CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 161 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/NCT01638559
NCT01638559Phase 2Completed
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Immunosuppression Withdrawal for Stable Pediatric Liver Transplant Recipients

National Institute of Allergy and Infectious Diseases (NIAID)·interventional·Posted Jul 11, 2012·Updated Oct 7, 2019

In Brief

A Phase 2 clinical trial evaluating Immunosuppression withdrawal for Liver Transplant Recipients and 2 related conditions. Completed, enrolled 161 participants across 12 sites in 2 countries.

Detailed Summary

The primary objective of this study is to assess the efficacy of immunosuppression withdrawal (ISW) in pediatric liver transplant (tx) recipients.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsLiver Transplant Recipients, Liver Transplantation, Immunosuppression
CountriesCanada, United States
CollaboratorsNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Immune Tolerance Network (ITN)

Timeline

Phase 2CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedJul 11, 2012
Enrollment StartAug 14, 2012
Primary CompletionMar 31, 2016
Study CompletionJun 11, 2018
TodayJul 2, 2026
Enrollment to primary: 3.6 yearsPosted 14.0 years ago

Interventions

Immunosuppression withdrawaldrug

Participants will undergo gradual ISW in no less than 36 weeks and no more than 52 weeks with frequent monitoring of liver tests. All participants will be followed for 48 months ensuring a minimum of 36 months of follow-up after successful ISW.