CompletedPhase 1

Withdrawal of Immunosuppression in Pediatric Liver Transplant Recipients

United States20 participantsStarted 2006-06-05

Plain-language 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 The purpose of this study is to determine whether immunosuppressive drugs can be safely withdrawn over a minimum of 9 months from children who received liver transplants at least 4 years ago.

Who can participate

Age range

4 Years – 18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Proportion of Participants Successfully Withdrawn From Immunosuppression

Timeframe: 1 year after completion of immunosuppression withdrawal

Trial details

NCT IDNCT00320606

SponsorNational Institute of Allergy and Infectious Diseases (NIAID)

Sponsor typeNIH

Study typeINTERVENTIONAL

Primary completion2009-11-30

Results submitted2011-06-08

View on ClinicalTrials.gov More Liver Transplant trials