NCT00240929已完成2 期
A Phase II Randomized, Double-Blind, Two-Period Cross-Over Study to Evaluate the Pharmacokinetics, Safety and Tolerability of a Liquid Formulation of Palizvizumab (MEDI-493, Synagis), A Humanized Respiratory Syncytial Virus Monoclonal Antibody, in Children With a History of Prematurity
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- adverse events through 30 days after each injection of study drug and will have blood collected for determination of palivizumab concentrations in serum.
研究概览
简要总结
A total of 150 children who meet the entry criteria will be randomized 1:1 to receive one of the following treatment sequence A or B.
详细描述
Phase II, Double-blind, two-period, cross-over study to be conducted at 20 sites the U.S. A total of 150 children who meet the entry criteria will be randomized 1:1 to receive one of the following treatment sequence: Sequence A (single dose of the liquid formulation on Study Day 0 and a single dose of the lyophilized formulation on Study Day 30) or Sequence B (single dose of the lyophized forumation on Study Day 0 and single dose of the liquid formulation on Study Day 30). Children will be followed for adverse events through 30 days after each injection of study drug and will have blood collected for determination of palivizumab concentrations in serum.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 5 Months 至 6 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The child must have been born at greater than or equal to 35 weeks gestation and be greater than or equal to 6 months of age at the time of randomization (child must be randomized on or before their 6-month birthday)
- •The child's parent or legal guardian must provide written informed consent; and
- •The child must be able to complete the follow-up visits on Study Days 30 and 60 within the protocol specified windows (±2 days)
- •Parent/legal guardian of patient has available telephone access.
排除标准
- •Be hospitalized;
- •Birth hospitalization > 6 weeks duration;
- •Be receiving mechanical ventilation at the time of study entry (including CPAP);
- •Bronchopulmonary dysplasia (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.)
- •Known renal impairment, hepatic dysfunction, chronic seizure disorder, or immunodeficiency;
- •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 <9.0 gm/dL
- •white blood cell count <4,000 cells/mm3
- •platelet count <110,000 cells/mm3
- •Acute illness or progressive clinical disorder;
- •History of recent difficult venous access;
- •Active infection, including acute RSV infection;
- •Previous reaction to IGIV, blood products, or other foreign proteins;
- •Received within the past 120 days or currently receiving IGIV, other immunoglobulin products, or any investigational agents;
- •Have ever received palivizumab;
- •Currently participating in any investigational study; or
- •Previously participated in any investigational study of RSV vaccines or monoclonal antibodies.
结局指标
主要结局
adverse events through 30 days after each injection of study drug and will have blood collected for determination of palivizumab concentrations in serum.
时间窗: Day 30
次要结局
- Adverse events and serious adverse events for 30 days after each injection of study drug.(Day 30)
研究者
研究点 (2)
Loading locations...
相似试验
撤回
2 期
Efficacy and Safety Study of R935788 Tablets to Treat Systemic Lupus ErythematosusSystemic Lupus ErythematosusNCT00752999Rigel Pharmaceuticals
进行中（未招募）
1 期
A 15-WEEK CLINICAL STUDY TO DETERMINE THEEFFECTIVENESS, SAFETY AND TOLERABILITY OF PF-06649751 IN PATIENTS WITH MOTOR FLUCTUATIONS DUE TO PARKINSON’S DISEASEParkinson's DiseaseEUCTR2015-004912-39-DEPfizer, Inc.198
进行中（未招募）
1 期
A 15-WEEK CLINICAL STUDY TO DETERMINE THEEFFECTIVENESS, SAFETY AND TOLERABILITY OF PF-06649751 IN PATIENTS WITH MOTOR FLUCTUATIONS DUE TO PARKINSON'S DISEASEMedDRA version: 19.0Level: PTClassification code 10061536Term: Parkinson's diseaseSystem Organ Class: 10029205 - Nervous system disordersParkinson's DiseaseEUCTR2015-004912-39-ESPfizer, Inc.198
进行中（未招募）
1 期
A 15-WEEK CLINICAL STUDY TO DETERMINE THE EFFECTIVENESS, SAFETY AND TOLERABILITY OF PF-06649751 IN PATIENTS WITH EARLY PARKINSON’S DISEASEMedDRA version: 19.1Level: PTClassification code 10061536Term: Parkinson's diseaseSystem Organ Class: 10029205 - Nervous system disordersParkinson's DiseaseEUCTR2016-001575-71-ESPfizer, Inc.88
进行中（未招募）
1 期
A 15-WEEK CLINICAL STUDY TO DETERMINE THE EFFECTIVENESS, SAFETY AND TOLERABILITY OF PF-06649751 IN PATIENTS WITH EARLY PARKINSON’S DISEASEParkinson's DiseaseEUCTR2016-001575-71-DEPfizer, Inc.88