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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00538785
Other study ID # MI-CP124-S2
Secondary ID
Status Completed
Phase Phase 2
First received October 1, 2007
Last updated February 14, 2012
Start date October 2005
Est. completion date June 2008

Study information

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

Clinical Trial 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.


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.


Other known NCT identifiers
  • NCT00240890

Recruitment information / eligibility

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)

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention


Intervention

Biological:
Motavizumab
15 mg/kg IM administered at monthly intervals
Palivizumab
15 mg/kg IM administered at monthly intervals

Locations

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

Sponsors (1)

Lead Sponsor Collaborator
MedImmune LLC

Countries where clinical trial is conducted

United States,  Austria,  Belgium,  Bulgaria,  Canada,  Czech Republic,  Denmark,  France,  Germany,  Hungary,  Israel,  Lebanon,  Poland,  Russian Federation,  Spain,  Sweden,  United Kingdom, 

Outcome

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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