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

Completed · Phase 2

Conditions studied: Congenital Heart Disease

In brief

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.

Key facts

Study ID

NCT00538785

Run by

MedImmune LLC

People needed

1236

Starts

2005-10-01

Expected to finish

2008-06-01

Last updated by the study team

2012-02-16

Who can join

Age: any, up to 2. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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)

Where it is running

• 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 D.C., 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
• Memorial Hospital of South Bend — South Bend, Indiana, United States
• Tulane University Health Sciences Center — New Orleans, Louisiana, United States
• University of Maryland — Baltimore, Maryland, United States
• Johns Hopkins Hospital — Baltimore, Maryland, United States
• Tufts - New England Medical Center — Boston, Massachusetts, United States
• Children's Hospital Boston — Boston, Massachusetts, United States
• Children's Hospital of Michigan — Detroit, Michigan, United States
• Mayo Clinic — Rochester, Minnesota, United States
• Children's Mercy Hospital — Kansas City, Missouri, United States
• Washington University School of Medicine — St Louis, Missouri, United States
• University of Rochester — Rochester, New York, United States
• Suny At Stony Brook University Medical Center — Stony Brook, New York, United States
• Univ. of North Carolina — Chapel Hill, North Carolina, United States
• Akron Children's Hospital — Akron, Ohio, United States
• Children's Hospital of Oklahoma — Oklahoma City, Oklahoma, United States
• Arkansas Pediatric Clinic — Little Rock, Arkansas, United States

Full record on ClinicalTrials.gov

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