drugset / Trial / NCT00284531

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

NCT00284531

Phase 1/2 Terminated 1 enrolled Baylor College of Medicine Roche Pharma AG · collab
Non-randomizedSingle-groupOpen-labelTreatment

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.

Timeline

Start
2003-10
Primary completion
2007-05
Completion
2007-05

Drugs

EvaluationDrugModalityDoseRoute
Subject Daclizumab Monoclonal antibody

Indications

No indication recorded.