Randomized Controlled Trial in Liver Transplant Recipients Treated in Steroid Sparing Regimen

Duke University40 enrolled

Overview

Liver transplant subjects will be given Mycophenolate (MMF) and Tacrolimus in order to help prevent post-transplant rejection.

Recurrent HCV in the liver allograft is becoming the leading indicator for retransplantation. Studies suggest that glucocorticord-based immunosuppression regimens hasten the onset and progression of recurrent chronic HCV liver disease. Treatment of acute allograft rejection with steroid boluses is also associated with rapid HCV recurrence. The relative contribution of various calcineurin inhibitors to recurrent HCV liver disease has not been established. Previous retrospective studies, as well as prospective studies have not demonstrated a difference in recurrent HCV liver disease rates between patients receiving CsA or tacrolimus immunosuppression regimens respectively.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Chronic Hepatitis C Organ Transplantation Immunosuppression

Interventions

NeoralDRUG

TacrolimusDRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 60 Years

Medical Language ↔ Plain English

Inclusion Criteria: * adult patients who have received liver transplant Exclusion Criteria: * pregnant women * nursing women

Locations (1)

Duke University Medical Center

Durham, North Carolina, United States

Outcomes

Primary Outcomes

compare timing & severity of recurrent chronic HCV disease Neoral versus Prograf

Secondary Outcomes

compare the effectiveness of Neoral with Prograf as primary immunotherapy

Data from ClinicalTrials.gov

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