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Mycophenolate Mofetil Maintenance Therapy for Liver Transplantation

NCT00849238 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2015-10-08

No results posted yet for this study

Summary

The rationale for this study is to determine if Campath-1H can be used in liver transplant recipients to induce a state of immunological unresponsiveness that would not only eliminate the need for calcineurin inhibitors maintenance therapy, but also reduce corticosteroids utilization, decreasing the incidence of acute cellular rejection and perhaps reduce the severity of histologic recurrence of certain autoimmune diseases responsible for causing liver failure. The investigator propose a randomized prospective open label trial in 50 liver transplant recipients who will received a calcineurin inhibitors free immunosuppressive protocol that consist of a single dose of Campath-1H as an induction therapy in association with maintenance mycophenolate mofetil (CellCept®) and low dose steroids. The second group will receive a standard immunosuppressive regimen, which consists of IV steroid induction therapy and maintenance steroids, together with tacrolimus at a full therapeutic dose with no induction antibody therapy.

Conditions

  • Primary Liver Transplant

Interventions

DRUG

mycophenolate mofetil

Sponsors & Collaborators

  • University of Wisconsin, Madison

    lead OTHER

Study Design

Allocation
RANDOMIZED
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
45 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

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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 NCT00849238 on ClinicalTrials.gov