NCT00192478已完成1 期
A Phase 1/2, Open-Label, Repeat-Dose, Dose-Escalation Study to Evaluate the Safety, Tolerability, Immunogenicity, and Pharmacokinetics of MEDI-524, a Humanized Enhanced Potency Monoclonal Antibody Against Respiratory Syncytial Virus (RSV), in Children at Risk for Serious RSV Disease
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 217
- 试验地点
- 5
- 主要终点
- Describe the safety and tolerability of repeated IM doses of MEDI-524 administered at 3 mg/kg or 15 mg/kg at 30 day intervals in children at risk for serious RSV disease
研究概览
简要总结
MEDI-524 given for up to 5 doses at 3 and 15 mg/kg to high-risk children appeared to be safe and well tolerated.
详细描述
This study is designed to describe the safety, tolerability, immunogenicity, and pharmacokinetics of escalating, repeated IM injections (the intended route of administration for immunoprophylaxis) of MEDI-524, initially in children £6 months old with a history of prematurity (³32 to £35 weeks gestation, without BPD), one of the target populations of infants at high risk for serious RSV disease.
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
- 6 Months 至 24 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All male or female children must have met all the following criteria:
- •[Groups 1, 2, and 3] The child must have been born at ³32 to £35 weeks gestation and have been £6 months of age at the time of entry into the study (child must have been entered on or before their 6-month birthday) or [Group 3 only] The child must have been £24 months of age at the time of entry into the study (child must have been entered on or before their 24-month birthday) and diagnosed with BPD, with stable or decreasing doses of diuretics, steroids, or bronchodilators within the previous 6 months
- •The child must have been in general good health at the time of entry
- •The child's parent or legal guardian must have provided written informed consent; and
- •The child must have been able to complete the follow-up visits through 90 days following last injection of MEDI-524
- •Parent/legal guardian of patient must have had available telephone access
排除标准
- •Children must have had none of the following:
- •Hospitalization at the time of study entry (unless discharge was expected within 3 days after entry into the study)
- •[All children in Groups 1 and 2; only children £6 months of age in Group 3] Birth hospitalization >6 weeks duration or [Only children >6 months of age in Group 3] Birth hospitalization >12 weeks duration
- •Been receiving chronic oxygen therapy or mechanical ventilation at the time of study entry (including CPAP)
- •[Groups 1 and 2 only] Diagnosis of BPD, defined as history of prematurity and associated chronic lung disease with oxygen requirement for >28 days
- •Congenital heart disease (CHD) (Children with medically or surgically corrected [closed] patent ductus arteriosus and no other CHD may be enrolled)
- •Evidence of infection with hepatitis A, B, or C virus
- •Known renal impairment, hepatic dysfunction, chronic seizure disorder, or immunodeficiency or HIV infection
- •Mother with known HIV infection
- •Any of the following laboratory findings in blood obtained within 7 days prior to study entry: BUN or creatinine >1.5´ the upper limit of normal for age; AST (SGOT) or ALT (SGPT) >1.5´ the upper limit of normal for age; hemoglobin <9.5 gm/dL; white blood cell count <4,000 cells/mm3; platelet count <120,000 cells/mm3
- •Acute illness or progressive clinical disorder
- •Active infection, including acute RSV infection
- •Previous reaction to IGIV, blood products, or other foreign proteins
- •Have ever received palivizumab
- •Received within the past 120 days or currently receiving immunoglobulin products (such as RSV-IGIV [RespiGamÒ], IVIG), or any investigational agents
- •Currently participating in any investigational study
- •Previously participated in any investigational study of RSV vaccines or monoclonal antibodies.
结局指标
主要结局
Describe the safety and tolerability of repeated IM doses of MEDI-524 administered at 3 mg/kg or 15 mg/kg at 30 day intervals in children at risk for serious RSV disease
时间窗: 30 days after patient's final dose of study drug
Pharmacokinetics of MEDI-524
时间窗: · Serum concentrations at each data collection visit will be summarized
次要结局
- Immunogenicity of MEDI-524(· Serum ELISA binding activity at each data collection visit will be summarized)
研究者
研究点 (5)
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