NCT00284531

Brief Summary

This protocol is designed to obtain information on the drug levels, metabolism, and safety of daclizumab (Zenapax(R)) in children and adolescents undergoing cardiac transplantation. In addition to the drug safety and metabolism information, the number and severity of rejection episodes in patients undergoing cardiac transplantation using the standard immunosuppressive drugs plus daclizumab will be compared with patients who have previously undergone cardiac transplantation at the Baylor College of Medicine and received the same standard immunosuppressive drugs without daclizumab.

Trial Health

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Trial Health Score

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

Enrollment
1

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Oct 2003

Typical duration for phase_1

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2003

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

January 31, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 1, 2006

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2007

Completed
Last Updated

October 16, 2015

Status Verified

October 1, 2015

Enrollment Period

3.6 years

First QC Date

January 31, 2006

Last Update Submit

October 14, 2015

Conditions

Cardiac Transplantation

Keywords

cardiac transplantationallograft rejectionanti-CD25

Outcome Measures

Primary Outcomes (3)

  • Drug levels at scheduled time points

  • Receptor saturation at scheduled time points

  • Number of rejection episodes in 1 year

Secondary Outcomes (3)

  • Changes in T cell subsets over observation period

  • Numbers of bacterial and opportunistic infections

  • Evidence for autoimmune disease over observation period

Interventions

DaclizumabDRUG

Eligibility Criteria

Age1 Month - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Patients must be undergoing their first cardiac allograft transplant.
  • Male or female must be less than or equal to 18 years of age.
  • Women of childbearing potential must have a negative serum pregnancy test within 48 hours prior to transplantation. The sensitivity must be equal to at least 50 mIU/ml. (Urine test is allowed in addition to serum test in patients where serum results are delayed.)
  • Women of childbearing potential must use two reliable forms of contraception simultaneously.
  • Effective contraception must be used before beginning study drug therapy, and for 4 months following discontinuation of study drug therapy.
  • Patients and/or their guardians must be willing and be capable of understanding the purpose and risks of the study and must sign a statement of informed consent.

You may not qualify if:

  • Patients with a history of hypersensitivity reactions to any of the constituents of the Zenapax(R) preparation or having had hypersensitivity reactions to human or murine immune globulin preparations in the past.
  • Women lactating, pregnant or of childbearing potential not using, or who are unwilling to use two reliable forms of contraception simultaneously during the study
  • History of a psychological illness or condition which would interfere with the patient's ability to understand the requirements of the study
  • White blood count \< 2500/mm\^3, platelets \< 50,000 /mm\^3 or hemoglobin \< 6 g/dL.
  • HIV-1 infection or the presence of positive hepatitis B surface antigen (HBsAg) or chronic hepatitis C.
  • Active peptic ulcer disease
  • Severe diarrhea or other gastrointestinal disorders which might interfere with the ability to absorb oral medication
  • Malignancies within the past 5 years, excluding skin carcinomas (basal or squamous cell) that have been adequately treated
  • Patients who have received within the past 30 days or require concomitant treatment with other investigational drugs or immunosuppressive medications that are prohibited for this study
  • Inability to start microemulsion form of cyclosporine within 72 hours

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Baylor College of Medicine

Houston, Texas, 77030, United States

Location

MeSH Terms

Interventions

Daclizumab

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Study Officials

  • Howard M Rosenblatt, MD

    Baylor College of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 31, 2006

First Posted

February 1, 2006

Study Start

October 1, 2003

Primary Completion

May 1, 2007

Study Completion

May 1, 2007

Last Updated

October 16, 2015

Record last verified: 2015-10

Locations

US(1)