CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 20 enrolled
Drug / intervention
Immunosuppression Withdrawaldrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00320606
NCT00320606Phase 1Completed
CompareCT.gov

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

National Institute of Allergy and Infectious Diseases (NIAID)·interventional·Posted May 3, 2006·Updated Sep 20, 2018

In Brief

A Phase 1 clinical trial evaluating Immunosuppression Withdrawal for Liver Transplant and Liver Transplantation. Completed, enrolled 20 participants across 3 sites.

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 The purpose of this study is to determine whether immunosuppressive drugs can be safely withdrawn over a minimum of 9 months from children who received liver transplants at least 4 years ago.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsLiver Transplant, Liver Transplantation
CountriesUnited States
CollaboratorsImmune Tolerance Network (ITN)

Timeline

Phase 1CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMay 3, 2006
Enrollment StartJun 5, 2006
Primary CompletionNov 30, 2009
Study CompletionMar 13, 2017
TodayJul 2, 2026
Enrollment to primary: 3.5 yearsPosted 20.2 years ago

Interventions

Immunosuppression Withdrawaldrug

Gradual withdrawal of immunosuppressive medication. With high dose, daily dose reduction by 25% for 8 weeks. With low dose, daily dose reduction by 25% for 4 weeks.