Ignite Creation Date:
2025-12-24 @ 6:50 PM
Ignite Modification Date:
2026-02-12 @ 9:55 PM
Study NCT ID:
NCT00486057
Status:
TERMINATED
Last Update Posted:
2011-11-21
First Post:
2007-06-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Daclizumab Experience in Pediatric Heart Transplant
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D012059', 'term': 'Rejection, Psychology'}], 'ancestors': [{'id': 'D012919', 'term': 'Social Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'whyStopped': 'sufficient data collected for conclusion of retrospective study', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2004-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2007-11', 'completionDateStruct': {'date': '2007-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-11-18', 'studyFirstSubmitDate': '2007-06-12', 'studyFirstSubmitQcDate': '2007-06-12', 'lastUpdatePostDateStruct': {'date': '2011-11-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-06-13', 'type': 'ESTIMATED'}}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Daclizumab', 'Immuno-suppression protocol', 'Heart Transplant', 'Rejection'], 'conditions': ['Congenital Disorders']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to examine the outcomes of those who have received Daclizumab as part of their immuno-suppression protocol following heart transplantation. Literature suggests that the time to first rejection episode can be avoided or delayed by using induction therapy.', 'detailedDescription': "In August 2005 the heart transplant team at Children's Healthcare of Atlanta began a protocol of Daclizumab 1mg/kg IV every two weeks for 5 doses; 1st dose to be received in the operating room following discontinuation of cardiopulmonary bypass.\n\nSince one year has passed following initiation of this practice, it is necessary to review this immuno-suppression strategy and determine if, in fact, there was clinical benefit of reducing rejection without increasing the vulnerabilities of the immuno-compromised host.\n\nWe wish to review all heart transplant recipient records between August 1, 2004 and October 15, 2006. Historically, Children's has done approximately 10 transplants per year; therefore, we will review approximately 15 charts at Children's Healthcare of Atlanta and Sibley Heart Center Cardiology."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '21 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Status post heart transplant Age 0-21 years Received Daclizumab as induction therapy', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Status post heart transplant\n* Age 0-21 years\n* Received Daclizumab as induction therapy\n\nExclusion Criteria:\n\n* Those who do not meet inclusion criteria'}, 'identificationModule': {'nctId': 'NCT00486057', 'briefTitle': 'Daclizumab Experience in Pediatric Heart Transplant', 'organization': {'class': 'OTHER', 'fullName': "Children's Healthcare of Atlanta"}, 'officialTitle': 'A Retrospective Review of Daclizumab Experience in Pediatric Heart Transplant', 'orgStudyIdInfo': {'id': '06-199'}}, 'contactsLocationsModule': {'locations': [{'zip': '30322', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': "Children's Healthcare of Atlanta", 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}], 'overallOfficials': [{'name': 'Kirk R Kanter, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Children's Healthcare of Atlanta, Pediatric Surgery"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Children's Healthcare of Atlanta", 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Director Research', 'oldOrganization': "Children's Healthcare of Atlanta Institutional Review Board"}}}}