MedTrace Logo

Liver Immunosuppression Free Trial

NCT02498977 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 116

Last updated 2024-03-07

No results posted yet for this study

Summary

LIFT is prospective randomised marker-based trial to assess the clinical utility and safety of biomarker-guided immunosuppression withdrawal in liver transplantation. 'LIFT' aims to validate a biomarker test of operational tolerance to stratify liver transplant recipients before withdrawing immunosuppressive medication. Primary objective is clinical utility and risk/benefit ratio of employing a transcriptional test of tolerance to stratify liver recipients prior to immunosuppression withdrawal. Secondary objectives are: safety of biomarker-guided immunosuppression withdrawal; health-economic and quality of life impact of biomarker-guided immunosuppression withdrawal; improvement in drug-related co-morbidities; prevalence of tolerance over time; role of donor-specific anti-human leukocyte antigen (HLA) antibodies; identify mechanisms of liver allograft tolerance. It is a prospective, multi-centre, phase IV, biomarker-strategy design trial with a randomized control group in which adult liver transplant recipients will undergo immunosuppression withdrawal. The sample size is 148 patients.

Conditions

  • Transplantation, Liver

Interventions

GENETIC

Biomarker

Real time polymerase chain reaction (PCR) gene expression measurement

DRUG

Tacrolimus, cyclosporine and/or mycophenolic acid, mycophenolate mofetil or azathioprine

Immunosuppression drugs as per protocol

Sponsors & Collaborators

  • King's College Hospital NHS Trust

    collaborator OTHER

  • National Institute for Health Research, United Kingdom

    collaborator OTHER_GOV

  • King's College London

    lead OTHER

Principal Investigators

  • Alberto Sanchez-Fueyo · King's College London

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-10-31
Primary Completion
2021-12-31
Completion
2021-12-31

Countries

  • United Kingdom

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02498977 on ClinicalTrials.gov