CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 100 enrolled
Drug / intervention
Immunosuppression withdrawalbiological
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/NCT02533180
NCT02533180Phase 2Completed
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Evaluation of Donor Specific Immune Senescence and Exhaustion as Biomarkers of Operational Tolerance Following Liver Transplantation in Adults (ITN056ST)

National Institute of Allergy and Infectious Diseases (NIAID)·interventional·Posted Aug 26, 2015·Updated Sep 14, 2023

In Brief

A Phase 2 clinical trial evaluating Immunosuppression withdrawal for Liver Transplant and Liver Transplantation. Completed, enrolled 100 participants across 7 sites.

Detailed Summary

The primary aim of this study is to determine whether a peripheral blood or graft lymphocyte phenotype of immune senescence or exhaustion is different between operationally tolerant and non-tolerant liver allograft recipients.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsLiver Transplant, Liver Transplantation
CountriesUnited States
CollaboratorsImmune Tolerance Network (ITN), PPD Development, LP, Rho Federal Systems Division, Inc.

Timeline

Phase 2CompletedFinished
20162017201820192020202120222023202420252026
First PostedAug 26, 2015
Enrollment StartDec 15, 2015
Primary CompletionFeb 10, 2020
Study CompletionJul 8, 2022
TodayJul 2, 2026
Enrollment to primary: 4.2 yearsPosted 10.8 years ago

Interventions

Immunosuppression withdrawalbiological

Participants will initiate calcineurin inhibitor (CNI) withdrawal after at least 3 weeks of stable liver function, as documented by liver function tests (direct bilirubin, alanine aminotransferase and gamma-glutamyl transferase) separated by at least 1 week in the 3 week period prior to withdrawal. CNI withdrawal will occur in eight 3 week intervals with each subsequent reduction based on liver function tests over the prior 3 week interval. Participants on CNI and prednisone will undergo withdrawal from the two therapies concurrently. If participants are weaned off the CNI successfully, they will initiate non-CNI withdrawal. The non-CNI withdrawal includes two dose reductions of approximately 50% over a 6 week period each, after which the drug will be discontinued.