NCT02369159已完成3 期
A Phase 3, Randomized, Open Label, Active-controlled Study to Evaluate the Safety, Pharmacokinetics and Effectiveness of IV Peramivir Compared to Oral Oseltamivir in Pediatric Subjects With Acute Uncomplicated Influenza
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
- 137
- 试验地点
- 2
- 主要终点
- Safety and Tolerability, as Measured by the Number of Participants Experiencing Adverse Events.
研究概览
简要总结
This study will evaluate the safety, pharmacokinetics and effectiveness of a single dose of IV peramivir compared to a standard 5 day course of oral oseltamivir in the treatment of pediatric subjects with acute uncomplicated influenza.
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
- 0 Days 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical signs and symptoms consistent with acute influenza infection consisting of an oral temperature ≥ 100°F (37.8°C) or rectal temperature ≥ 101.3ºF (≥ 38.5ºC) with at least one respiratory symptom (cough or rhinitis) OR Positive influenza determined by PCR or Rapid Antigen Test
- •Onset of symptoms no more than 72 hours before presentation for screening for subjects < 2 years old.
排除标准
- •Pregnant or breast-feeding females
- •Development of symptoms while hospitalized
- •Presence of a chronic disease or illness that may indicate increased risk for influenza-related complications
- •Presence of immunocompromised status
研究组 & 干预措施
Peramivir (IV)
Experimental
Subjects randomized to peramivir will receive an age appropriate single dose, diluted to a maximum volume of 100 mL in normal saline, administered as a short intravenous infusion over a minimum of 15 minutes.
- Subjects ≥12 years will receive a dose of 600 mg.
- Subjects <12 years will receive a dose of 12 mg/kg (to a maximum dose of 600 mg).
- Subjects < 6 months will receive a dose of 8 mg/kg.
干预措施: Peramivir (Drug)
Oseltamivir
Active Comparator
Subjects randomized to oral oseltamivir will receive an age appropriate dose twice daily for 5 days.
- Subjects ≥ 13 years will receive a 75mg dose administered as a capsule or oral suspension (twice daily for 5 days).
- Subjects < 13 years of age will receive a weight-based dose administered as a capsule or oral suspension (twice daily for 5 days).
干预措施: Oseltamivir (Drug)
结局指标
主要结局
Safety and Tolerability, as Measured by the Number of Participants Experiencing Adverse Events.
时间窗: 14 days
Safety evaluation included assessment of Adverse Events (AEs).
次要结局
- Time to Reduction in Viral Shedding(14 days)
- Influenza-Related Complications Assessment.(14 days)
- Plasma Exposure of IV Peramivir as Measured by the Drug Concentration Over 6 Hours Post-dose(up to 6 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)
研究者
研究点 (2)
Loading locations...
相似试验
撤回
3 期
A Study to Evaluate the Efficacy and Safety of Intravenous Peramivir in Subjects With Uncomplicated Influenza.InfluenzaNCT01224795BioCryst Pharmaceuticals1
已完成
3 期
A Study of Letermovir (MK-8228) to Evaluate Efficacy and Safety for Prevention of Cytomegalovirus Infection in Chinese Hematopoietic Stem Cell Transplant Recipients (MK-8228-045)Cytomegalovirus InfectionNCT05763823Merck Sharp & Dohme LLC120
已完成
1 期
A Clinical Trial to Evaluate the Pharmacokinetics and Safety/Tolerability of Fimasartan and Linagliptin in Healthy VolunteersDiabetesHypertensionNCT03609294Boryung Pharmaceutical Co., Ltd67
已完成
3 期
Safety and Efficacy of Paricalcitol Capsules in Decreasing Serum Parathyroid Hormone Levels in Children Aged 10-16 With Chronic Kidney Disease (CKD)Chronic Kidney Disease Stage 3 and 4NCT01020487AbbVie (prior sponsor, Abbott)47
已完成
1 期
Study to Assess the Safety and PK of Oral and IV Xenleta in Adults With Cystic FibrosisCystic FibrosisNCT05225805Nabriva Therapeutics AG13