NCT00048165

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

A Double-Blind, Placebo -Controlled, Randomized Study to Assess the Efficacy and Safety of Zenapax in Combination With CellCept, Cyclosporine, and Corticosteroids in Patients Undergoing Cardiac Transplantation.

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 434 (actual)
• Sponsor: Hoffmann-La Roche · Industry
• Sex: All
• Age: 13 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Heart Transplantation

Interventions

Type	Name	Description
DRUG	Daclizumab	Daclizumab will be administered as 1 mg/kg IV within 12 hours post-op (Day 1), and Days 8, 22, 36 and 50.
DRUG	Methylprednisolone	Methylprednisolone will be administered as 500-1000 mg IV and peri-operative switch to oral at 0.5-1 mg/kg/day followed by tapering till 0.0-0.15 mg/kg/day (up to 365 days).
DRUG	Mycophenolate mofetil	Mycophenolate mofetil will be administered as 1.5 grams bid begun post-op, either IV or orally as required up to 365 days.
DRUG	Placebo	Matching placebo will be administered on Days 1, 8, 22, 36, and 50.
DRUG	cyclosporine	Cyclosporine will be administered as 1-4 mg/kg IV or 2-6 mg/kg orally up to 365 days.

Timeline

• Start date: 1999-08-01
• Primary completion: 2002-08-01
• Completion: 2002-08-01
• First posted: 2002-10-25
• Last updated: 2016-06-13
• Results posted: 2016-06-13

Locations

30 sites across 4 countries: United States, Canada, Germany, Sweden