drugset
drugset / Trial / NCT00048165

A Study to Evaluate the Efficacy and Safety of Zenapax in Combination With CellCept, Cyclosporine, and Corticosteroids in Patients Undergoing Cardiac Transplantation

NCT00048165 ↗

Phase 4 Completed 434 enrolled Hoffmann-La Roche
RandomizedParallel-groupDouble-blindTreatment

Summary

The purpose of the study is to compare the number of randomized participants in each treatment group who experience an acute rejection episode in the first 6 months after undergoing cardiac transplantation.

Timeline

Start
1999-08
Primary completion
2002-08
Completion
2002-08

Outcome

Met primary endpoint

registry analysis (superiority or other test); Daclizumab vs Placebo; p = 0.007; percent mean difference -12.0 (95% CI -20.9 to -3.3); Cochran-Mantel-Haenszel NCT00048165 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Daclizumab Monoclonal antibody 1 mg/kg Intravenous
Background Cyclosporine Peptide 1 mg/kg Intravenous
Background Cyclosporine Peptide 2 mg/kg Intravenous
Background Cyclosporine Peptide 4 mg/kg Intravenous
Background Cyclosporine Peptide 6 mg/kg Intravenous
Background Methylprednisolone Other / unclassified 0.5 mg/kg Intravenous
Background Methylprednisolone Other / unclassified 1 mg/kg Intravenous
Background Mycophenolate Mofetil Small molecule 1.5 g Intravenous

Indications

No indication recorded.