Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsors and Collaborators: |
University Health Network, Toronto Novartis |
---|---|
Information provided by: | University Health Network, Toronto |
ClinicalTrials.gov Identifier: | NCT00188825 |
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.
Condition | Intervention | Phase |
---|---|---|
Lung Transplant |
Drug: Simulect (Basiliximab) |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Single Group Assignment, Efficacy Study |
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 |
Estimated Enrollment: | 30 |
Study Start Date: | May 2004 |
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.
Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion criteria
Exclusion Criteria:
Canada, Ontario | |
Toronto General Hospital | |
Toronto, Ontario, Canada, M5G 2C4 |
Principal Investigator: | Thomas K Waddell, MD FRCSC | University Health Network, Toronto |
Principal Investigator: | Cecilia Chaparro, MD | University Health Network, Toronto |
Study ID Numbers: | CCHI621AES05 |
Study First Received: | September 12, 2005 |
Last Updated: | September 7, 2006 |
ClinicalTrials.gov Identifier: | NCT00188825 |
Health Authority: | United States: Food and Drug Administration; Canada: Health Canada |
Lung Transplant Rejection BOS |
Basiliximab Lung Diseases, Interstitial Lung Diseases, Obstructive Respiratory Tract Infections Respiratory Tract Diseases |
Lung Diseases Bronchiolitis Bronchitis Bronchiolitis Obliterans |
Immunologic Factors Bronchial Diseases Physiological Effects of Drugs Immunosuppressive Agents Pharmacologic Actions |