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Clinical Trials/EUCTR2007-002070-61-HU
EUCTR2007-002070-61-HUActive, not recruitingNot Applicable

A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of MEDI-524, a Humanized Enhanced Potency Monoclonal Antibody Against Respiratory Syncytial Virus (RSV), in Children with Hemodynamically Significant Congenital Heart Disease.

MedImmune, LLC0 sites800 target enrollmentStarted: July 12, 2007Last updated:
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Drugs

Trial Snapshot

Phase
Not Applicable
Status
Active, not recruiting
Enrollment
800
Study OverviewEligibility CriteriaInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

No summary available.

Study Design

Study Type
Interventional clinical trial of medicinal product

Eligibility Criteria

Sex
All

Inclusion Criteria

  • •Children must meet all of the following criteria:
  • •1. 24 months of age or younger at randomization (child must be randomized on or before their 24-month birthday).
  • •2. 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.
  • •3. Unoperated or partially corrected CHD.
  • •4. Written informed consent obtained from the patient’s parent(s)/legal guardian(s).
  • •Are the trial subjects under 18? yes
  • •Number of subjects for this age range:
  • •F.1.2 Adults (18-64 years) no
  • •F.1.2.1 Number of subjects for this age range
  • •F.1.3 Elderly (>=65 years) no
  • •F.1.3.1 Number of subjects for this age range

Exclusion Criteria

  • •Children must have none of the following:
  • •1. Unstable cardiac or respiratory status, including cardiac defects so severe that survival is not expected or for which cardiac transplantation is planned or anticipated.
  • •2. Hospitalization, unless discharge is anticipated within 21 days.
  • •3. Anticipated cardiac surgery within two weeks of randomization.
  • •4. Requirement for mechanical ventilation, extracorporeal membrane oxygenation, continuous positive airway pressure or other mechanical respiratory or cardiac support.
  • •5. Associated non-cardiac anomalies or end organ dysfunction resulting in anticipated survival of less than six months or unstable abnormalities of end organ function.
  • •6. Acute respiratory illness, or other acute infection or illness.
  • •Note: children with any respiratory symptoms must have a negative RSV test prior to randomization.
  • •7. Chronic seizure or evolving or unstable neurologic disorder.
  • •8. Known immunodeficiency.
  • •9. Mother with HIV infection (unless the child has been proven to be not infected).
  • •10. Known allergy to Ig products.
  • •11. Receipt of any polyclonal antibody (for example, Hepatitis B IG, IVIG, VZIG) within 3 months prior to randomization.
  • •12. Receipt of palivizumab (Synagis®) within 3 months prior to randomization.
  • •13. 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).
  • •14. Current participation in other investigational protocols of drugs or biological agents.
  • •15. Previous participation in MI-CP124 (Season 1).

Investigators

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