- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01075178
Retrospective Palivizumab Study in Children With Hemodynamically Significant Congenital Heart Disease
March 18, 2011 updated by: Abbott
Palivizumab (Synagis®) Post-marketing Surveillance Cohort Study in Children < 24 Months of Age With Hemodynamically Significant Congenital Heart Disease
Retrospective medical record review study of specific adverse events in children with congenital heart disease who received palivizumab for prophylaxis of serious respiratory syncytial virus infection and control subjects that did not receive palivizumab
Study Overview
Status
Completed
Conditions
Detailed Description
This is an observational, non-interventional, retrospective cohort study of infants with hemodynamically significant congenital heart disease (HSCHD) who were less than 24 months of age when the first dose of palivizumab was administered (CASES), and infants who were diagnosed with hemodynamically significant congenital heart disease but did not receive palivizumab in a historical respiratory syncytial virus (RSV) season during the first 24 months of life (CONTROLS).
CASES are matched to CONTROLS based on RSV season, age, type of cardiac lesion, and type of prior corrective cardiac surgery.
Subject medical records are reviewed for occurrences of the clinical end points of infection, arrhythmia, and/or death that meet criteria for serious adverse events.
The groups will be compared for number and percent of subjects who experience these primary serious adverse events (both individually and collectively) during a defined 8-month chart review period.
Study Type
Observational
Enrollment (Actual)
2036
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Linz, Austria, 4020
- Site Reference ID/Investigator# 6263
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Vienna, Austria, 1090
- Site Reference ID/Investigator# 7956
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Vienna, Austria, 1100
- Site Reference ID/Investigator# 9403
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Brussels, Belgium, 1200
- Site Reference ID/Investigator# 17821
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Gent, Belgium, 9000
- Site Reference ID/Investigator# 18602
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Leuven, Belgium, 3000
- Site Reference ID/Investigator# 18601
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Nantes, France, 44093
- Site Reference ID/Investigator# 6244
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Paris, France, 75019
- Site Reference ID/Investigator# 6261
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Paris, France, CEDEX 15
- Site Reference ID/Investigator# 6245
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Reims, France, 51092
- Site Reference ID/Investigator#6260
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Bad Oeynhausen, Germany, 32545
- Site Reference ID/Investigator# 6280
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Berlin, Germany, 10779
- Site Reference ID/Investigator# 9621
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Braunschweig, Germany, 38102
- Site Reference ID/Investigator# 16361
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Duisburg, Germany, 47137
- Site Reference ID/Investigator# 6283
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Essen, Germany, 45147
- Site Reference ID/Investigator# 6272
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Goettingen, Germany, 37075
- Site Reference ID/Investigator# 6271
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Munich, Germany, 81377
- Site Reference ID/Investigator# 8277
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Rostock, Germany, 18057
- Site Reference ID/Investigator# 11182
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St. Augustin, Germany, 53757
- Site Reference ID/Investigator# 6249
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Campobasso, Italy, 86100
- Site Reference ID/Investigator# 6274
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Florence, Italy, 50139
- Site Reference ID/Investigator# 6276
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Naples, Italy, 80100
- Site Reference ID/Investigator# 4703
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Padova, Italy, 35128
- Site Reference ID/Investigator# 4910
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Roma, Italy, 00165
- Site Reference ID/Investigator# 14681
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Trondheim, Norway, 7006
- Site Reference ID/Investigator# 14802
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Bydgoszcz, Poland, 85-168
- Site Reference ID/Investigator# 6275
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Katowice, Poland, 40-752
- Site Reference ID/Investigator# 13102
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Krakow, Poland, 3-663
- Site Reference ID/Investigator# 6270
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Warsaw, Poland, 04-730
- Site Reference ID/Investigator# 12222
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Ljubljana, Slovenia, 1525
- Site Reference ID/Investigator# 14682
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A Coruna, Spain, 15006
- Site Reference ID/Investigator# 5372
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Madrid, Spain, 28009
- Site Reference ID/Investigator# 15381
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Madrid, Spain, 28034
- Site Reference ID/Investigator# 15702
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Santiago de Compostela, Spain, 15706
- Site Reference ID/Investigator# 15261
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Belfast, United Kingdom, BT12 6BE
- Site Reference ID/Investigator# 6282
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Bristol, United Kingdom, BS2 8BJ
- Site Reference ID/Investigator# 13941
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London, United Kingdom, SW3 6NP
- Site Reference ID/Investigator# 5023
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
No older than 2 years (CHILD)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Children less than 24 months of age with hemodynamically significant congenital heart disease
Description
Inclusion Criteria:
- Subject must have documented hemodynamically significant congenital heart disease (Note: Children with uncomplicated small atrial or ventricular septal defects or patent ductus arteriosus are not eligible).
- Subject must have unoperated or partially corrected congenital heart disease.
- Subject must have received at least one dose of palivizumab for prophylaxis during the Respiratory Syncytial Virus season - September 1 through April 30 (CASES), or would have been considered eligible for palivizumab prophylaxis (CONTROLS).
- Subject must be < 24 months of age at the time of the first dose of palivizumab prophylaxis (CASES) or < 32 months of age at the end of the assigned Respiratory Syncytial Virus season in which they would have been eligible to receive palivizumab if the drug had been approved in the European Union (CONTROLS).
- Subject's parent, guardian, or legal representative has voluntarily signed and dated a Release of Information Form to allow the review of medical records and collection of pertinent study data.
Exclusion Criteria:
- Subject was contraindicated for treatment with palivizumab according to the current European product label.
- Subject had full correction of Congenital Heart Disease.
- Subject received palivizumab before approval for use in Congenital Heart Disease (CASES), or subject received palivizumab at any time (CONTROLS).
- Subject has already been included in this study in a prior Respiratory Syncytial Virus season.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Palivizumab-treated subjects (CASES)
HSCHD infants, <2 yrs old at first dose of palivizumab
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Non-palivizumab-treated subjects (CONTROLS)
HSCHD infants, <2 yrs old that did not receive palivizumab
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Comparison Between CASES and CONTROLS of the Occurrence of Specific Clinical Outcomes of Serious Infection, Serious Arrhythmia and/or Death
Time Frame: 8-month chart review period in CASES and CONTROLS
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The number of subjects who experienced at least 1 event of infection, arrhythmia, or death meeting any of the criteria for a serious adverse event
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8-month chart review period in CASES and CONTROLS
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Comparison Between CASES and CONTROLS of the Occurrence of Specific Clinical Outcomes of Serious Infection.
Time Frame: 8-month chart review period in CASES and CONTROLS
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The number of subjects who experienced at least 1 event of infection meeting any of the criteria for a serious adverse event
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8-month chart review period in CASES and CONTROLS
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Comparison Between CASES and CONTROLS of the Occurrence of Specific Clinical Outcomes of Serious Arrhythmia
Time Frame: 8-month chart review period in CASES and CONTROLS
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The number of subjects who experienced at least 1 event of arrhythmia meeting any of the criteria for a serious adverse event
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8-month chart review period in CASES and CONTROLS
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Comparison Between CASES and CONTROLS of the Occurrence of Specific Clinical Outcomes of Death
Time Frame: 8-month chart review period in CASES and CONTROLS
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The number of subjects who died
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8-month chart review period in CASES and CONTROLS
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Andrew Campbell, MD, Medical Director, Abbott Laboratories
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2006
Primary Completion (ACTUAL)
January 1, 2010
Study Completion (ACTUAL)
January 1, 2010
Study Registration Dates
First Submitted
February 23, 2010
First Submitted That Met QC Criteria
February 23, 2010
First Posted (ESTIMATE)
February 25, 2010
Study Record Updates
Last Update Posted (ESTIMATE)
March 23, 2011
Last Update Submitted That Met QC Criteria
March 18, 2011
Last Verified
March 1, 2011
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- M03-681
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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