Serious respiratory syncytial virus (RSV) disease in children with hemodynamically significant congential heart disease (CHD). MedDRA version: 9.0 Level: PT Classification code 10061603 Term:
Conditions
Interventions
Product Name: Motavizumab
Product Code: MEDI-524
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Motavizumab
CAS Number
Sponsors
MedImmune, LLC
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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 pulmonary artery (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(s). 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
Exclusion criteria
Exclusion criteria: 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 illness, 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 any polyclonal antibody (for example, Hepatitis B IG, IVIG, VZIG) within 3 months prior to randomization. 12. Receipt of palivizumab (Synagis®) within 3 months prior to randomization. 13. 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). 14. Current participation in other investigational protocols of drugs or biological agents. 15. Previous participation in MI-CP124 (Season 1).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective is to describe the safety and tolerability of motavizumab when given monthly as prophylaxis against serious RSV infection among children with hemodynamically significant CHD.; Secondary Objective: The secondary objectives of this study are: 1. To describe the incidence of RSV hospitalization in children with hemodynamically significant CHD given motavizumab or palivizumab for prophylaxis against serious RSV disease. 2. To describe the incidence of RSV-specific, medically-attended outpatient lower respiratory infections (LRI) in each treatment group. 3. To describe the pharmacokinetics and immunogenicity of motavizumab. 4. To describe the effect of cardiopulmonary bypass on serum motavizumab concentrations. ;Primary end point(s): Safety and tolerability of MEDI-524 will be assessed primarily by summarizing adverse events occurring through Study Day 150, including the occurrence of increased toxicity grade from baseline as determined in laboratory evaluations. Adverse and serious adverse events will be summarized by system organ class and preferred term, by severity, and by relationship to study drug. | — |
Countries
Austria, Belgium, Czech Republic, France, Germany, Hungary, Poland, Sweden, United Kingdom
Outcome results
None listed