ClinicalTrials.gov
ClinicalTrials.gov Menu

Daclizumab Experience in Pediatric Heart Transplant

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00486057
Recruitment Status : Terminated (sufficient data collected for conclusion of retrospective study)
First Posted : June 13, 2007
Last Update Posted : November 21, 2011
Sponsor:
Information provided by:
Children's Healthcare of Atlanta

Brief Summary:
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.

Condition or disease
Congenital Disorders

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 : Observational
Actual Enrollment : 30 participants
Time Perspective: Retrospective
Official Title: A Retrospective Review of Daclizumab Experience in Pediatric Heart Transplant
Study Start Date : August 2004
Actual Study Completion Date : November 2007

Resource links provided by the National Library of Medicine

Drug Information available for: Daclizumab
U.S. FDA Resources





Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   up to 21 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Status post heart transplant Age 0-21 years Received Daclizumab as induction therapy
Criteria

Inclusion Criteria:

  • Status post heart transplant
  • Age 0-21 years
  • Received Daclizumab as induction therapy

Exclusion Criteria:

  • Those who do not meet inclusion criteria

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00486057


Locations
United States, Georgia
Children's Healthcare of Atlanta
Atlanta, Georgia, United States, 30322
Sponsors and Collaborators
Children's Healthcare of Atlanta
Investigators
Principal Investigator: Kirk R Kanter, MD Children's Healthcare of Atlanta, Pediatric Surgery

Responsible Party: Director Research, Children's Healthcare of Atlanta Institutional Review Board
ClinicalTrials.gov Identifier: NCT00486057     History of Changes
Other Study ID Numbers: 06-199
First Posted: June 13, 2007    Key Record Dates
Last Update Posted: November 21, 2011
Last Verified: November 2007

Keywords provided by Children's Healthcare of Atlanta:
Daclizumab
Immuno-suppression protocol
Heart Transplant
Rejection

Additional relevant MeSH terms:
Daclizumab
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs