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
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 |
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
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 |