Chronic Hepatitis C, Organ Transplantation, Immunosuppression
Conditions
Brief summary
Liver transplant subjects will be given Mycophenolate (MMF) and Tacrolimus in order to help prevent post-transplant rejection.
Detailed description
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.
Interventions
DRUGNeoral
DRUGTacrolimus
Sponsors
Novartis Pharmaceuticals
Duke University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* adult patients who have received liver transplant
Exclusion criteria
* pregnant women * nursing women
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| compare timing & severity of recurrent chronic HCV disease Neoral versus Prograf | — |
Secondary
| Measure | Time frame |
|---|---|
| compare the effectiveness of Neoral with Prograf as primary immunotherapy | — |
Countries
United States
Outcome results
None listed