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

Phase 1
4 Years
18 Years
Open (Enrolling)
Liver Transplantation, Immunosuppression

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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

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.

Inclusion Criteria

Inclusion Criteria for Liver Recipients:

- Received liver from living parent donor

- Received transplant at least 4 years prior to study entry

- Less than 18 years of age at time of transplant

- Parent or guardian willing to provide informed consent

Inclusion Criteria for Liver Donors:

- Willing to participate in this study

Exclusion Criteria for Liver Recipients:

- Underwent transplant because of liver failure related to autoimmune disease

- Underwent transplant of a second organ simultaneously with or after liver transplant
OR liver retransplantation

- Receiving immunosuppression with more than one drug

- 50% increase in dose of current immunosuppressive drug

- HIV infection

- Hepatitis B or C virus infection

- Pregnancy or breastfeeding

Type of Study:


Study Design:

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Proportion of Subjects Successfully Withdrawn From Immunosuppression

Outcome Description:

Subjects were considered successfully withdrawn from immunosuppression if they remained off immunosuppression for at least one year with normal allograft function

Outcome Time Frame:

1 year after completion of immunosuppression withdrawal

Safety Issue:


Principal Investigator

Sandy Feng, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of California, San Francisco


United States: Federal Government

Study ID:




Start Date:

May 2006

Completion Date:

July 2014

Related Keywords:

  • Liver Transplantation
  • Immunosuppression
  • anti-rejection
  • living donor transplant



University of California, San Francisco San Francisco, California  94143
Children's Memorial Hospital Chicago, Illinois  60614
Columbia University Medical Center New York, New York  10032