- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00486057
Daclizumab Experience in Pediatric Heart Transplant
A Retrospective Review of Daclizumab Experience in Pediatric Heart Transplant
Study Overview
Status
Conditions
Detailed Description
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.
Since 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.
We 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.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Georgia
-
Atlanta, Georgia, United States, 30322
- Children's Healthcare of Atlanta
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Status post heart transplant
- Age 0-21 years
- Received Daclizumab as induction therapy
Exclusion Criteria:
- Those who do not meet inclusion criteria
Study Plan
How is the study designed?
Design Details
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Kirk R Kanter, MD, Children's Healthcare of Atlanta, Pediatric Surgery
Study record dates
Study Major Dates
Study Start
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 06-199
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.
Clinical Trials on Congenital Disorders
-
University College London HospitalsRecruiting
-
Children's Healthcare of AtlantaCompletedCongenital DisordersUnited States
-
Children's Healthcare of AtlantaCompleted
-
Children's Healthcare of AtlantaTerminatedCongenital DisordersUnited States
-
Children's Healthcare of AtlantaTerminated
-
Children's Healthcare of AtlantaTerminated
-
Children's Healthcare of AtlantaTerminated
-
Children's Healthcare of AtlantaWithdrawn
-
Children's Healthcare of AtlantaCompleted