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

• Status: Terminated
• Trial end date: 2007-05-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Baylor College of Medicine
• Collaborator: Roche Pharma AG
• Treatments: Daclizumab; Immunoglobulin G

Criteria

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