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

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Duke University

Status and phase

Completed
Phase 1

Conditions

Organ Transplantation
Immunosuppression
Chronic Hepatitis C

Treatments

Drug: Neoral
Drug: Tacrolimus

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT00286871
6538
6538-04-11R0 (Other Identifier)

Details and patient eligibility

About

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

Full 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.

Sex

All

Ages

18 to 60 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • adult patients who have received liver transplant

Exclusion criteria

  • pregnant women
  • nursing women

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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