NCT00486057

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Aug 2004

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2004

Completed
2.9 years until next milestone

First Submitted

Initial submission to the registry

June 12, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 13, 2007

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2007

Completed
Last Updated

November 21, 2011

Status Verified

November 1, 2007

First QC Date

June 12, 2007

Last Update Submit

November 18, 2011

Conditions

Congenital Disorders

Keywords

DaclizumabImmuno-suppression protocolHeart TransplantRejection

Eligibility Criteria

AgeUp to 21 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Children's Healthcare of Atlanta

Atlanta, Georgia, 30322, United States

Location

MeSH Terms

Conditions

Congenital, Hereditary, and Neonatal Diseases and AbnormalitiesRejection, Psychology

Condition Hierarchy (Ancestors)

Social BehaviorBehavior

Study Officials

  • Kirk R Kanter, MD

    Children's Healthcare of Atlanta, Pediatric Surgery

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 12, 2007

First Posted

June 13, 2007

Study Start

August 1, 2004

Study Completion

November 1, 2007

Last Updated

November 21, 2011

Record last verified: 2007-11

Locations

US(1)