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Study Comparing Simulect Plus Standard Immunosuppression to Standard Immunosuppression Alone for the Prevention of Acute Rejection and Bronchiolitis Obliterans in Lung Transplant

COPD Clinical Trial

Official title:
A Randomized, Double Blind, Placebo Controlled Study Comparing Simulect Plus Standard Immunosuppression to Standard Immunosuppression Alone for the Prevention of Acute Rejection and Bronchiolitis Obliterans Syndrome in Bilateral Lung and Single Lung Transplant Patients

Clinical Trial Summary

The study will evaluate the efficacy and safety of basiliximab Vs placebo as induction therapy combined with standard triple immunosuppression therapy, in the prevention of acute rejection episodes and prevention of Bronchiolitis Obliterans Syndrome.

Clinical Trial Description

The objective of this study is to evaluate the efficacy and safety of basiluximab for the prevention of acute allograft lung rejection when used in addition to Neoral, corticosteroids and azathioprine. Acute rejection episodes will be evaluated during the first 6 months post-transplant. Bronchiolitis obliterans syndrome (BOS) will be evaluated at the end of 1 year after transplant and at additional follow-up visits at 2 and 3 years after transplant. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00188825
Study type Interventional
Source University Health Network, Toronto
Contact
Status Completed
Phase Phase 3
Start date May 2004
Completion date October 2007
View Details
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