A Study to Evaluate MEDI-524 In Children With Hemodynamically Significant Congenital Heart Disease
NCT ID: NCT00538785
Last Updated: 2012-02-16
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
1236 participants
INTERVENTIONAL
2005-10-31
2008-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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Motavizumab
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.
Motavizumab
15 mg/kg IM administered at monthly intervals
Pailvizumab
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.
Palivizumab
15 mg/kg IM administered at monthly intervals
Interventions
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Motavizumab
15 mg/kg IM administered at monthly intervals
Palivizumab
15 mg/kg IM administered at monthly intervals
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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)
24 Months
ALL
No
Sponsors
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MedImmune LLC
INDUSTRY
Responsible Party
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MedImmune, LLC
Principal Investigators
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Pamela Griffin, 301-398-0000
Role: STUDY_DIRECTOR
MedImmune LLC
Locations
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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 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
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States
Rhode Island Hospital
Providence, Rhode Island, United States
Children's Cardiology Associates PLLC
Austin, Texas, United States
Texas Children's Hospital
Houston, Texas, United States
University of Virginia
Charlottesville, Virginia, United States
Universitätsklinik für Kinder- und Jugendheilkunde
Innsbruck, , Austria
Allgemeines Krankenhaus Linz
Linz, , Austria
Universitätsklinik für Kinder- und Jugendheilkunde
Wein, , Austria
Ziekenhuisnetwerk Antwerpen - Koningin Paola Kinderziekenhuis
Antwerp, , Belgium
UZ Brussel
Brussells, , Belgium
Hôpital Universitaire des Enfants Reine
Brussels, , Belgium
UZ Brussel
Brussels, , Belgium
Cliniques Universitaires Saint-Luc
Brussels, , Belgium
UZ Antwerpen
Edegem, , Belgium
UZ Gent
Ghent, , Belgium
UZ Leuven
Leuven, , Belgium
CHR de la Citadelle
Liège, , Belgium
University Multifunctional Hospital for Active Treatment
Pleven, , Bulgaria
University Mulitiprofile Hospital for Active Treatment "St.Georgi"
Plovdiv, , Bulgaria
Multifunctional Hospital for Active Treatment - Pleven
Plovdiv, , Bulgaria
Regional Dispensary for Pulmonary Diseases with Inpatient sector-Rousse
Rousse, , Bulgaria
Specialized Hospital for Active Treatment of Cardio-vascular Diseases
Sofia, , Bulgaria
Specialized Hospital for Active Treatment of Pediatric Diseases
Sofia, , Bulgaria
University Multifunctional Hospital for Active Treatment
Stara Zagora, , Bulgaria
Multifunctional Hospital for Active Treatment - Pleven
Varna, , Bulgaria
Children's and Women's Hospital of BC, Room #1R11
Vancouver, British Columbia, Canada
IWK Health Center
Halifax, Nova Scotia, Canada
The Hospital for Sick Children
Toronto, Ontario, Canada
University of Alberta
Edmonton, , Canada
Montreal Children's Hospital
Montreal, , Canada
Saint Justine Hospital
Montreal, , Canada
Children's Hospital Of Eastern Ontario
Ottawa, , Canada
Saskatchewan Drug Research Institute
Saskatoon SK, , Canada
Fakultni nemocnice Hradec Kralove
Hradec Králové, , Czechia
Nemocnice Most, prispevkova organizace
Most, , Czechia
Fakultni nemocnice Plzen
Plzen - Lochotin, , Czechia
Vseobecna fakultni nemocnice v Praze
Prague, , Czechia
Ustav pro peci o matku a dite
Prague, , Czechia
Fakultni nemocnice v Motole
Prague, , Czechia
Fakultni nemocnice Na Bulovce
Prague, , Czechia
Skejby Sygehus
Århus N, , Denmark
Groupe Hospitalier Pelligrin
Bordeaux, , France
CHRU Dijon-Complex du Bocage
Dijon, , France
Centre chirurgical Marie Lannelongue
Le Plessis-Robinson, , France
Hospital de la Conception
Marseille, , France
Hospital Robert Debre
Paris, , France
American Memorial Hospital
Reims, , France
Hospital de Hautepierre
Strasbourg, , France
Hospitaux de Brabois
Vandœuvre-lès-Nancy, , France
Herz- und Diabeteszentrum NRW
Bad Oeynhausen, , Germany
Friedrich-Alexander-Universiät Erlangen Nürnberg
Freiburg im Breisgau, , Germany
Medizinische Hochschule Hannover
Hanover, , Germany
Universitätsklinikum Schleswig Holstein
Kiel, , Germany
Johannes Gutenberg-Universität
Mainz, , Germany
LMU Klinikum der Universität
München, , Germany
Klinikum Oldenburg
Oldenburg, , Germany
Universitätsklinik Rostock
Rostock, , Germany
Universitätsklinik Rostock
Rostock, , Germany
Universitätsklinikum Tübingen
Tübingen, , Germany
Semmelweis Egyetem
Budapest, , Hungary
Gottsegen Gyorgy Orszagos Kardiologiai Intezet, Gyermeksziv Kozpont
Budapest, , Hungary
Debreceni Egyetem OEC
Debrecen, , Hungary
Petz Aladar Megyei Korhaz
Győr, , Hungary
Borsod-Abaúj-Zemplén Megyei Kórház és Egyetemi Oktató Kórház
Miskolc, , Hungary
Josa Andras Korhaz
Nyíregyháza, , Hungary
Pecsi Tudomanyegyetem
Pécs, , Hungary
Szegedi Tudomanyegyetem AOK, Gyermekgyogyaszati Klinika
Szeged, , Hungary
Veszprém Megyei Önkormányzat - Csolnoky Ferenc Kórház
Veszprém, , Hungary
Soroka University Medical Center
Beersheba, , Israel
Rambam Medical Center
Haifa, , Israel
Edith Wolfson Medical Center
Holon, , Israel
Shaare Zedek Medical Center
Jerusalem, , Israel
Hadassah University Hospital Ein Kerem
Jerusalem, , Israel
Schneider Children's Medical Center of Israel
Petah Tikva, , Israel
The Chaim Sheba Medical Center
Ramat Gan, , Israel
Tel-Aviv Sourasky Medical Center
Tel Aviv, , Israel
The Chaim Sheba Medical Center
Tel Litwinsky, , Israel
St George University Hospital
Achrafieh- Beirut, , Lebanon
American University of Beirut Medical Center
Beirut, , Lebanon
Hotel Dieu De France
Beirut, , Lebanon
Samodzielny Publiczny Szpital Akademii Medycznej
Bialystok, , Poland
Samodzielny Publiczny Zaklad Opieki Zdrowotnej, Wojewodzki Szpital im. dr Jana Biziela w Bydgoszczy
Bydgoszcz, , Poland
Wojewodzki Szpital Dzieciecy W Bydgoszczy
Bydgoszcz, , Poland
Instytut Centrum Zdrowia Matki Polki
Lodz, , Poland
Dzieciecy Szpital Kliniczny im. Prof. Antoniego Gebal Poliklinika
Lubin, , Poland
Ginekologiczno-Poloznicy Szpital Kliniczny Uniwersytetu Medycznego w Poznaniu
Poznan, , Poland
Szpital Kliniczny Uniwersytetu Medycznego im. Karola Jonschera
Poznan, , Poland
Samodzielny Publiczny Szpital Kliniczny nr 1 im. Tadeusza Sokolowskiego Pomorskiej AM w Szczecinie
Szczecin, , Poland
Instytut "Pomnik - Centrum Zdrowia Dziecka"
Warsaw, , Poland
Kazan State Medical University
Kazan', , Russia
Kuban State Medical Academy
Krasnodar, , Russia
Meshalkin Research Institue of Blood circulation
Novosibirsk, , Russia
City Outpatient Clinic #113
Saint Petersburg, , Russia
Saint Petersburg State Pediatric Medical Academy
Saint Petersburg, , Russia
St. Petersburg City Children's Hospital #1
Saint Petersburg, , Russia
Research Cardiology Institute of Tomsk Scientific Center
Tomsk, , Russia
St. Petersburg Pediatric city hospital
Tyumen, , Russia
Hospital Juan Canalejo
A Coruña, , Spain
Hospital de Cruces
Barakaldo, , Spain
Hospital Vall d'Hebron
Barcelona, , Spain
Hospital Reina Sofia
Córdoba, , Spain
Hospital Donostia
Donostia / San Sebastian, , Spain
Hospital Universitario Virgen de la Arrixaca
El Palmar, , Spain
Hospital Sant Joan de Deu
Esplugas de Llobregat, , Spain
Hospital Josep Trueta
Girona, , Spain
Hospital Universitario Virgen de Las Nieves
Granada, , Spain
Hospital Materno Infantil de Jaen
Jaén, , Spain
Hospital de Jerez
Jerez de la Frontera, , Spain
Hospital Gregorio Marañon
Madrid, , Spain
Hospital La Paz
Madrid, , Spain
Hospital 12 de Octubre
Madrid, , Spain
Hospital Materno Infantil
Málaga, , Spain
Hospital Infantil Universitario Virgen del Rocío
Seville, , Spain
Hospital Xeral de Vigo
Vigo, , Spain
Hospital Universitario Miguel Servet
Zaragoza, , Spain
Jan Sunnegardh's- Private Practice
Gothenburg, , Sweden
Universitetssjukhuset i Lund
Lund, , Sweden
Karolinska University Hospital
Stockholm, , Sweden
Akademiska Sjukhuset i Uppsala
Uppsala, , Sweden
Universitetssjukhuset i Lund
Uppsala, , Sweden
Royal Belfast Hospital for Sick Children
Belfast, , United Kingdom
Bristol Royal Hospital for Children
Bristol, , United Kingdom
Medway Maritime Hospital
Gillingham, , United Kingdom
Leeds General Infirmary
Leeds, , United Kingdom
University Hospitals of Leicester NHS Trust
Leicester, , United Kingdom
Royal Brompton Hospital
London, , United Kingdom
Southampton General Hospital
Southampton, , United Kingdom
Countries
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Other Identifiers
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MI-CP124-S2
Identifier Type: -
Identifier Source: org_study_id
NCT00240890
Identifier Type: -
Identifier Source: nct_alias
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