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Congenital Heart DiseasePhase 2NCT00538785

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

A Phase 2 study testing Motavizumab and Palivizumab in people with Congenital Heart Disease, run by MedImmune LLC at 152 sites in 17 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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. Read more about this study

Who is it for?
Ages Up to 24 months
Conditions the study is for
Congenital Heart Disease
What is being tested?
Motavizumab and Palivizumab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,236 participants
Where
152 sitesin 17 countries
Study dates
Oct 2005to Jun 2008
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Up to 24 months
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • 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.

Who cannot join

  • 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
Show all 15Show fewer
  • 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)

Trial locations and contacts

152 sites in 17 countries.

152 sites in 17 countries

United States30 sites

  • Akron Children's Hospital

    Akron, Ohio, 44308

  • Children's Cardiology Associates PLLC

    Austin, Texas, 78756

  • University of Maryland

    Baltimore, Maryland, 21201

  • Johns Hopkins Hospital

    Baltimore, Maryland, 21287

  • Tufts - New England Medical Center

    Boston, Massachusetts, 02111

  • Children's Hospital Boston

    Boston, Massachusetts, 02115

  • Univ. of North Carolina

    Chapel Hill, North Carolina, 27599-7220

  • University of Virginia

    Charlottesville, Virginia, 22908

  • Children's Hospital of Michigan

    Detroit, Michigan, 48201

  • Texas Children's Hospital

    Houston, Texas, 77030

  • James Whitcomb Riley Hospital for Children

    Indianapolis, Indiana, 46202

  • Children's Mercy Hospital

    Kansas City, Missouri, 64108

  • Arkansas Pediatric Clinic

    Little Rock, Arkansas, 72205

  • Miller Children's Hospital

    Long Beach, California, 90806

  • Childrens Hospital Los Angeles

    Los Angeles, California, 90027

  • Yale New Haven Children's Hospital

    New Haven, Connecticut, 06520-8064

  • Tulane University Health Sciences Center

    New Orleans, Louisiana, 70112

  • Children's Hospital and Research Center at Oakland

    Oakland, California, 94609

  • Children's Hospital of Oklahoma

    Oklahoma City, Oklahoma, 73104

  • Nemours Children's Clinic Biomedical Research Department

    Orlando, Florida, 32801

  • Children's Hospital of Philadelphia

    Philadelphia, Pennsylvania, 19104

  • Rhode Island Hospital

    Providence, Rhode Island, 02903

  • Mayo Clinic

    Rochester, Minnesota, 55905

  • University of Rochester

    Rochester, New York, 14642

  • University of California Davis Medical Center

    Sacramento, California, 95817

  • Children's Hospital And Health Center

    San Diego, California, 92123

  • Memorial Hospital of South Bend

    South Bend, Indiana, 46601

  • Washington University School of Medicine

    St Louis, Missouri, 63110

  • Suny At Stony Brook University Medical Center

    Stony Brook, New York, 11794

  • Children's National Medical Center

    Washington D.C., District of Columbia, 20010

Other trials in United States

Spain18 sites

  • Hospital Juan Canalejo

    A Coruña, 15006

  • Hospital de Cruces

    Barakaldo, 48903

  • Hospital Vall d'Hebron

    Barcelona, 08035

  • Hospital Reina Sofia

    Córdoba, 14004

  • Hospital Donostia

    Donostia / San Sebastian, 20014

  • Hospital Universitario Virgen de la Arrixaca

    El Palmar, 30120

  • Hospital Sant Joan de Deu

    Esplugas de Llobregat, 08950

  • Hospital Josep Trueta

    Girona, 17007

  • Hospital Universitario Virgen de Las Nieves

    Granada, 18014

  • Hospital Materno Infantil de Jaen

    Jaén, 23007

  • Hospital de Jerez

    Jerez de la Frontera, 11407

  • Hospital Gregorio Marañon

    Madrid, 28009

  • Hospital La Paz

    Madrid, 28040

  • Hospital 12 de Octubre

    Madrid, 28041

  • Hospital Materno Infantil

    Málaga, 29011

  • Hospital Infantil Universitario Virgen del Rocío

    Seville, 41013

  • Hospital Xeral de Vigo

    Vigo, 36204

  • Hospital Universitario Miguel Servet

    Zaragoza, 5009

Other trials in Spain

Germany10 sites

  • Herz- und Diabeteszentrum NRW

    Bad Oeynhausen, 32545

  • Friedrich-Alexander-Universiät Erlangen Nürnberg

    Freiburg im Breisgau, 79106

  • Medizinische Hochschule Hannover

    Hanover, 36023

  • Universitätsklinikum Schleswig Holstein

    Kiel, 24105

  • Johannes Gutenberg-Universität

    Mainz, 55105

  • LMU Klinikum der Universität

    München, 81377

  • Klinikum Oldenburg

    Oldenburg, 26133

  • Universitätsklinik Rostock

    Rostock, 18055

  • Universitätsklinik Rostock

    Rostock, 26133

  • Universitätsklinikum Tübingen

    Tübingen, 72076

Other trials in Germany

Belgium9 sites

  • Ziekenhuisnetwerk Antwerpen - Koningin Paola Kinderziekenhuis

    Antwerp, 2020

  • UZ Brussel

    Brussells, 1090

  • Hôpital Universitaire des Enfants Reine

    Brussels, 1020

  • UZ Brussel

    Brussels, 1090

  • Cliniques Universitaires Saint-Luc

    Brussels, 1200

  • UZ Antwerpen

    Edegem, 2650

  • UZ Gent

    Ghent

  • UZ Leuven

    Leuven, 3000

  • CHR de la Citadelle

    Liège, 4000

Other trials in Belgium

Hungary9 sites

  • Semmelweis Egyetem

    Budapest, H-1083

  • Gottsegen Gyorgy Orszagos Kardiologiai Intezet, Gyermeksziv Kozpont

    Budapest, H-1096

  • Debreceni Egyetem OEC

    Debrecen, H-4012

  • Petz Aladar Megyei Korhaz

    Győr, 9023

  • Borsod-Abaúj-Zemplén Megyei Kórház és Egyetemi Oktató Kórház

    Miskolc, H-3526

  • Josa Andras Korhaz

    Nyíregyháza, H-4400

  • Pecsi Tudomanyegyetem

    Pécs, H-7623

  • Szegedi Tudomanyegyetem AOK, Gyermekgyogyaszati Klinika

    Szeged, H-6720

  • Veszprém Megyei Önkormányzat - Csolnoky Ferenc Kórház

    Veszprém, H-8200

Other trials in Hungary

Israel9 sites

  • Soroka University Medical Center

    Beersheba, 84101

  • Rambam Medical Center

    Haifa, 31096

  • Edith Wolfson Medical Center

    Holon, 58100

  • Shaare Zedek Medical Center

    Jerusalem, 91031

  • Hadassah University Hospital Ein Kerem

    Jerusalem, 91120

  • Schneider Children's Medical Center of Israel

    Petah Tikva, 49100

  • The Chaim Sheba Medical Center

    Ramat Gan, 52621

  • Tel-Aviv Sourasky Medical Center

    Tel Aviv, 64239

  • The Chaim Sheba Medical Center

    Tel HaShomer, 52621

Other trials in Israel

Poland9 sites

  • Samodzielny Publiczny Szpital Akademii Medycznej

    Bialystok, 15-276

  • Samodzielny Publiczny Zaklad Opieki Zdrowotnej, Wojewodzki Szpital im. dr Jana Biziela w Bydgoszczy

    Bydgoszcz, 85-168

  • Wojewodzki Szpital Dzieciecy W Bydgoszczy

    Bydgoszcz, 85-667

  • Instytut Centrum Zdrowia Matki Polki

    Lodz, 93-338

  • Dzieciecy Szpital Kliniczny im. Prof. Antoniego Gebal Poliklinika

    Lubin, 20-093

  • Ginekologiczno-Poloznicy Szpital Kliniczny Uniwersytetu Medycznego w Poznaniu

    Poznan, 60-535

  • Szpital Kliniczny Uniwersytetu Medycznego im. Karola Jonschera

    Poznan, 60-572

  • Samodzielny Publiczny Szpital Kliniczny nr 1 im. Tadeusza Sokolowskiego Pomorskiej AM w Szczecinie

    Szczecin, 71-252

  • Instytut "Pomnik - Centrum Zdrowia Dziecka"

    Warsaw, 04-736

Other trials in Poland

Bulgaria8 sites

  • University Multifunctional Hospital for Active Treatment

    Pleven

  • University Mulitiprofile Hospital for Active Treatment "St.Georgi"

    Plovdiv, 4002

  • Multifunctional Hospital for Active Treatment - Pleven

    Plovdiv

  • Regional Dispensary for Pulmonary Diseases with Inpatient sector-Rousse

    Rousse

  • Specialized Hospital for Active Treatment of Cardio-vascular Diseases

    Sofia

  • Specialized Hospital for Active Treatment of Pediatric Diseases

    Sofia

  • University Multifunctional Hospital for Active Treatment

    Stara Zagora

  • Multifunctional Hospital for Active Treatment - Pleven

    Varna

Other trials in Bulgaria

Canada8 sites

  • University of Alberta

    Edmonton

  • IWK Health Center

    Halifax, Nova Scotia, B3K 6R8

  • Montreal Children's Hospital

    Montreal

  • Saint Justine Hospital

    Montreal

  • Children's Hospital Of Eastern Ontario

    Ottawa, K1H 8L1

  • Saskatchewan Drug Research Institute

    Saskatoon SK

  • The Hospital for Sick Children

    Toronto, Ontario, M5G 1X8

  • Children's and Women's Hospital of BC, Room #1R11

    Vancouver, British Columbia, V6H 3V4

Other trials in Canada

France8 sites

  • Groupe Hospitalier Pelligrin

    Bordeaux, 33076

  • CHRU Dijon-Complex du Bocage

    Dijon, 21034

  • Centre chirurgical Marie Lannelongue

    Le Plessis-Robinson, 93250

  • Hospital de la Conception

    Marseille, 13385

  • Hospital Robert Debre

    Paris, 75019

  • American Memorial Hospital

    Reims, 51092

  • Hospital de Hautepierre

    Strasbourg, 67098

  • Hospitaux de Brabois

    Vandœuvre-lès-Nancy, 54511

Other trials in France

Russia8 sites

  • Kazan State Medical University

    Kazan'

  • Kuban State Medical Academy

    Krasnodar, 350086

  • Meshalkin Research Institue of Blood circulation

    Novosibirsk, 630055

  • City Outpatient Clinic #113

    Saint Petersburg, 193312

  • Saint Petersburg State Pediatric Medical Academy

    Saint Petersburg, 194100

  • St. Petersburg City Children's Hospital #1

    Saint Petersburg, 198205

  • Research Cardiology Institute of Tomsk Scientific Center

    Tomsk, 634012

  • St. Petersburg Pediatric city hospital

    Tyumen, 625000

Other trials in Russia

Czechia7 sites

  • Fakultni nemocnice Hradec Kralove

    Hradec Králové, 500 05

  • Nemocnice Most, prispevkova organizace

    Most, 434 64

  • Fakultni nemocnice Plzen

    Plzen - Lochotin, 304 60

  • Vseobecna fakultni nemocnice v Praze

    Prague, 128 51

  • Ustav pro peci o matku a dite

    Prague, 147 00

  • Fakultni nemocnice v Motole

    Prague, 150 06

  • Fakultni nemocnice Na Bulovce

    Prague, 180 81

Other trials in Czechia

United Kingdom7 sites

  • Royal Belfast Hospital for Sick Children

    Belfast, BT 12 6BE

  • Bristol Royal Hospital for Children

    Bristol, BS2 8BJ

  • Medway Maritime Hospital

    Gillingham, ME7 5NY

  • Leeds General Infirmary

    Leeds, LS1 3EX

  • University Hospitals of Leicester NHS Trust

    Leicester, LE3 9QP

  • Royal Brompton Hospital

    London, SW3 6NP

  • Southampton General Hospital

    Southampton, SO16 6YD

Other trials in United Kingdom

Sweden5 sites

  • Jan Sunnegardh's- Private Practice

    Gothenburg, SE-41685

  • Universitetssjukhuset i Lund

    Lund

  • Karolinska University Hospital

    Stockholm, SE-17176

  • Akademiska Sjukhuset i Uppsala

    Uppsala, 95 NVB

  • Universitetssjukhuset i Lund

    Uppsala, 95 NVB

Other trials in Sweden

Austria3 sites

  • Universitätsklinik für Kinder- und Jugendheilkunde

    Innsbruck, 6020

  • Allgemeines Krankenhaus Linz

    Linz, 4020

  • Universitätsklinik für Kinder- und Jugendheilkunde

    Wein

Other trials in Austria

Lebanon3 sites

  • St George University Hospital

    Achrafieh- Beirut

  • American University of Beirut Medical Center

    Beirut, 113-6044

  • Hotel Dieu De France

    Beirut

Other trials in Lebanon

Denmark1 site

  • Skejby Sygehus

    Århus N, DK-8200

Other trials in Denmark

About this study

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

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.

Read the 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.

Being tested
Motavizumab, Palivizumab
Keywords
Synagis, motavizumab, palivizumab, children, MEDI-524, RSV, congenital hear disease
Medical subject headings
Heart Defects, Congenital

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MotavizumabBiological

    Also called Medi-524

    15 mg/kg IM administered at monthly intervals

  • PalivizumabBiological

    Also called Synagis

    15 mg/kg IM administered at monthly intervals

Study groups in NCT00538785
Study groupRoleWhat they receive
MotavizumabExperimentalMotavizumab 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.
Receives: Biological: Motavizumab
PailvizumabActive comparatorPalivizumab 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.
Receives: Biological: Palivizumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Days 0-150

  2. 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.

    Measured: Days 0-150

  3. Number of Subjects Reporting Laboratory Adverse Events

    Measured: Days 0-150

Secondary outcomes (9)

  1. 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).

    Measured: Days 0-150

  2. 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.

    Measured: Days 0-150

  3. Number of Subjects Who Had Anti-motavizumab Antibodies Detected

    ECLA-based method

    Measured: Days 0-150

  4. Mean Trough Serum Concentration of Motavizumab at Pre-dose 1

    Trough serum concentrations (ug/mL) of motavizumab at pre-dose 1

    Measured: Pre-dose 1

  5. 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

    Measured: 30 days post-dose 1

  6. 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

    Measured: 30 days post-dose 2

  7. 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

    Measured: 30 days post-dose 3

  8. 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

    Measured: 30 days post-dose 4

  9. 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.

    Measured: Days 0-150

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Oct 2007 (estimated)
  2. Study startOct 2005
  3. Primary completionJun 2008
  4. Study completionJun 2008

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
1,236 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00538785
Sponsor's protocol ID
MI-CP124-S2
Status last verified
Feb 2012
First submitted
1 Oct 2007
Last updated
16 Feb 2012
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Motavizumab and Palivizumab in people with Congenital Heart Disease, run by MedImmune LLC at 152 sites in 17 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Feb 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 152 sites in United States, Spain, Germany, Belgium, Hungary and 12 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 14 Feb 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Subjects Reporting Adverse Events Through Study Day 150 (time frame: Days 0-150). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00538785.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Feb 2012.

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