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Use of Daclizumab for the Prevention of Allograft Rejection in Pediatric Heart Transplant Patients

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. Identifier: NCT00284531
Recruitment Status : Terminated (Slow enrollment)
First Posted : February 1, 2006
Last Update Posted : October 16, 2015
Roche Pharma AG
Information provided by:
Baylor College of Medicine

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.

Condition or disease Intervention/treatment Phase
Cardiac Transplantation Drug: Daclizumab Phase 1 Phase 2

Detailed Description:

Initial studies in renal and recent studies in adult cardiac transplant patients have shown Zenapax(R) to be both efficacious and safe when used in several different dosing schedules. Little data is available regarding pharmacokinetics, safety and appropriate dosing in pediatric heart transplant patients. Yet this ever-increasing group of patients presents a significant challenge for the prevention of primary rejection and the appropriate maintenance of immunosuppression. Induction of long term allograft acceptance through peripheral tolerance has been shown in animal models to be more easily induced in young animals. Once established however, allograft rejection and immunologic responses in the young are quite vigorous. This dichotomy makes young allograft recipients a particularly attractive population for the study of immune modulators targeted at preventing proliferative expansion of alloreactive T cell clones. This is precisely the mode of action of anti-IL2R monoclonal reagents such as Zenapax(R).

Although some pharmacokinetic data have been generated in adult heart transplant patients on multidrug immunosuppressive regimens including both Zenapax(R) and mycophenolate mofetil (MMF), detailed pharmacokinetic data on this combination in multidrug immunosuppressive regimens is not available for pediatric heart transplant subjects.


  • Determination of pharmacokinetics of Zenapax(R) in pediatric patients receiving a uniform multidrug immunosuppressive regimen for primary induction.
  • Determine whether there are any unusual drug interactions peculiar to the pediatric population that would require dosing modification.

Secondary objectives:

  • Investigate long term effects of Zenapax(R) containing induction regimen on pediatric patients.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Use of Zenapax (Daclizumab) for the Prevention of Primary Acute Cardiac Rejection in Children and Adolescents. Ind Number: 10100
Study Start Date : October 2003
Actual Primary Completion Date : May 2007
Actual Study Completion Date : May 2007

Resource links provided by the National Library of Medicine

Drug Information available for: Daclizumab

Primary Outcome Measures :
  1. Drug levels at scheduled time points
  2. Receptor saturation at scheduled time points
  3. Number of rejection episodes in 1 year

Secondary Outcome Measures :
  1. Changes in T cell subsets over observation period
  2. Numbers of bacterial and opportunistic infections
  3. Evidence for autoimmune disease over observation period

Information from the National Library of Medicine

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Ages Eligible for Study:   1 Month to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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

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 identifier (NCT number): NCT00284531

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United States, Texas
Baylor College of Medicine
Houston, Texas, United States, 77030
Sponsors and Collaborators
Baylor College of Medicine
Roche Pharma AG
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Principal Investigator: Howard M Rosenblatt, MD Baylor College of Medicine
Layout table for additonal information Identifier: NCT00284531    
Other Study ID Numbers: ZEN122
H-18397 ( Other Identifier: Baylor College of Medicine )
First Posted: February 1, 2006    Key Record Dates
Last Update Posted: October 16, 2015
Last Verified: October 2015
Keywords provided by Baylor College of Medicine:
cardiac transplantation
allograft rejection
Additional relevant MeSH terms:
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Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs