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

MedImmune

Status and phase: Completed; Phase 2

Conditions: Congenital Heart Disease

Treatments: Biological: Palivizumab; Biological: Motavizumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT00538785

MI-CP124-S2

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 1,236 patients

Sex: All

Ages: Under 24 months old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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.

Exclusion criteria

• 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)

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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1,236 participants in 2 patient groups

Motavizumab

Experimental group

Description:

Motavizumab was administered as an intramuscular injection at 15 mg/kg every 30 days during the RSV season for a maximum of 5 scheduled doses. Additionally, children who underwent cardiac surgery with cardiopulmonary bypass through Study Day 150 were to receive a protocol-specified replacement dose of study drug immediately following the surgery when determined by the physician to be medically stable for an IM injection.

Treatment:

Biological: Motavizumab

Pailvizumab

Active Comparator group

Description:

Palivizumab was administered as an intramuscular injection at 15 mg/kg every 30 days during the RSV season for a maximum of 5 scheduled doses. Additionally, children who underwent cardiac surgery with cardiopulmonary bypass through Study Day 150 were to receive a protocol-specified replacement dose of study drug immediately following the surgery when determined by the physician to be medically stable for an IM injection.

Treatment:

Biological: Palivizumab