NCT02635724已完成3 期
A Phase 3, Multicenter, Single-arm, Open-label, Study to Evaluate the Safety, Pharmacokinetics and Effectiveness of Intravenous Peramivir in Elderly Subjects With Acute Uncomplicated Influenza Infection and in Subjects With Acute Uncomplicated Influenza Infection at Higher Risk for Influenza Complications
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 74
- 试验地点
- 3
- 主要终点
- Safety and Tolerability, as Measured by the Number of Adverse Events.
研究概览
简要总结
This study will evaluate the safety, pharmacokinetics and effectiveness of a single dose of 600 mg IV peramivir in the treatment of elderly subjects with acute uncomplicated influenza infection and in subjects with acute uncomplicated influenza infection at higher risk for influenza complications. All subjects will receive IV peramivir.
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
- •A positive influenza Rapid Antigen Test (RAT) and/or a FDA-approved PCR test and at least one clinical sign or symptom consistent with acute influenza infection as listed below OR
- •Clinical signs and symptoms consistent with acute influenza infection consisting of an oral temperature ≥ 100°F (37.8°C) with at least one respiratory symptom of at least moderate severity (cough or rhinitis) and at least one constitutional symptom of at least moderate severity (myalgia [aches and pains], headache, feverishness, or fatigue)
- •Influenza symptom onset < 48 hours. However, due to historically delayed presentation for medical care in the adult population, approximately 20% of the elderly population may be enrolled with symptoms starting > 48-hours but ≤ 72-hours
排除标准
- •Women who plan to breast-feed for the first 48 hours after study drug administration
- •Subjects requiring hospital admission to treat medical condition(s) which could represent complications of influenza.
- •Recent worsening of any chronic medical condition consistent with complications of influenza
- •Current evidence of a bacterial infection requiring antibiotic treatment
研究组 & 干预措施
Peramivir
Experimental
Single dose 600 mg IV injection
干预措施: Peramivir (Drug)
结局指标
主要结局
Safety and Tolerability, as Measured by the Number of Adverse Events.
时间窗: 14 days
Safety was evaluated through assessment of Adverse Events (AEs).
次要结局
- Time to Reduction in Viral Shedding(14 days)
- Plasma Exposure of IV Peramivir as Measured by Drug Concentrations up to 3 Hours Post Infusion(up to 3 hours post peramivir infusion)
- Changes in Influenza Virus Titer in Nasopharyngeal Samples in Response to Treatment.(Change from baseline assessed on days 3, 7 and 14.)
- Time to Resolution of Fever(14 days)
- Time to Resolution of Influenza Symptoms(14 days)
- Incidence of Influenza-related Complications(14 days)
- Time to Return to Usual Activities(14 days)
研究者
研究点 (3)
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