A Study to Evaluate MEDI-524 In Children With Hemodynamically Significant Congenital Heart Disease
- Conditions
- Congenital Heart Disease
- Interventions
- Biological: MotavizumabBiological: Palivizumab
- 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
- 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.
- 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
- Arm && Interventions
Group Intervention Description Motavizumab 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. Pailvizumab Palivizumab 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.
- 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)
University of Maryland
🇺🇸Baltimore, Maryland, United States
Johns Hopkins Hospital
🇺🇸Baltimore, Maryland, United States
Washington University School of Medicine
🇺🇸St. Louis, Missouri, United States
Children's Hospital of Philadelphia
🇺🇸Philadelphia, Pennsylvania, United States
Childrens Hospital Los Angeles
🇺🇸Los Angeles, California, United States
Universitätsklinik für Kinder- und Jugendheilkunde
🇦🇹Wein, Austria
Akron Children's Hospital
🇺🇸Akron, Ohio, United States
Univ. of North Carolina
🇺🇸Chapel Hill, North Carolina, United States
Miller Children's Hospital
🇺🇸Long Beach, California, United States
Children's Mercy Hospital
🇺🇸Kansas City, Missouri, United States
Nemours Children's Clinic Biomedical Research Department
🇺🇸Orlando, Florida, United States
University of California Davis Medical Center
🇺🇸Sacramento, California, United States
UZ Antwerpen
🇧🇪Edegem, Belgium
Saint Justine Hospital
🇨🇦Montreal, Canada
University of Alberta
🇨🇦Edmonton, Canada
Children's Hospital of Michigan
🇺🇸Detroit, Michigan, United States
Suny At Stony Brook University Medical Center
🇺🇸Stony Brook, New York, United States
Allgemeines Krankenhaus Linz
🇦🇹Linz, Austria
CHRU Dijon-Complex du Bocage
🇫🇷Dijon, France
Mayo Clinic
🇺🇸Rochester, Minnesota, United States
Centre chirurgical Marie Lannelongue
🇫🇷Le Plessis Robinson, France
University Mulitiprofile Hospital for Active Treatment "St.Georgi"
🇧🇬Plovdiv, Bulgaria
Specialized Hospital for Active Treatment of Pediatric Diseases
🇧🇬Sofia, Bulgaria
Nemocnice Most, prispevkova organizace
🇨🇿Most, Czech Republic
Herz- und Diabeteszentrum NRW
🇩🇪Bad Oeynhausen, Germany
Johannes Gutenberg-Universität
🇩🇪Mainz, Germany
Hospital Robert Debre
🇫🇷Paris, France
Fakultni nemocnice Hradec Kralove
🇨🇿Hradec Kralove, Czech Republic
Petz Aladar Megyei Korhaz
🇭🇺Gyor, Hungary
Hospital de la Conception
🇫🇷Marseille, France
The Hospital for Sick Children
🇨🇦Toronto, Ontario, Canada
Hospital de Cruces
🇪🇸Barakaldo, Spain
Hospital Josep Trueta
🇪🇸Girona, Spain
Jan Sunnegardh's- Private Practice
🇸🇪Göteborg, Sweden
Universitetssjukhuset i Lund
🇸🇪Uppsala, Sweden
Cliniques Universitaires Saint-Luc
🇧🇪Bruxelles, Belgium
UZ Leuven
🇧🇪Leuven, Belgium
Groupe Hospitalier Pelligrin
🇫🇷Bordeaux, France
Montreal Children's Hospital
🇨🇦Montreal, Canada
Hospital Donostia
🇪🇸San Sebastian, Spain
Hospital La Paz
🇪🇸Madrid, Spain
Hospital Reina Sofia
🇪🇸Córdoba, Spain
Southampton General Hospital
🇬🇧Southampton, United Kingdom
American Memorial Hospital
🇫🇷Reims, France
Universitätsklinikum Schleswig Holstein
🇩🇪Kiel, Germany
Medizinische Hochschule Hannover
🇩🇪Hanover, Germany
Hospital Vall d'Hebron
🇪🇸Barcelona, Spain
Karolinska University Hospital
🇸🇪Stockholm, Sweden
Hospitaux de Brabois
🇫🇷Vandoeuvre les Nancy, France
Bristol Royal Hospital for Children
🇬🇧Bristol, United Kingdom
University Hospitals of Leicester NHS Trust
🇬🇧Leicester, United Kingdom
Friedrich-Alexander-Universiät Erlangen Nürnberg
🇩🇪Freiburg, Germany
Hospital Universitario Virgen de la Arrixaca
🇪🇸El Palmar, Spain
Universitätsklinik Rostock
🇩🇪Rostock, Germany
Josa Andras Korhaz
🇭🇺Nyiregyhaza, Hungary
Gottsegen Gyorgy Orszagos Kardiologiai Intezet, Gyermeksziv Kozpont
🇭🇺Budapest, Hungary
Royal Belfast Hospital for Sick Children
🇬🇧Belfast, United Kingdom
Hospital de Jerez
🇪🇸Jerez de la Frontera, Spain
Akademiska Sjukhuset i Uppsala
🇸🇪Uppsala, Sweden
Medway Maritime Hospital
🇬🇧Gillingham, United Kingdom
Leeds General Infirmary
🇬🇧Leeds, United Kingdom
Children's Hospital Boston
🇺🇸Boston, Massachusetts, United States
James Whitcomb Riley Hospital for Children
🇺🇸Indianapolis, Indiana, United States
Tufts - New England Medical Center
🇺🇸Boston, Massachusetts, United States
Children's Hospital And Health Center
🇺🇸San Diego, California, United States
Texas Children's Hospital
🇺🇸Houston, Texas, United States
Skejby Sygehus
🇩🇰Århus N, Denmark
Hospital de Hautepierre
🇫🇷Strasbourg, France
Saskatchewan Drug Research Institute
🇨🇦Saskatoon SK, Canada
Klinikum Oldenburg
🇩🇪Oldenburg, Germany
Hospital Materno Infantil de Jaen
🇪🇸Jaen, Spain
Hospital Juan Canalejo
🇪🇸La Coruña, Spain
Hospital 12 de Octubre
🇪🇸Madrid, Spain
University of Rochester
🇺🇸Rochester, New York, United States
Children's Cardiology Associates PLLC
🇺🇸Austin, Texas, United States
Children's Hospital of Oklahoma
🇺🇸Oklahoma City, Oklahoma, United States
Hospital Universitario Virgen de Las Nieves
🇪🇸Granada, Spain
University of Virginia
🇺🇸Charlottesville, Virginia, United States
Hospital Infantil Universitario Virgen del Rocío
🇪🇸Sevilla, Spain
Hospital Materno Infantil
🇪🇸Málaga, Spain
Hospital Xeral de Vigo
🇪🇸Vigo, Spain
Memorial Hospital of South Bend
🇺🇸South Bend, Indiana, United States
Children's Hospital and Research Center at Oakland
🇺🇸Oakland, California, United States
Regional Dispensary for Pulmonary Diseases with Inpatient sector-Rousse
🇧🇬Rousse, Bulgaria
Children's and Women's Hospital of BC, Room #1R11
🇨🇦Vancouver, British Columbia, Canada
Children's Hospital Of Eastern Ontario
🇨🇦Ottawa, Canada
Fakultni nemocnice v Motole
🇨🇿Praha 5, Czech Republic
LMU Klinikum der Universität
🇩🇪München, Germany
Universitätsklinikum Tübingen
🇩🇪Tübingen, Germany
Pecsi Tudomanyegyetem
🇭🇺Pecs, Hungary
Schneider Children's Medical Center of Israel
🇮🇱Petach Tikva, Israel
Shaare Zedek Medical Center
🇮🇱Jerusalem, Israel
Szegedi Tudomanyegyetem AOK, Gyermekgyogyaszati Klinika
🇭🇺Szeged, Hungary
Veszprém Megyei Önkormányzat - Csolnoky Ferenc Kórház
🇭🇺Veszprem, Hungary
St George University Hospital
🇱🇧Achrafieh- Beirut, Lebanon
Kazan State Medical University
🇷🇺Kazan, Russian Federation
Hospital Sant Joan de Deu
🇪🇸Esplugas de Llobregat, Spain
Hospital Gregorio Marañon
🇪🇸Madrid, Spain
Hospital Universitario Miguel Servet
🇪🇸Zaragoza, Spain
Hotel Dieu De France
🇱🇧Beirut, Lebanon
CHR de la Citadelle
🇧🇪Liège, Belgium
Fakultni nemocnice Na Bulovce
🇨🇿Praha 8, Czech Republic
Rambam Medical Center
🇮🇱Haifa, Israel
Tel-Aviv Sourasky Medical Center
🇮🇱Tel Aviv, Israel
Children's National Medical Center
🇺🇸Washington, District of Columbia, United States
Ziekenhuisnetwerk Antwerpen - Koningin Paola Kinderziekenhuis
🇧🇪Antwerpen, Belgium
UZ Gent
🇧🇪Gent, Belgium
The Chaim Sheba Medical Center
🇮🇱Tel Hashomer, Israel
American University of Beirut Medical Center
🇱🇧Beirut, Lebanon
Samodzielny Publiczny Zaklad Opieki Zdrowotnej, Wojewodzki Szpital im. dr Jana Biziela w Bydgoszczy
🇵🇱Bydgoszcz, Poland
Wojewodzki Szpital Dzieciecy W Bydgoszczy
🇵🇱Bydgoszcz, Poland
Ginekologiczno-Poloznicy Szpital Kliniczny Uniwersytetu Medycznego w Poznaniu
🇵🇱Poznan, Poland
Research Cardiology Institute of Tomsk Scientific Center
🇷🇺Tomsk, Russian Federation
Tulane University Health Sciences Center
🇺🇸New Orleans, Louisiana, United States
UZ Brussel
🇧🇪Brussells, Belgium
Specialized Hospital for Active Treatment of Cardio-vascular Diseases
🇧🇬Sofia, Bulgaria
Fakultni nemocnice Plzen
🇨🇿Plzen - Lochotin, Czech Republic
Debreceni Egyetem OEC
🇭🇺Debrecen, Hungary
Borsod-Abaúj-Zemplén Megyei Kórház és Egyetemi Oktató Kórház
🇭🇺Miskolc, Hungary
Hadassah University Hospital Ein Kerem
🇮🇱Jerusalem, Israel
Samodzielny Publiczny Szpital Akademii Medycznej
🇵🇱Bialystok, Poland
Kuban State Medical Academy
🇷🇺Krasnodar, Russian Federation
Meshalkin Research Institue of Blood circulation
🇷🇺Novosibirsk, Russian Federation
Saint Petersburg State Pediatric Medical Academy
🇷🇺St. Petersburg, Russian Federation
Arkansas Pediatric Clinic
🇺🇸Little Rock, Arkansas, United States
Ustav pro peci o matku a dite
🇨🇿Praha 4, Czech Republic
Szpital Kliniczny Uniwersytetu Medycznego im. Karola Jonschera
🇵🇱Poznan, Poland
Multifunctional Hospital for Active Treatment - Pleven
🇧🇬Varna, Bulgaria
Yale New Haven Children's Hospital
🇺🇸New Haven, Connecticut, United States
Semmelweis Egyetem
🇭🇺Budapest, Hungary
Hôpital Universitaire des Enfants Reine
🇧🇪Bruxelles, Belgium
University Multifunctional Hospital for Active Treatment
🇧🇬Stara Zagora, Bulgaria
Vseobecna fakultni nemocnice v Praze
🇨🇿Praha 2, Czech Republic
Soroka University Medical Center
🇮🇱Beer Sheva, Israel
Edith Wolfson Medical Center
🇮🇱Holon, Israel
Instytut Centrum Zdrowia Matki Polki
🇵🇱Lodz, Poland
Samodzielny Publiczny Szpital Kliniczny nr 1 im. Tadeusza Sokolowskiego Pomorskiej AM w Szczecinie
🇵🇱Szczecin, Poland
St. Petersburg City Children's Hospital #1
🇷🇺St. Petersburg, Russian Federation
IWK Health Center
🇨🇦Halifax, Nova Scotia, Canada
Dzieciecy Szpital Kliniczny im. Prof. Antoniego Gebal Poliklinika
🇵🇱Lubin, Poland
Instytut "Pomnik - Centrum Zdrowia Dziecka"
🇵🇱Warszawa, Poland
City Outpatient Clinic #113
🇷🇺St. Petersburg, Russian Federation
St. Petersburg Pediatric city hospital
🇷🇺Tyumen, Russian Federation
Royal Brompton Hospital
🇬🇧London, United Kingdom
Rhode Island Hospital
🇺🇸Providence, Rhode Island, United States