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

Primary Purpose

Congenital Heart Disease

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Motavizumab
Palivizumab
Sponsored by
MedImmune LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Congenital Heart Disease focused on measuring Synagis, motavizumab, palivizumab, children, MEDI-524, RSV, congenital hear disease

Eligibility Criteria

undefined - 24 Months (Child)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Arkansas Pediatric Clinic
  • Miller Children's Hospital
  • Childrens Hospital Los Angeles
  • Children's Hospital and Research Center at Oakland
  • University of California Davis Medical Center
  • Children's Hospital And Health Center
  • Yale New Haven Children's Hospital
  • Children's National Medical Center
  • Nemours Children's Clinic Biomedical Research Department
  • James Whitcomb Riley Hospital for Children
  • Memorial Hospital of South Bend
  • Tulane University Health Sciences Center
  • University of Maryland
  • Johns Hopkins Hospital
  • Tufts - New England Medical Center
  • Children's Hospital Boston
  • Children's Hospital of Michigan
  • Mayo Clinic
  • Children's Mercy Hospital
  • Washington University School of Medicine
  • University of Rochester
  • Suny At Stony Brook University Medical Center
  • Univ. of North Carolina
  • Akron Children's Hospital
  • Children's Hospital of Oklahoma
  • Children's Hospital of Philadelphia
  • Rhode Island Hospital
  • Children's Cardiology Associates PLLC
  • Texas Children's Hospital
  • University of Virginia
  • Universitätsklinik für Kinder- und Jugendheilkunde
  • Allgemeines Krankenhaus Linz
  • Universitätsklinik für Kinder- und Jugendheilkunde
  • Ziekenhuisnetwerk Antwerpen - Koningin Paola Kinderziekenhuis
  • UZ Brussel
  • UZ Brussel
  • Hôpital Universitaire des Enfants Reine
  • Cliniques Universitaires Saint-Luc
  • UZ Antwerpen
  • UZ Antwerpen
  • UZ Gent
  • UZ Leuven
  • CHR de la Citadelle
  • University Multifunctional Hospital for Active Treatment
  • University Mulitiprofile Hospital for Active Treatment "St.Georgi"
  • Multifunctional Hospital for Active Treatment - Pleven
  • Regional Dispensary for Pulmonary Diseases with Inpatient sector-Rousse
  • Specialized Hospital for Active Treatment of Cardio-vascular Diseases
  • Specialized Hospital for Active Treatment of Pediatric Diseases
  • University Multifunctional Hospital for Active Treatment
  • Multifunctional Hospital for Active Treatment - Pleven
  • Children's and Women's Hospital of BC, Room #1R11
  • IWK Health Center
  • The Hospital for Sick Children
  • University of Alberta
  • Montreal Children's Hospital
  • Saint Justine Hospital
  • Children's Hospital Of Eastern Ontario
  • Saskatchewan Drug Research Institute
  • Fakultni nemocnice Hradec Kralove
  • Nemocnice Most, prispevkova organizace
  • Fakultni nemocnice Plzen
  • Vseobecna fakultni nemocnice v Praze
  • Ustav pro peci o matku a dite
  • Fakultni nemocnice v Motole
  • Fakultni nemocnice Na Bulovce
  • Skejby Sygehus
  • Groupe Hospitalier Pelligrin
  • CHRU Dijon-Complex du Bocage
  • Centre chirurgical Marie Lannelongue
  • Hospital de la Conception
  • Hospital Robert Debre
  • American Memorial Hospital
  • Hospital de Hautepierre
  • Hospitaux de Brabois
  • Herz- und Diabeteszentrum NRW
  • Friedrich-Alexander-Universiät Erlangen Nürnberg
  • Medizinische Hochschule Hannover
  • Universitätsklinikum Schleswig Holstein
  • Johannes Gutenberg-Universität
  • LMU Klinikum der Universität
  • Klinikum Oldenburg
  • Universitätsklinik Rostock
  • Universitätsklinik Rostock
  • Universitätsklinikum Tübingen
  • Semmelweis Egyetem
  • Gottsegen Gyorgy Orszagos Kardiologiai Intezet, Gyermeksziv Kozpont
  • Debreceni Egyetem OEC
  • Petz Aladar Megyei Korhaz
  • Borsod-Abaúj-Zemplén Megyei Kórház és Egyetemi Oktató Kórház
  • Josa Andras Korhaz
  • Pecsi Tudomanyegyetem
  • Szegedi Tudomanyegyetem AOK, Gyermekgyogyaszati Klinika
  • Veszprém Megyei Önkormányzat - Csolnoky Ferenc Kórház
  • Soroka University Medical Center
  • Rambam Medical Center
  • Edith Wolfson Medical Center
  • Shaare Zedek Medical Center
  • Hadassah University Hospital Ein Kerem
  • Schneider Children's Medical Center of Israel
  • The Chaim Sheba Medical Center
  • Tel-Aviv Sourasky Medical Center
  • The Chaim Sheba Medical Center
  • St George University Hospital
  • American University of Beirut Medical Center
  • Hotel Dieu De France
  • Samodzielny Publiczny Szpital Akademii Medycznej
  • Samodzielny Publiczny Zaklad Opieki Zdrowotnej, Wojewodzki Szpital im. dr Jana Biziela w Bydgoszczy
  • Wojewodzki Szpital Dzieciecy W Bydgoszczy
  • Instytut Centrum Zdrowia Matki Polki
  • Dzieciecy Szpital Kliniczny im. Prof. Antoniego Gebal Poliklinika
  • Ginekologiczno-Poloznicy Szpital Kliniczny Uniwersytetu Medycznego w Poznaniu
  • Szpital Kliniczny Uniwersytetu Medycznego im. Karola Jonschera
  • Samodzielny Publiczny Szpital Kliniczny nr 1 im. Tadeusza Sokolowskiego Pomorskiej AM w Szczecinie
  • Instytut "Pomnik - Centrum Zdrowia Dziecka"
  • Kazan State Medical University
  • Kuban State Medical Academy
  • Meshalkin Research Institue of Blood circulation
  • City Outpatient Clinic #113
  • Saint Petersburg State Pediatric Medical Academy
  • St. Petersburg City Children's Hospital #1
  • Research Cardiology Institute of Tomsk Scientific Center
  • St. Petersburg Pediatric city hospital
  • Hospital de Cruces
  • Hospital Vall d'Hebron
  • Hospital Reina Sofia
  • Hospital Universitario Virgen de la Arrixaca
  • Hospital Sant Joan de Deu
  • Hospital Josep Trueta
  • Hospital Universitario Virgen de Las Nieves
  • Hospital Materno Infantil de Jaen
  • Hospital de Jerez
  • Hospital Juan Canalejo
  • Hospital Gregorio Marañon
  • Hospital La Paz
  • Hospital 12 de Octubre
  • Hospital Materno Infantil
  • Hospital Donostia
  • Hospital Infantil Universitario Virgen del Rocío
  • Hospital Xeral de Vigo
  • Hospital Universitario Miguel Servet
  • Jan Sunnegardh's- Private Practice
  • Universitetssjukhuset i Lund
  • Karolinska University Hospital
  • Akademiska Sjukhuset i Uppsala
  • Universitetssjukhuset i Lund
  • Royal Belfast Hospital for Sick Children
  • Bristol Royal Hospital for Children
  • Medway Maritime Hospital
  • Leeds General Infirmary
  • University Hospitals of Leicester NHS Trust
  • Royal Brompton Hospital
  • Southampton General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Motavizumab

Pailvizumab

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.
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.
Number of Subjects Reporting Laboratory Adverse Events

Secondary Outcome Measures

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).
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.
Number of Subjects Who Had Anti-motavizumab Antibodies Detected
ECLA-based method
Mean Trough Serum Concentration of Motavizumab at 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
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
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
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
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
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.

Full Information

First Posted
October 1, 2007
Last Updated
February 14, 2012
Sponsor
MedImmune LLC
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1. Study Identification

Unique Protocol Identification Number
NCT00538785
Brief Title
A Study to Evaluate MEDI-524 In Children With Hemodynamically Significant Congenital Heart Disease
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2012
Overall Recruitment Status
Completed
Study Start Date
October 2005 (undefined)
Primary Completion Date
June 2008 (Actual)
Study Completion Date
June 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
MedImmune LLC

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Congenital Heart Disease
Keywords
Synagis, motavizumab, palivizumab, children, MEDI-524, RSV, congenital hear disease

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
1236 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Motavizumab
Arm Type
Experimental
Arm Description
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.
Arm Title
Pailvizumab
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Biological
Intervention Name(s)
Motavizumab
Other Intervention Name(s)
Medi-524
Intervention Description
15 mg/kg IM administered at monthly intervals
Intervention Type
Biological
Intervention Name(s)
Palivizumab
Other Intervention Name(s)
Synagis
Intervention Description
15 mg/kg IM administered at monthly intervals
Primary Outcome Measure Information:
Title
Number of Subjects Reporting Adverse Events Through Study Day 150
Description
Adverse events were summarized by system organ class (SOC) and preferred term (using MedDRA Version 11.1) overall.
Time Frame
Days 0-150
Title
Number of Subjects Reporting Serious Adverse Events Through Study Day 150
Description
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.
Time Frame
Days 0-150
Title
Number of Subjects Reporting Laboratory Adverse Events
Time Frame
Days 0-150
Secondary Outcome Measure Information:
Title
The Number of Subjects Hospitalized for RSV Infection.
Description
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).
Time Frame
Days 0-150
Title
The Number of Subjects With RSV Outpatient MA-LRI for Season 2 Only.
Description
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.
Time Frame
Days 0-150
Title
Number of Subjects Who Had Anti-motavizumab Antibodies Detected
Description
ECLA-based method
Time Frame
Days 0-150
Title
Mean Trough Serum Concentration of Motavizumab at Pre-dose 1
Description
Trough serum concentrations (ug/mL) of motavizumab at pre-dose 1
Time Frame
Pre-dose 1
Title
Mean Trough Serum Concentration of Motavizumab at 30 Days Post-dose 1
Description
Trough serum concentrations (ug/mL) of motavizumab at 30 days post-dose 1
Time Frame
30 days post-dose 1
Title
Mean Trough Serum Concentration of Motavizumab at 30 Days Post-dose 2
Description
Trough serum concentrations (ug/mL) of motavizumab at 30 days post-dose 2
Time Frame
30 days post-dose 2
Title
Mean Trough Serum Concentration of Motavizumab at 30 Days Post-dose 3
Description
Trough serum concentrations (ug/mL) of motavizumab at 30 days post-dose 3
Time Frame
30 days post-dose 3
Title
Mean Trough Serum Concentration of Motavizumab at 30 Days Post-dose 4
Description
Trough serum concentrations (ug/mL) of motavizumab at 30 days post-dose 4
Time Frame
30 days post-dose 4
Title
Mean Trough Serum Concentrations of Motavizumab in Subjects Who Underwent Cardiac Surgery With Cardiopulmonary Bypass
Description
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.
Time Frame
Days 0-150

10. Eligibility

Sex
All
Maximum Age & Unit of Time
24 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pamela Griffin, 301-398-0000
Organizational Affiliation
MedImmune LLC
Official's Role
Study Director
Facility Information:
Facility Name
Arkansas Pediatric Clinic
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
Facility Name
Miller Children's Hospital
City
Long Beach
State/Province
California
ZIP/Postal Code
90806
Country
United States
Facility Name
Childrens Hospital Los Angeles
City
Los Angeles
State/Province
California
ZIP/Postal Code
90027
Country
United States
Facility Name
Children's Hospital and Research Center at Oakland
City
Oakland
State/Province
California
ZIP/Postal Code
94609
Country
United States
Facility Name
University of California Davis Medical Center
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
Facility Name
Children's Hospital And Health Center
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
Yale New Haven Children's Hospital
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06520-8064
Country
United States
Facility Name
Children's National Medical Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20010
Country
United States
Facility Name
Nemours Children's Clinic Biomedical Research Department
City
Orlando
State/Province
Florida
ZIP/Postal Code
32801
Country
United States
Facility Name
James Whitcomb Riley Hospital for Children
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
Memorial Hospital of South Bend
City
South Bend
State/Province
Indiana
ZIP/Postal Code
46601
Country
United States
Facility Name
Tulane University Health Sciences Center
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70112
Country
United States
Facility Name
University of Maryland
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Facility Name
Johns Hopkins Hospital
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Facility Name
Tufts - New England Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02111
Country
United States
Facility Name
Children's Hospital Boston
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Children's Hospital of Michigan
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
Children's Mercy Hospital
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64108
Country
United States
Facility Name
Washington University School of Medicine
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
University of Rochester
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
Facility Name
Suny At Stony Brook University Medical Center
City
Stony Brook
State/Province
New York
ZIP/Postal Code
11794
Country
United States
Facility Name
Univ. of North Carolina
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599-7220
Country
United States
Facility Name
Akron Children's Hospital
City
Akron
State/Province
Ohio
ZIP/Postal Code
44308
Country
United States
Facility Name
Children's Hospital of Oklahoma
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
Facility Name
Children's Hospital of Philadelphia
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Rhode Island Hospital
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02903
Country
United States
Facility Name
Children's Cardiology Associates PLLC
City
Austin
State/Province
Texas
ZIP/Postal Code
78756
Country
United States
Facility Name
Texas Children's Hospital
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
University of Virginia
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22908
Country
United States
Facility Name
Universitätsklinik für Kinder- und Jugendheilkunde
City
Innsbruck
ZIP/Postal Code
6020
Country
Austria
Facility Name
Allgemeines Krankenhaus Linz
City
Linz
ZIP/Postal Code
4020
Country
Austria
Facility Name
Universitätsklinik für Kinder- und Jugendheilkunde
City
Wein
Country
Austria
Facility Name
Ziekenhuisnetwerk Antwerpen - Koningin Paola Kinderziekenhuis
City
Antwerpen
ZIP/Postal Code
2020
Country
Belgium
Facility Name
UZ Brussel
City
Brussel,
ZIP/Postal Code
1090
Country
Belgium
Facility Name
UZ Brussel
City
Brussells
ZIP/Postal Code
1090
Country
Belgium
Facility Name
Hôpital Universitaire des Enfants Reine
City
Bruxelles
ZIP/Postal Code
1020
Country
Belgium
Facility Name
Cliniques Universitaires Saint-Luc
City
Bruxelles
ZIP/Postal Code
1200
Country
Belgium
Facility Name
UZ Antwerpen
City
Edegem,
ZIP/Postal Code
2650
Country
Belgium
Facility Name
UZ Antwerpen
City
Edegem
ZIP/Postal Code
2650
Country
Belgium
Facility Name
UZ Gent
City
Gent
Country
Belgium
Facility Name
UZ Leuven
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Facility Name
CHR de la Citadelle
City
Liège
ZIP/Postal Code
4000
Country
Belgium
Facility Name
University Multifunctional Hospital for Active Treatment
City
Pleven
Country
Bulgaria
Facility Name
University Mulitiprofile Hospital for Active Treatment "St.Georgi"
City
Plovdiv
ZIP/Postal Code
4002
Country
Bulgaria
Facility Name
Multifunctional Hospital for Active Treatment - Pleven
City
Plovdiv
Country
Bulgaria
Facility Name
Regional Dispensary for Pulmonary Diseases with Inpatient sector-Rousse
City
Rousse
Country
Bulgaria
Facility Name
Specialized Hospital for Active Treatment of Cardio-vascular Diseases
City
Sofia
Country
Bulgaria
Facility Name
Specialized Hospital for Active Treatment of Pediatric Diseases
City
Sofia
Country
Bulgaria
Facility Name
University Multifunctional Hospital for Active Treatment
City
Stara Zagora
Country
Bulgaria
Facility Name
Multifunctional Hospital for Active Treatment - Pleven
City
Varna
Country
Bulgaria
Facility Name
Children's and Women's Hospital of BC, Room #1R11
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V6H 3V4
Country
Canada
Facility Name
IWK Health Center
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3K 6R8
Country
Canada
Facility Name
The Hospital for Sick Children
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 1X8
Country
Canada
Facility Name
University of Alberta
City
Edmonton
Country
Canada
Facility Name
Montreal Children's Hospital
City
Montreal
Country
Canada
Facility Name
Saint Justine Hospital
City
Montreal
Country
Canada
Facility Name
Children's Hospital Of Eastern Ontario
City
Ottawa
ZIP/Postal Code
K1H 8L1
Country
Canada
Facility Name
Saskatchewan Drug Research Institute
City
Saskatoon SK
Country
Canada
Facility Name
Fakultni nemocnice Hradec Kralove
City
Hradec Kralove
ZIP/Postal Code
500 05
Country
Czech Republic
Facility Name
Nemocnice Most, prispevkova organizace
City
Most
ZIP/Postal Code
434 64
Country
Czech Republic
Facility Name
Fakultni nemocnice Plzen
City
Plzen - Lochotin
ZIP/Postal Code
304 60
Country
Czech Republic
Facility Name
Vseobecna fakultni nemocnice v Praze
City
Praha 2
ZIP/Postal Code
128 51
Country
Czech Republic
Facility Name
Ustav pro peci o matku a dite
City
Praha 4
ZIP/Postal Code
147 00
Country
Czech Republic
Facility Name
Fakultni nemocnice v Motole
City
Praha 5
ZIP/Postal Code
150 06
Country
Czech Republic
Facility Name
Fakultni nemocnice Na Bulovce
City
Praha 8
ZIP/Postal Code
180 81
Country
Czech Republic
Facility Name
Skejby Sygehus
City
Århus N
ZIP/Postal Code
DK-8200
Country
Denmark
Facility Name
Groupe Hospitalier Pelligrin
City
Bordeaux
ZIP/Postal Code
33076
Country
France
Facility Name
CHRU Dijon-Complex du Bocage
City
Dijon
ZIP/Postal Code
21034
Country
France
Facility Name
Centre chirurgical Marie Lannelongue
City
Le Plessis Robinson
ZIP/Postal Code
93250
Country
France
Facility Name
Hospital de la Conception
City
Marseille
ZIP/Postal Code
13385
Country
France
Facility Name
Hospital Robert Debre
City
Paris
ZIP/Postal Code
75019
Country
France
Facility Name
American Memorial Hospital
City
Reims
ZIP/Postal Code
51092
Country
France
Facility Name
Hospital de Hautepierre
City
Strasbourg
ZIP/Postal Code
67098
Country
France
Facility Name
Hospitaux de Brabois
City
Vandoeuvre les Nancy
ZIP/Postal Code
54511
Country
France
Facility Name
Herz- und Diabeteszentrum NRW
City
Bad Oeynhausen
ZIP/Postal Code
32545
Country
Germany
Facility Name
Friedrich-Alexander-Universiät Erlangen Nürnberg
City
Freiburg
ZIP/Postal Code
79106
Country
Germany
Facility Name
Medizinische Hochschule Hannover
City
Hanover
ZIP/Postal Code
36023
Country
Germany
Facility Name
Universitätsklinikum Schleswig Holstein
City
Kiel
ZIP/Postal Code
24105
Country
Germany
Facility Name
Johannes Gutenberg-Universität
City
Mainz
ZIP/Postal Code
55105
Country
Germany
Facility Name
LMU Klinikum der Universität
City
München
ZIP/Postal Code
81377
Country
Germany
Facility Name
Klinikum Oldenburg
City
Oldenburg
ZIP/Postal Code
26133
Country
Germany
Facility Name
Universitätsklinik Rostock
City
Rostock
ZIP/Postal Code
18055
Country
Germany
Facility Name
Universitätsklinik Rostock
City
Rostock
ZIP/Postal Code
26133
Country
Germany
Facility Name
Universitätsklinikum Tübingen
City
Tübingen
ZIP/Postal Code
72076
Country
Germany
Facility Name
Semmelweis Egyetem
City
Budapest
ZIP/Postal Code
H-1083
Country
Hungary
Facility Name
Gottsegen Gyorgy Orszagos Kardiologiai Intezet, Gyermeksziv Kozpont
City
Budapest
ZIP/Postal Code
H-1096
Country
Hungary
Facility Name
Debreceni Egyetem OEC
City
Debrecen
ZIP/Postal Code
H-4012
Country
Hungary
Facility Name
Petz Aladar Megyei Korhaz
City
Gyor
ZIP/Postal Code
9023
Country
Hungary
Facility Name
Borsod-Abaúj-Zemplén Megyei Kórház és Egyetemi Oktató Kórház
City
Miskolc
ZIP/Postal Code
H-3526
Country
Hungary
Facility Name
Josa Andras Korhaz
City
Nyiregyhaza
ZIP/Postal Code
H-4400
Country
Hungary
Facility Name
Pecsi Tudomanyegyetem
City
Pecs
ZIP/Postal Code
H-7623
Country
Hungary
Facility Name
Szegedi Tudomanyegyetem AOK, Gyermekgyogyaszati Klinika
City
Szeged
ZIP/Postal Code
H-6720
Country
Hungary
Facility Name
Veszprém Megyei Önkormányzat - Csolnoky Ferenc Kórház
City
Veszprem
ZIP/Postal Code
H-8200
Country
Hungary
Facility Name
Soroka University Medical Center
City
Beer Sheva
ZIP/Postal Code
84101
Country
Israel
Facility Name
Rambam Medical Center
City
Haifa
ZIP/Postal Code
31096
Country
Israel
Facility Name
Edith Wolfson Medical Center
City
Holon
ZIP/Postal Code
58100
Country
Israel
Facility Name
Shaare Zedek Medical Center
City
Jerusalem
ZIP/Postal Code
91031
Country
Israel
Facility Name
Hadassah University Hospital Ein Kerem
City
Jerusalem
ZIP/Postal Code
91120
Country
Israel
Facility Name
Schneider Children's Medical Center of Israel
City
Petach Tikva
ZIP/Postal Code
49100
Country
Israel
Facility Name
The Chaim Sheba Medical Center
City
Ramat-Gan
ZIP/Postal Code
52621
Country
Israel
Facility Name
Tel-Aviv Sourasky Medical Center
City
Tel Aviv
ZIP/Postal Code
64239
Country
Israel
Facility Name
The Chaim Sheba Medical Center
City
Tel Hashomer
ZIP/Postal Code
52621
Country
Israel
Facility Name
St George University Hospital
City
Achrafieh- Beirut
Country
Lebanon
Facility Name
American University of Beirut Medical Center
City
Beirut
ZIP/Postal Code
113-6044
Country
Lebanon
Facility Name
Hotel Dieu De France
City
Beirut
Country
Lebanon
Facility Name
Samodzielny Publiczny Szpital Akademii Medycznej
City
Bialystok
ZIP/Postal Code
15-276
Country
Poland
Facility Name
Samodzielny Publiczny Zaklad Opieki Zdrowotnej, Wojewodzki Szpital im. dr Jana Biziela w Bydgoszczy
City
Bydgoszcz
ZIP/Postal Code
85-168
Country
Poland
Facility Name
Wojewodzki Szpital Dzieciecy W Bydgoszczy
City
Bydgoszcz
ZIP/Postal Code
85-667
Country
Poland
Facility Name
Instytut Centrum Zdrowia Matki Polki
City
Lodz
ZIP/Postal Code
93-338
Country
Poland
Facility Name
Dzieciecy Szpital Kliniczny im. Prof. Antoniego Gebal Poliklinika
City
Lubin
ZIP/Postal Code
20-093
Country
Poland
Facility Name
Ginekologiczno-Poloznicy Szpital Kliniczny Uniwersytetu Medycznego w Poznaniu
City
Poznan
ZIP/Postal Code
60-535
Country
Poland
Facility Name
Szpital Kliniczny Uniwersytetu Medycznego im. Karola Jonschera
City
Poznan
ZIP/Postal Code
60-572
Country
Poland
Facility Name
Samodzielny Publiczny Szpital Kliniczny nr 1 im. Tadeusza Sokolowskiego Pomorskiej AM w Szczecinie
City
Szczecin
ZIP/Postal Code
71-252
Country
Poland
Facility Name
Instytut "Pomnik - Centrum Zdrowia Dziecka"
City
Warszawa
ZIP/Postal Code
04-736
Country
Poland
Facility Name
Kazan State Medical University
City
Kazan
Country
Russian Federation
Facility Name
Kuban State Medical Academy
City
Krasnodar
ZIP/Postal Code
350086
Country
Russian Federation
Facility Name
Meshalkin Research Institue of Blood circulation
City
Novosibirsk
ZIP/Postal Code
630055
Country
Russian Federation
Facility Name
City Outpatient Clinic #113
City
St. Petersburg
ZIP/Postal Code
193312
Country
Russian Federation
Facility Name
Saint Petersburg State Pediatric Medical Academy
City
St. Petersburg
ZIP/Postal Code
194100
Country
Russian Federation
Facility Name
St. Petersburg City Children's Hospital #1
City
St. Petersburg
ZIP/Postal Code
198205
Country
Russian Federation
Facility Name
Research Cardiology Institute of Tomsk Scientific Center
City
Tomsk
ZIP/Postal Code
634012
Country
Russian Federation
Facility Name
St. Petersburg Pediatric city hospital
City
Tyumen
ZIP/Postal Code
625000
Country
Russian Federation
Facility Name
Hospital de Cruces
City
Barakaldo
ZIP/Postal Code
48903
Country
Spain
Facility Name
Hospital Vall d'Hebron
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
Hospital Reina Sofia
City
Córdoba
ZIP/Postal Code
14004
Country
Spain
Facility Name
Hospital Universitario Virgen de la Arrixaca
City
El Palmar
ZIP/Postal Code
30120
Country
Spain
Facility Name
Hospital Sant Joan de Deu
City
Esplugas de Llobregat
ZIP/Postal Code
08950
Country
Spain
Facility Name
Hospital Josep Trueta
City
Girona
ZIP/Postal Code
17007
Country
Spain
Facility Name
Hospital Universitario Virgen de Las Nieves
City
Granada
ZIP/Postal Code
18014
Country
Spain
Facility Name
Hospital Materno Infantil de Jaen
City
Jaen
ZIP/Postal Code
23007
Country
Spain
Facility Name
Hospital de Jerez
City
Jerez de la Frontera
ZIP/Postal Code
11407
Country
Spain
Facility Name
Hospital Juan Canalejo
City
La Coruña
ZIP/Postal Code
15006
Country
Spain
Facility Name
Hospital Gregorio Marañon
City
Madrid
ZIP/Postal Code
28009
Country
Spain
Facility Name
Hospital La Paz
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Facility Name
Hospital 12 de Octubre
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Facility Name
Hospital Materno Infantil
City
Málaga
ZIP/Postal Code
29011
Country
Spain
Facility Name
Hospital Donostia
City
San Sebastian
ZIP/Postal Code
20014
Country
Spain
Facility Name
Hospital Infantil Universitario Virgen del Rocío
City
Sevilla
ZIP/Postal Code
41013
Country
Spain
Facility Name
Hospital Xeral de Vigo
City
Vigo
ZIP/Postal Code
36204
Country
Spain
Facility Name
Hospital Universitario Miguel Servet
City
Zaragoza
ZIP/Postal Code
5009
Country
Spain
Facility Name
Jan Sunnegardh's- Private Practice
City
Göteborg
ZIP/Postal Code
SE-41685
Country
Sweden
Facility Name
Universitetssjukhuset i Lund
City
Lund
Country
Sweden
Facility Name
Karolinska University Hospital
City
Stockholm
ZIP/Postal Code
SE-17176
Country
Sweden
Facility Name
Akademiska Sjukhuset i Uppsala
City
Uppsala
ZIP/Postal Code
95 NVB
Country
Sweden
Facility Name
Universitetssjukhuset i Lund
City
Uppsala
ZIP/Postal Code
95 NVB
Country
Sweden
Facility Name
Royal Belfast Hospital for Sick Children
City
Belfast
ZIP/Postal Code
BT 12 6BE
Country
United Kingdom
Facility Name
Bristol Royal Hospital for Children
City
Bristol
ZIP/Postal Code
BS2 8BJ
Country
United Kingdom
Facility Name
Medway Maritime Hospital
City
Gillingham
ZIP/Postal Code
ME7 5NY
Country
United Kingdom
Facility Name
Leeds General Infirmary
City
Leeds
ZIP/Postal Code
LS1 3EX
Country
United Kingdom
Facility Name
University Hospitals of Leicester NHS Trust
City
Leicester
ZIP/Postal Code
LE3 9QP
Country
United Kingdom
Facility Name
Royal Brompton Hospital
City
London
ZIP/Postal Code
SW3 6NP
Country
United Kingdom
Facility Name
Southampton General Hospital
City
Southampton
ZIP/Postal Code
SO16 6YD
Country
United Kingdom

12. IPD Sharing Statement

Learn more about this trial

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

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