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 The purpose of this study is to determine whether immunosuppressive drugs can be safely withdrawn over a minimum of 9 months from children who received liver transplants at least 4 years ago.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 range4 Years – 18 Years

SexALL

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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

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Proportion of Participants Successfully Withdrawn From Immunosuppression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