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

Phase 1

Completed

• Conditions: Chronic Hepatitis C; Organ Transplantation; Immunosuppression

• Registration Number: NCT00286871
• Lead Sponsor: Duke University

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.

Study Timeline

• Status Verified: 2006-02
• Study Start: 2006-02
• Study First Submitted: 2006-02-02
• Study First Submitted QC: 2006-02-02
• Study First Posted: 2006-02-06
• Study Completion: 2009-02
• Last Update Submitted: 2014-09-18
• Last Update Posted: 2014-09-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• adult patients who have received liver transplant

Exclusion Criteria

• pregnant women
• nursing women

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
compare the effectiveness of Neoral with Prograf as primary immunotherapy

Trial Locations

Locations (1)

Duke University Medical Center; 🇺🇸 Durham, North Carolina, United States