A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of MEDI-524, a Humanized Enhanced Potency Monoclonal Antibody Against Respiratory Syncytial Virus (RSV), in Children With Hemodynamically Significant Congenital Heart Disease
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 1,236
- 试验地点
- 284
- 主要终点
- Number of Subjects Reporting Adverse Events Through Study Day 150
研究概览
简要总结
The primary goal was to describe the safety of the investigational product when given monthly to prevent serious respiratory infection among children with significant heart disease.
详细描述
The primary objective was to describe the safety and tolerability of motavizumab when given monthly as prophylaxis against serious RSV infection among children with hemodynamically significant congenital heart disease.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- — 至 24 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •24 months of age or younger at randomization (child must have been randomized on or before their 24-month birthday)
- •Documented, hemodynamically significant CHD
- •Unoperated or partially corrected CHD
- •Written informed consent obtained from the patient's parent(s)/legal guardian(s) Note: The following children were not eligible: children with uncomplicated small atrial or ventricular septal defects or patent ductus arteriosus, children with aortic stenosis, pulmonic stenosis, or coarctation of the aorta alone. Children with acyanotic cardiac lesions must have pulmonary hypertension [≥ 40 mmHg measured pressure in the pulmonary artery (PA)] or the need for daily medication to manage CHD.
排除标准
- •Unstable cardiac or respiratory status, including cardiac defects so severe that survival was not expected or for which cardiac transplantation was planned or anticipated
- •Hospitalization, unless discharge was anticipated within 21 days
- •Anticipated cardiac surgery within two weeks of randomization
- •Requirement for mechanical ventilation, extracorporeal membrane oxygenation, continuous positive airway pressure or other mechanical respiratory or cardiac support
- •Associated non-cardiac anomalies or end organ dysfunction resulting in anticipated survival of less than six months or unstable abnormalities of end organ function
- •Acute respiratory illness, or other acute infection or illness Note: children with any respiratory symptoms must have had a negative RSV test prior to randomization
- •Chronic seizure or evolving or unstable neurologic disorder
- •Known immunodeficiency
- •Mother with HIV infection (unless the child had been proven to be not infected)
- •Known allergy to Ig products
- •Receipt of any polyclonal antibody (for example, Hepatitis B IG, IVIG, VZIG) within 3 months prior to randomization
- •Receipt of palivizumab (Synagis®) within 3 months prior to randomization
- •Use of investigational agents within the past three months (other than investigational agents commonly used during cardiac surgery or the immediate post-operative period, e.g., nitric oxide)
- •Current participation in other investigational protocols of drugs or biological agents
- •Previous participation in MI-CP124 (Season 1)
结局指标
主要结局
Number of Subjects Reporting Adverse Events Through Study Day 150
时间窗: Days 0-150
Adverse events were summarized by system organ class (SOC) and preferred term (using MedDRA Version 11.1) overall.
Number of Subjects Reporting Serious Adverse Events Through Study Day 150
时间窗: Days 0-150
Serious adverse events were those that resulted in death; were life-threatening; resulted in subject hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability or incapacity; or were an important medical event that may not have resulted in death, threatened life, or required hospitalization and that, based on appropriate medical judgment, may have jeopardized the subject and may have required medical or surgical intervention to prevent one of the outcomes listed above.
Number of Subjects Reporting Laboratory Adverse Events
时间窗: Days 0-150
次要结局
- The Number of Subjects Hospitalized for RSV Infection.(Days 0-150)
- The Number of Subjects With RSV Outpatient MA-LRI for Season 2 Only.(Days 0-150)
- Number of Subjects Who Had Anti-motavizumab Antibodies Detected(Days 0-150)
- Mean Trough Serum Concentration of Motavizumab at Pre-dose 1(Pre-dose 1)
- Mean Trough Serum Concentration of Motavizumab at 30 Days Post-dose 1(30 days post-dose 1)
- Mean Trough Serum Concentration of Motavizumab at 30 Days Post-dose 2(30 days post-dose 2)
- Mean Trough Serum Concentration of Motavizumab at 30 Days Post-dose 3(30 days post-dose 3)
- Mean Trough Serum Concentration of Motavizumab at 30 Days Post-dose 4(30 days post-dose 4)
- Mean Trough Serum Concentrations of Motavizumab in Subjects Who Underwent Cardiac Surgery With Cardiopulmonary Bypass(Days 0-150)