Status:
TERMINATED
Use of Daclizumab for the Prevention of Allograft Rejection in Pediatric Heart Transplant Patients
Lead Sponsor:
Baylor College of Medicine
Collaborating Sponsors:
Roche Pharma AG
Conditions:
Cardiac Transplantation
Eligibility:
All Genders
1-18 years
Phase:
PHASE1
PHASE2
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...
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 a...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2007
Estimated Enrollment :
1 Patients enrolled
Trial Details
Trial ID
NCT00284531
Start Date
October 1 2003
End Date
May 1 2007
Last Update
October 16 2015
Active Locations (1)
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1
Baylor College of Medicine
Houston, Texas, United States, 77030