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Liver Immune Tolerance Marker Utilization Study

NCT02541916 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 69

Last updated 2021-09-30

No results posted yet for this study

Summary

The purpose of this study is to validate and test a tolerance gene expression profile for the identification of operationally tolerant liver transplant recipients, allowing for the successful withdrawal of immunosuppression without rejection in these patients.

Conditions

  • Immunosuppression
  • Immune Tolerance

Interventions

OTHER

Controlled weaning of immunosuppression

At week 0 patients have liver biopsy and liver functional tests (LFTs). Week 1-4 medication reduction to 1.5mg Tacrolimus (Tac) daily or 150mg Cyclosporine A (CsA). At week 4 LFTs. Week 5-8 medication reduction to 1mg Tac / 100mg CsA. Week 8 LFTs. Week 9-12 reduction to 0.5mg Tac/ 50mg CsA. Week 12 LFTs. Week 13-16 reduction to 0mg. Week 16 liver biopsy \& LFTs. Weekly LFTs performed Week 17-20. Monthly LFTs for the next 3 months. LFTs every 3 months for monitoring.

Sponsors & Collaborators

  • University of Toronto

    lead OTHER

Principal Investigators

  • Gary Levy, M.D. · University Health Network, University of Toronto

  • Leslie Lilly, M.D. · University Health Network, Toronto

  • Nazia Selzner, M.D. PhD. · University Health Network, Toronto

  • Meaghan MacArthur, M.Ed · University Health Network, Toronto

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-04-30
Primary Completion
2021-05-31
Completion
2021-05-31

Countries

  • Canada

Study Locations

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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 NCT02541916 on ClinicalTrials.gov