A Study to Evaluate MEDI-524 In Children With Hemodynamically Significant Congenital Heart Disease - Full Text View

Sponsored by:	MedImmune LLC
Information provided by:	MedImmune LLC
ClinicalTrials.gov Identifier:	NCT00538785

Purpose

The primary goal is to describe the safety and tolerability of the vaccine when given monthly for serious respiratory infection among children with significant heart disease.

Condition	Intervention	Phase
Heart Disease	Biological: Motavizumab Biological: Palivizumab	Phase III

MedlinePlus related topics: Heart Diseases

Drug Information available for: Immunoglobulins Globulin, Immune MEDI-524 Palivizumab

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Single Group Assignment, Safety Study
Official Title:	A Study to Evaluate the Safety, Tolerability, Pharmacokinetics/Immunogenicity of MEDI-524, a Humanized Enhanced Potency Monoclonal Antibody Against Respiratory Syncytial Virus (RSV), in Children With Hemodynamically Significant Congenital Heart Disease

Further study details as provided by MedImmune LLC:

Primary Outcome Measures:

Safety and tolerability of motavizumab will be assessed primarily by summarizing adverse events [ Time Frame: Day 150 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

The incidence of RSV hospitalization and the incidence of RSV-specific, medically-attended outpatient LRI. [ Time Frame: Day 150 ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	800
Study Start Date:	October 2007
Estimated Study Completion Date:	September 2008
Primary Completion Date:	May 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator Motavizumab	Biological: Motavizumab Examples: A patient who weighs 4.90 kg at the time of injection receives 0.74 mL of study drug (4.90 kg x 15 mg/kg) ÷ 100 mg/mL = 0.735 mL (rounded to 0.74 mL) A patient who weighs 3.70 kg at the time of injection receives 0.56 mL of study drug (3.70 kg x 15 mg/kg) ÷ 100 mg/mL = 0.555 mL (rounded to 0.56 mL)
2 Palivizumab (Liquid Form)	Biological: Palivizumab 15 mg/kg IM administered at monthly intervals

Detailed Description:

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.

Eligibility

Ages Eligible for Study:	up to 24 Months
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

24 months of age or younger at randomization (child must be randomized on or before their 24-month birthday)
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.
Unoperated or partially corrected CHD
Written informed consent obtained from the patient's parent(s)/legal guardian(s)

Exclusion Criteria:

Unstable cardiac or respiratory status, including cardiac defects so severe that survival is not expected or for which cardiac transplantation is planned or anticipated
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 illness, or other acute infection or illness Note: children with any respiratory symptoms must have a negative RSV test prior to randomization
Chronic seizure or evolving or unstable neurologic disorder
Known immunodeficiency
Mother with HIV infection (unless the child has 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)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00538785

Show 35 Study Locations

Sponsors and Collaborators

MedImmune LLC

Investigators

Study Director:

Pamela Griffin, 301-398-0000

MedImmune LLC

More Information

Responsible Party:	MedImmune Inc. ( Pamela Griffin, M.D. )
Study ID Numbers:	MI-CP124-S2
Study First Received:	October 1, 2007
Last Updated:	September 18, 2008
ClinicalTrials.gov Identifier:	NCT00538785
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Antibodies, Monoclonal
Virus Diseases
Antibodies
Heart Diseases
Cardiovascular Abnormalities

Congenital Abnormalities
Palivizumab
Heart Defects, Congenital
Immunoglobulins

Additional relevant MeSH terms:

Anti-Infective Agents
Therapeutic Uses
Cardiovascular Diseases
Antiviral Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009