A 24-month, multi-center, single arm, prospective study to evaluate renal function, efficacy, safety and tolerablility of everolimus in combination with reduced exposure cyclosporine or tacrolimus in pediatric liver transplant recipients
A study of liver transplant recipients to evaluate renal function, effectiveness and safety of a study drug, everolimus
Sponsor: Novartis
Enrolling: Male and Female Patients
Study Length: 24 Months
Clinic Visits: 10
IRB Number: AAAL7808
Contact: Theresa Lukose: 212 305 3839 / tt2103@columbia.edu
Additional Study Information: The purpose of this study is to investigate a new therapeutic regimen with or without steroids in the pediatric population. The aim is to find out whether everolimus is safe and has beneficial effects in children who receive a liver transplant. All children will receive a study drug called everolimus twice a day plus a reduced dose of cyclosporine or tacrolimus, with the earliest dose at 1 month and the latest 6 months after liver transplantation in combination with low dose of corticosteroids. Your child will be treated in the study for 24 months, and they will be required to attend the clinic for 10 study evaluation visits. The Screening visit should occur within 7 days before the baseline visit. The baseline visit should occur within 24 hours of taking the first dose of everolimus. Thereafter, they will come for 8 additional study evaluation visits.
This study is closed
Investigator
Tomoaki Kato, MD
Do You Qualify?
Has your child received a liver transplant in the last 6 months? Yes No
Is your child on an immunosuppresive regimen? Yes No
Did your child have acute liver failure? Yes No
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For more information, please contact:
Theresa Lukose
tt2103@columbia.edu
212 305 3839