Trial Information

Immunosuppression Withdrawal for Pediatric Living-donor Liver Transplant Recipients (ITN029ST)

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 patients 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 children's
health during the withdrawal phase. The exact schedule of immunosuppressant withdrawal will
be determined by study physicians based on participant's 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.