Ignite Creation Date:
2024-05-05 @ 4:50 PM
Last Modification Date:
2024-10-26 @ 9:24 AM
Study NCT ID:
NCT00320606
Status:
COMPLETED
Last Update Posted:
2018-09-20
First Post:
2006-04-28
Brief Title:
Withdrawal of Immunosuppression in Pediatric Liver Transplant Recipients
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
Immunosuppression Withdrawal for Pediatric Living-donor Liver Transplant Recipients ITN029ST
Status:
COMPLETED
Status Verified Date:
2018-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
WISP-R
Brief Summary:
Antirejection medicines also known as immunosuppressive drugs are prescribed to organ transplant recipients to prevent their bodies from rejecting the new organ Long-term use of these drugs places transplant recipients at higher risk of serious infections and certain types of cancer The purpose of this study is to determine whether immunosuppressive drugs can be safely withdrawn over a minimum of 9 months from children who received liver transplants at least 4 years ago
Detailed Description:
In order to prevent the rejection of transplanted organs transplant recipients are prescribed a strict lifelong regimen of immunosuppressive drugs While these drugs help prevent the body from rejecting the transplant they carry numerous complications including increased risk of serious infections and certain types of cancer However there is mounting evidence that a significant percentage of liver transplant recipients can maintain a healthy functioning transplant without ongoing immunosuppression This study will determine whether gradual withdrawal and eventual discontinuation of all immunosuppressive medication can be safely accomplished in children who received a liver transplant from a parent Twenty eligible participants who were under 18 years old at the time of transplant whose donor was a parent and who received the transplant at least four years ago will be enrolled in the study
Liver recipients will have an initial screening assessment consisting of a medical history liver biopsy and urine and blood collection Eligible recipients will be placed on a modified medication schedule to gradually decrease their immunosuppression medication slowly over a 9- to 12-month period during which time they will be closely monitored by study staff Immunosuppressive drugs will not be provided by this study For a minimum of 3 and up to a maximum of 7 years monthly telephone consultations and quarterly study visits will occur Visits will include physical exams and blood collection to monitor the childrens health during the withdrawal phase The exact schedule of immunosuppressant withdrawal will be determined by study physicians based on participants health and immune function test results Donor and nondonor parents will be asked to each provide one blood sample during the initial study visits for immunologic and genetic testing
IMPORTANT NOTICE The National Institute of Allergy and Infectious Diseases and the Immune Tolerance Network do not recommend the discontinuation of immunosuppressive therapy for recipients of cell organ or tissue transplants outside of physician-directed controlled clinical studies Discontinuation of prescribed immunosuppressive therapy can result in serious health consequences and should only be performed in certain rare circumstances upon the recommendation and with the guidance of your health care provider
Liver recipients will have an initial screening assessment consisting of a medical history liver biopsy and urine and blood collection Eligible recipients will be placed on a modified medication schedule to gradually decrease their immunosuppression medication slowly over a 9- to 12-month period during which time they will be closely monitored by study staff Immunosuppressive drugs will not be provided by this study For a minimum of 3 and up to a maximum of 7 years monthly telephone consultations and quarterly study visits will occur Visits will include physical exams and blood collection to monitor the childrens health during the withdrawal phase The exact schedule of immunosuppressant withdrawal will be determined by study physicians based on participants health and immune function test results Donor and nondonor parents will be asked to each provide one blood sample during the initial study visits for immunologic and genetic testing
IMPORTANT NOTICE The National Institute of Allergy and Infectious Diseases and the Immune Tolerance Network do not recommend the discontinuation of immunosuppressive therapy for recipients of cell organ or tissue transplants outside of physician-directed controlled clinical studies Discontinuation of prescribed immunosuppressive therapy can result in serious health consequences and should only be performed in certain rare circumstances upon the recommendation and with the guidance of your health care provider
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None