Chronic Hepatitis C Clinical Trial
Official title:
Steroid Avoidance in Hep C OLT
Verified date | February 2006 |
Source | Duke University |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Interventional |
Liver transplant subjects will be given Mycophenolate (MMF) and Tacrolimus in order to help prevent post-transplant rejection.
Status | Completed |
Enrollment | 40 |
Est. completion date | February 2009 |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 60 Years |
Eligibility |
Inclusion Criteria: - adult patients who have received liver transplant Exclusion Criteria: - pregnant women - nursing women |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Duke University Medical Center | Durham | North Carolina |
Lead Sponsor | Collaborator |
---|---|
Duke University | Novartis Pharmaceuticals |
United States,
Berenguer M, Prieto M, Palau A, Rayón JM, Carrasco D, Juan FS, López-Labrador FX, Moreno R, Mir J, Berenguer J. Severe recurrent hepatitis C after liver retransplantation for hepatitis C virus-related graft cirrhosis. Liver Transpl. 2003 Mar;9(3):228-35. — View Citation
Eason JD, Loss GE, Blazek J, Nair S, Mason AL. Steroid-free liver transplantation using rabbit antithymocyte globulin induction: results of a prospective randomized trial. Liver Transpl. 2001 Aug;7(8):693-7. — View Citation
Gane EJ, Portmann BC, Naoumov NV, Smith HM, Underhill JA, Donaldson PT, Maertens G, Williams R. Long-term outcome of hepatitis C infection after liver transplantation. N Engl J Med. 1996 Mar 28;334(13):815-20. — View Citation
Knodell RG, Ishak KG, Black WC, Chen TS, Craig R, Kaplowitz N, Kiernan TW, Wollman J. Formulation and application of a numerical scoring system for assessing histological activity in asymptomatic chronic active hepatitis. Hepatology. 1981 Sep-Oct;1(5):431-5. — View Citation
McCaughan GW, Zekry A. Pathogenesis of hepatitis C virus recurrence in the liver allograft. Liver Transpl. 2002 Oct;8(10 Suppl 1):S7-S13. Review. — View Citation
Zervos XA, Weppler D, Fragulidis GP, Torres MB, Nery JR, Khan MF, Pinna AD, Kato T, Miller J, Reddy KR, Tzakis AG. Comparison of tacrolimus with neoral as primary immunosuppression in hepatitis C patients after liver transplantation. Transplant Proc. 1998 Jun;30(4):1405-6. — View Citation
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Secondary | compare the effectiveness of Neoral with Prograf as primary immunotherapy |
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