treatment of all strains of influenza A in immunocompromised adult and pediatric subjects.
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
- 1 Year 至 65 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Confirmed influenza A by rapid antigen testing
- •Immunocompromised as defined by recent solid organ or hematopoietic transplant, chronic graft vs. host disease, taking at least 2 immunosuppressants, undergoing chemotherapy, taking high dose chemotherapeutics, HIV positive
- •Clinical diagnosis of influenza
- •Onset of illness within 5 days
- •Male and female subjects agree to contraception through 24 weeks after last dose
排除标准
- •Received more than 1 dose of antiviral agents
- •Critically ill
- •Creatinine clearance less than 80 mg/mL
- •Females who are pregnant and males whose female partners are pregnant
- •Received live attenuated virus vaccine within 3 weeks
研究组 & 干预措施
ADS-8902
Experimental
Amantadine and Ribavirin administered with Oseltamivir phosphate
干预措施: ADS-8902 (Drug)
Comparator
Active Comparator
Oseltamivir Phosphate
干预措施: Oseltamivir Phosphate (Drug)
结局指标
主要结局
Time to clearing of viral shedding
时间窗: Baseline, Days 2, 4, 6, 8, 10, 15 and 20
次要结局
- Time to alleviation of influenza clinical symptoms(Baseline, Days 2, 4, 6, 8, 10, 15, 20, 38)
- Proportion of subjects who enter the study with mild to moderate influenza and progress to severe influenza(Baseline, Days 2, 4, 6, 8, 10, 15, 20, 38)
- Proportion of subjects with a treatment-sensitive influenza A strain at baseline who develop a resistant strain during treatment(Baseline, Days 2, 4, 6, 8, 10, 15, 20)
- Safety and tolerability (adverse events (AEs), AEs resulting in treatment discontinuation, and Serious AEs)(Through day 210)
研究者
研究点 (2)
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