Dettagli per singolo studio

DEC-NET Serial number FR529

Published online	02/03/2006 22.56.00
Last updated	04/12/2006 11.06.26

Other protocol ID number	MI-CP124
Current trial status	Open (actively recruiting new participants)
Major Disease (ICD9 class)	Other congenital anomalies of heart
Experimental drug
Humanized IgG1 monoclonal antibody Treatment regimen (dosage and duration) 15 mg/kg administered IM every 30 days for a total of 5 injections
Control drug
Palivizumab Treatment regimen (dosage and duration) 15 mg/kg administered IM every 30 days for a total of 5 injections
Gender	Both
Age (range)	< or equal 24 months
Eligibility criteria
Inclusion criteria
-Children 24 months or younger at randomisation (child must be 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) or legal guardian.
Exclusion criteria
None of the following criteria: -Unstable cardiac or respiratory status: including severe cardiac defects, cardiac transplantation -Hospitalization, unless discharge is 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 or ather acute infection or illness -Chronic seizure or evolving or unstable neurologic disorder -Known immunodeficiency -Mother with HIV infection -Known allergy to Ig products -Receipt of palivizumab, RSV-IGIV, or other RSV-specific monoclonal antibody, or any other polyclonal antibody -Use of investigational agents within the past three months -Current particiaption in other investigational protocols of drugs
Trial design/methodology
Phase	3
Kind of study	Prophylaxis Safety Pharmacokinetics
Design	Controlled Randomised Blinded Double blind
Purpose of study
Primary objective: -To describe the safety and tolerability of MEDI-524 when given monthly as prophylaxis against serious RSV infection among children with hemodynamically significant congenital heart disease (CHD). Secondary objectives: -To determine the pharmacokinetics and immunogenicity of MEDI-524 -To quantify the RSV hospitalisation rates in children with hemodynamically significant CHD given MEDI-524 or palivizumab for prophylaxis against serious RSV disease. -To describe the effect of cardiac bypass on serum MEDI-524 concentrations
Primary outcomes
-All serious adverse events occurring through study day 150
Secondary outcomes
-MEDI-524 plasma concentrations -Number and percentages of children who develop detectable anti-MEDI-524 antibodies. -Incidence of RSV hospitalization from study day 0 through day 150 -Primary and nosocomial hospitalizations -Deaths caused by RSV
Summary of study design, objectives, and ongoing research findings
Study MI-CP124 is a randomized, double-blinded, palivizumab-controlled, multicenter, multi-national trial conducted during the RSV season. Safety and tolerability of MEDI-524 are evaluated(IgG1 monoclonal antibody) when given monthly as prophylaxis against serious RSV infection among children with hemodynamically significant CHD. Approximately 600 children with hemodynamically significant cardiac heart disease are randomized to receive either 15 mg/kg MEDI-524 or 15 mg/kg palivizumab by IM injection every 30 days. Safety and tolerability of MEDI-524 are assessed primarily by adverse events occuring through study.