EUCTR2005-001671-35-CZ进行中（未招募）不适用
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
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 1,400
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Children must meet all of the following criteria:
- •1. 24 months of age or younger at randomization (child must be randomized on or before their 24-month birthday)
- •2. Documented, hemodynamically significant CHD. Note: The following children are 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 PA) or the need for daily medication to manage CHD.
- •3. Unoperated or partially corrected CHD
- •4. Written informed consent obtained from the patient’s parent(s)/legal guardian
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Children must have none of the following:
- •1. Unstable cardiac or respiratory status, including cardiac defects so severe that survival is not expected or for which cardiac transplantation is planned or anticipated
- •2. Hospitalization, unless discharge is anticipated within 21 days
- •3. Anticipated cardiac surgery within two weeks of randomization
- •4. Requirement for mechanical ventilation, extracorporeal membrane oxygenation, continuous positive airway pressure or other mechanical respiratory or cardiac support
- •5. Associated non-cardiac anomalies or end organ dysfunction resulting in anticipated survival of less than six months or unstable abnormalities of end organ function
- •6. Acute respiratory or other acute infection or illness. Note: children with any respiratory symptoms must have a negative RSV test prior to randomization
- •7. Chronic seizure or evolving or unstable neurologic disorder
- •8. Known immunodeficiency
- •9. Mother with HIV infection (unless the child has been proven to be not infected)
- •10. Known allergy to Ig products
- •11. Receipt of palivizumab, RSV-IGIV, or other RSV-specific monoclonal antibody, or any other polyclonal antibody (for example, Hepatitis B IG, IVIG, VZIG) within 3 months prior to randomization
- •12. 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)
- •13. Current participation in other investigational protocols of drugs or biological agents
研究者
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