Related Information
- Trial Status:
Closed to Enrollment - Phase: IV
- Patients will participate in the study for 12 months after transplantation. Patients who have maintained the study assigned regimen for 24 months post-transplantation will be evaluated at that time to determine the long term safety and efficacy of the regimen.
Current Clinical Trials:
Liver:
- Safety Study of rhMBL in Liver Transplant Recipients
- Randomized Study of Everolimus in Liver Transplant Recipients
- Safety and Anti-Tumor Effects of NV1020 in Metastatic Colon Cancer
- Safety and Efficacy of Long-Term Calcineurin Inhibitor-free Immunosuppression in Liver Transplant Patients
- Randomized Study of Recurrent Hepatitis C after Liver Transplantation
- Hepatocellular Research Registry
Safety and Efficacy of Long-Term Calcineurin Inhibitor-free Immunosuppression in Liver Transplant Pa
Title: A Prospective, Open-Label, Multi-Center, Randomized Trial of the Efficacy and Safety of a Long-Term Calcineurin Inhibitor Free Maintenance Regimen with Mycophenolate Mofetil and Sirolimus in Recipients of an Orthotopic Liver Transplant
Why is this study being done?
This study will assess the efficacy and safety of a long-term calcineurin inhibitor (CNI)-free maintenance regimen with CellCept and sirolimus in recipients of an orthotropic liver transplant.
Who is Eligible to Participate in the Study?
• Primary deceased donor liver transplant
• CellCept plus tacrolimus or cyclosporine from time of transplantation (within 72 hours)
• Patients with hepatitis C-positive status may be entered if they have had an intraoperative (backtable) biopsy of the transplanted liver or will have a biopsy at the time of randomization. This is not required for patients negative for hepatitis C.
Minimum Age:
18
Maximum Age:
74
What is Involved With this Study?
Patients will be randomized to one of two regimens, one with a CNI and one without, each in combination with CellCept. Group A will receive combination therapy with CellCept and tacrolimus. Patients in Group B will be withdrawn from tacrolimus and maintained on combination therapy with CellCept + Sirolimus.
Contact Information
For more information on this trial, or to participate, please contact Stephanie Logan at (615) 936-8421.