drugset / Trial / NCT02554955

A Study of Daclizumab (Zenapax) in Combination With Mycophenolate Mofetil (CellCept) and Sirolimus in Prevention of Acute Rejection in Heart Transplant Participants

NCT02554955

Phase 4 Completed 36 enrolled Hoffmann-La Roche
Non-randomizedSingle-groupOpen-labelTreatment

Summary

This study will evaluate the efficacy and safety of intravenous daclizumab in combination with oral mycophenolate mofetil and oral sirolimus in participants receiving a heart transplant, and at risk of impaired kidney function. The anticipated time on study treatment is 6 months, and the target sample size is 44 individuals.

Timeline

Start
2004-02
Primary completion
2007-12
Completion
2007-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Daclizumab Monoclonal antibody 1 mg/kg Intravenous
Background Mycophenolate Mofetil Small molecule 1 g Oral
Background Sirolimus Small molecule 3 mg Oral

Indications

No indication recorded.