Congenital Heart Disease Clinical Trial
Official title:
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
Verified date | February 2012 |
Source | MedImmune LLC |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 1236 |
Est. completion date | June 2008 |
Est. primary completion date | June 2008 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | N/A to 24 Months |
Eligibility |
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) |
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
Austria | Universitätsklinik für Kinder- und Jugendheilkunde | Innsbruck | |
Austria | Allgemeines Krankenhaus Linz | Linz | |
Austria | Universitätsklinik für Kinder- und Jugendheilkunde | Wein | |
Belgium | Ziekenhuisnetwerk Antwerpen - Koningin Paola Kinderziekenhuis | Antwerpen | |
Belgium | UZ Brussel | Brussel, | |
Belgium | UZ Brussel | Brussells | |
Belgium | Cliniques Universitaires Saint-Luc | Bruxelles | |
Belgium | Hôpital Universitaire des Enfants Reine | Bruxelles | |
Belgium | UZ Antwerpen | Edegem | |
Belgium | UZ Antwerpen | Edegem, | |
Belgium | UZ Gent | Gent | |
Belgium | UZ Leuven | Leuven | |
Belgium | CHR de la Citadelle | Liège | |
Bulgaria | University Multifunctional Hospital for Active Treatment | Pleven | |
Bulgaria | Multifunctional Hospital for Active Treatment - Pleven | Plovdiv | |
Bulgaria | University Mulitiprofile Hospital for Active Treatment "St.Georgi" | 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 | |
Canada | University of Alberta | Edmonton | |
Canada | IWK Health Center | Halifax | Nova Scotia |
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 | The Hospital for Sick Children | Toronto | Ontario |
Canada | Children's and Women's Hospital of BC, Room #1R11 | Vancouver | British Columbia |
Czech Republic | Fakultni nemocnice Hradec Kralove | Hradec Kralove | |
Czech Republic | Nemocnice Most, prispevkova organizace | Most | |
Czech Republic | Fakultni nemocnice Plzen | Plzen - Lochotin | |
Czech Republic | Vseobecna fakultni nemocnice v Praze | Praha 2 | |
Czech Republic | Ustav pro peci o matku a dite | Praha 4 | |
Czech Republic | Fakultni nemocnice v Motole | Praha 5 | |
Czech Republic | Fakultni nemocnice Na Bulovce | Praha 8 | |
Denmark | Skejby Sygehus | Århus N | |
France | 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 | Vandoeuvre les Nancy | |
Germany | Herz- und Diabeteszentrum NRW | Bad Oeynhausen | |
Germany | Friedrich-Alexander-Universiät Erlangen Nürnberg | Freiburg | |
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 | |
Hungary | Gottsegen Gyorgy Orszagos Kardiologiai Intezet, Gyermeksziv Kozpont | Budapest | |
Hungary | Semmelweis Egyetem | Budapest | |
Hungary | Debreceni Egyetem OEC | Debrecen | |
Hungary | Petz Aladar Megyei Korhaz | Gyor | |
Hungary | Borsod-Abaúj-Zemplén Megyei Kórház és Egyetemi Oktató Kórház | Miskolc | |
Hungary | Josa Andras Korhaz | Nyiregyhaza | |
Hungary | Pecsi Tudomanyegyetem | Pecs | |
Hungary | Szegedi Tudomanyegyetem AOK, Gyermekgyogyaszati Klinika | Szeged | |
Hungary | Veszprém Megyei Önkormányzat - Csolnoky Ferenc Kórház | Veszprem | |
Israel | Soroka University Medical Center | Beer Sheva | |
Israel | Rambam Medical Center | Haifa | |
Israel | Edith Wolfson Medical Center | Holon | |
Israel | Hadassah University Hospital Ein Kerem | Jerusalem | |
Israel | Shaare Zedek Medical Center | Jerusalem | |
Israel | Schneider Children's Medical Center of Israel | Petach Tikva | |
Israel | The Chaim Sheba Medical Center | Ramat-Gan | |
Israel | Tel-Aviv Sourasky Medical Center | Tel Aviv | |
Israel | The Chaim Sheba Medical Center | Tel Hashomer | |
Lebanon | St George University Hospital | Achrafieh- Beirut | |
Lebanon | American University of Beirut Medical Center | Beirut | |
Lebanon | Hotel Dieu De France | Beirut | |
Poland | 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" | Warszawa | |
Russian Federation | Kazan State Medical University | Kazan | |
Russian Federation | Kuban State Medical Academy | Krasnodar | |
Russian Federation | Meshalkin Research Institue of Blood circulation | Novosibirsk | |
Russian Federation | City Outpatient Clinic #113 | St. Petersburg | |
Russian Federation | Saint Petersburg State Pediatric Medical Academy | St. Petersburg | |
Russian Federation | St. Petersburg City Children's Hospital #1 | St. Petersburg | |
Russian Federation | Research Cardiology Institute of Tomsk Scientific Center | Tomsk | |
Russian Federation | St. Petersburg Pediatric city hospital | Tyumen | |
Spain | Hospital de Cruces | Barakaldo | |
Spain | Hospital Vall d'Hebron | Barcelona | |
Spain | Hospital Reina Sofia | Córdoba | |
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 | Jaen | |
Spain | Hospital de Jerez | Jerez de la Frontera | |
Spain | Hospital Juan Canalejo | La Coruña | |
Spain | Hospital 12 de Octubre | Madrid | |
Spain | Hospital Gregorio Marañon | Madrid | |
Spain | Hospital La Paz | Madrid | |
Spain | Hospital Materno Infantil | Málaga | |
Spain | Hospital Donostia | San Sebastian | |
Spain | Hospital Infantil Universitario Virgen del Rocío | Sevilla | |
Spain | Hospital Xeral de Vigo | Vigo | |
Spain | Hospital Universitario Miguel Servet | Zaragoza | |
Sweden | Jan Sunnegardh's- Private Practice | Göteborg | |
Sweden | Universitetssjukhuset i Lund | Lund | |
Sweden | Karolinska University Hospital | Stockholm | |
Sweden | Akademiska Sjukhuset i Uppsala | Uppsala | |
Sweden | Universitetssjukhuset i Lund | Uppsala | |
United Kingdom | 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 States | Akron Children's Hospital | Akron | Ohio |
United States | Children's Cardiology Associates PLLC | Austin | Texas |
United States | Johns Hopkins Hospital | Baltimore | Maryland |
United States | University of Maryland | Baltimore | Maryland |
United States | Children's Hospital Boston | Boston | Massachusetts |
United States | Tufts - New England Medical Center | Boston | Massachusetts |
United States | Univ. of North Carolina | Chapel Hill | North Carolina |
United States | University of Virginia | Charlottesville | Virginia |
United States | Children's Hospital of Michigan | Detroit | Michigan |
United States | Texas Children's Hospital | Houston | Texas |
United States | James Whitcomb Riley Hospital for Children | Indianapolis | Indiana |
United States | Children's Mercy Hospital | Kansas City | Missouri |
United States | 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 | Yale New Haven Children's Hospital | New Haven | Connecticut |
United States | Tulane University Health Sciences Center | New Orleans | Louisiana |
United States | Children's Hospital and Research Center at Oakland | Oakland | California |
United States | Children's Hospital of Oklahoma | Oklahoma City | Oklahoma |
United States | Nemours Children's Clinic Biomedical Research Department | Orlando | Florida |
United States | Children's Hospital of Philadelphia | Philadelphia | Pennsylvania |
United States | Rhode Island Hospital | Providence | Rhode Island |
United States | Mayo Clinic | Rochester | Minnesota |
United States | University of Rochester | Rochester | New York |
United States | University of California Davis Medical Center | Sacramento | California |
United States | Children's Hospital And Health Center | San Diego | California |
United States | Memorial Hospital of South Bend | South Bend | Indiana |
United States | Washington University School of Medicine | St. Louis | Missouri |
United States | Suny At Stony Brook University Medical Center | Stony Brook | New York |
United States | Children's National Medical Center | Washington | District of Columbia |
Lead Sponsor | Collaborator |
---|---|
MedImmune LLC |
United States, Austria, Belgium, Bulgaria, Canada, Czech Republic, Denmark, France, Germany, Hungary, Israel, Lebanon, Poland, Russian Federation, Spain, Sweden, United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of Subjects Reporting Adverse Events Through Study Day 150 | Adverse events were summarized by system organ class (SOC) and preferred term (using MedDRA Version 11.1) overall. | Days 0-150 | Yes |
Primary | Number of Subjects Reporting Serious Adverse Events Through Study Day 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. | Days 0-150 | Yes |
Primary | Number of Subjects Reporting Laboratory Adverse Events | Days 0-150 | Yes | |
Secondary | The Number of Subjects Hospitalized for RSV Infection. | 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). | Days 0-150 | No |
Secondary | The Number of Subjects With RSV Outpatient MA-LRI for Season 2 Only. | 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. | Days 0-150 | No |
Secondary | Number of Subjects Who Had Anti-motavizumab Antibodies Detected | ECLA-based method | Days 0-150 | Yes |
Secondary | Mean Trough Serum Concentration of Motavizumab at Pre-dose 1 | Trough serum concentrations (ug/mL) of motavizumab at pre-dose 1 | Pre-dose 1 | No |
Secondary | Mean Trough Serum Concentration of Motavizumab at 30 Days Post-dose 1 | Trough serum concentrations (ug/mL) of motavizumab at 30 days post-dose 1 | 30 days post-dose 1 | No |
Secondary | Mean Trough Serum Concentration of Motavizumab at 30 Days Post-dose 2 | Trough serum concentrations (ug/mL) of motavizumab at 30 days post-dose 2 | 30 days post-dose 2 | No |
Secondary | Mean Trough Serum Concentration of Motavizumab at 30 Days Post-dose 3 | Trough serum concentrations (ug/mL) of motavizumab at 30 days post-dose 3 | 30 days post-dose 3 | No |
Secondary | Mean Trough Serum Concentration of Motavizumab at 30 Days Post-dose 4 | Trough serum concentrations (ug/mL) of motavizumab at 30 days post-dose 4 | 30 days post-dose 4 | No |
Secondary | Mean Trough Serum Concentrations of Motavizumab in Subjects Who Underwent Cardiac Surgery With Cardiopulmonary Bypass | 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. | Days 0-150 | No |
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