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

Phase 2

Completed

Conditions: Congenital Heart Disease

Registration Number: NCT00538785

Lead Sponsor: MedImmune LLC

Brief Summary: 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.

Detailed 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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 1236

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)

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Number of Subjects Reporting Adverse Events Through Study Day 150	Days 0-150	Adverse events were summarized by system organ class (SOC) and preferred term (using MedDRA Version 11.1) overall.
Number of Subjects Reporting Serious Adverse Events Through Study Day 150	Days 0-150	Serious adverse events were those that resulted in death; were life-threatening; resulted in subject hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability or incapacity; or were an important medical event that may not have resulted in death, threatened life, or required hospitalization and that, based on appropriate medical judgment, may have jeopardized the subject and may have required medical or surgical intervention to prevent one of the outcomes listed above.
Number of Subjects Reporting Laboratory Adverse Events	Days 0-150

Secondary Outcome Measures

Name	Time	Method
The Number of Subjects Hospitalized for RSV Infection.	Days 0-150	An RSV hospitalization was defined as one of the following: 1) Cardiac/respiratory hospitalization with a positive real-time RT-PCR RSV diagnostic test performed at a central laboratory, or 2) New onset of lower respiratory tract symptoms with an objective measure of worsening respiratory status in an already hospitalized subject with a positive real-time RT-PCR RSV diagnostic test performed at a central laboratory (nosocomial RSV hospitalization), or 3) Death demonstrated to be caused by RSV (based on virologic evidence and either clinical history or autopsy).
The Number of Subjects With RSV Outpatient MA-LRI for Season 2 Only.	Days 0-150	An RSV outpatient MA-LRI was defined as an outpatient medically-attended event designated by the principal investigator as a lower respiratory illness with a positive real-time RT-PCR RSV diagnostic test performed at a central laboratory.
Number of Subjects Who Had Anti-motavizumab Antibodies Detected	Days 0-150	ECLA-based method
Mean Trough Serum Concentration of Motavizumab at Pre-dose 1	Pre-dose 1	Trough serum concentrations (ug/mL) of motavizumab at pre-dose 1
Mean Trough Serum Concentration of Motavizumab at 30 Days Post-dose 1	30 days post-dose 1	Trough serum concentrations (ug/mL) of motavizumab at 30 days post-dose 1
Mean Trough Serum Concentration of Motavizumab at 30 Days Post-dose 2	30 days post-dose 2	Trough serum concentrations (ug/mL) of motavizumab at 30 days post-dose 2
Mean Trough Serum Concentration of Motavizumab at 30 Days Post-dose 3	30 days post-dose 3	Trough serum concentrations (ug/mL) of motavizumab at 30 days post-dose 3
Mean Trough Serum Concentration of Motavizumab at 30 Days Post-dose 4	30 days post-dose 4	Trough serum concentrations (ug/mL) of motavizumab at 30 days post-dose 4
Mean Trough Serum Concentrations of Motavizumab in Subjects Who Underwent Cardiac Surgery With Cardiopulmonary Bypass	Days 0-150	Subjects who underwent cardiac surgery with cardiopulmonary bypass through Study Day 150 were to have a blood sample taken for determination of study drug concentrations prior to receipt of another dose of study drug immediately following surgery.

Trial Locations

Locations (145): Arkansas Pediatric Clinic
🇺🇸
Little Rock, Arkansas, United States
Miller Children's Hospital
🇺🇸
Long Beach, California, United States
Childrens Hospital Los Angeles
🇺🇸
Los Angeles, California, United States
Children's Hospital and Research Center at Oakland
🇺🇸
Oakland, California, United States
University of California Davis Medical Center
🇺🇸
Sacramento, California, United States
Children's Hospital And Health Center
🇺🇸
San Diego, California, United States
Yale New Haven Children's Hospital
🇺🇸
New Haven, Connecticut, United States
Children's National Medical Center
🇺🇸
Washington, District of Columbia, United States
Nemours Children's Clinic Biomedical Research Department
🇺🇸
Orlando, Florida, United States
James Whitcomb Riley Hospital for Children
🇺🇸
Indianapolis, Indiana, United States
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Arkansas Pediatric Clinic
🇺🇸Little Rock, Arkansas, United States