NCT00286871

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

Steroid Avoidance in Hep C OLT

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 40 (planned)
• Sponsor: Duke University · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Chronic Hepatitis C
• Organ Transplantation
• Immunosuppression

Interventions

Type	Name	Description
DRUG	Neoral
DRUG	Tacrolimus

Timeline

• Start date: 2006-02-01
• Completion: 2009-02-01
• First posted: 2006-02-06
• Last updated: 2014-09-22

Locations

1 site across 1 country: United States