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NCT00286871 Clinical Trial

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

Chronic Hepatitis C Clinical Trial

Official title:
Steroid Avoidance in Hep C OLT

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00286871
Other study ID # 6538
Secondary ID 6538-04-11R0
Status Completed
Phase Phase 1
First received February 2, 2006
Last updated September 18, 2014
Start date February 2006
Est. completion date February 2009

Study information
Verified date February 2006
Source Duke University
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility
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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Neoral

• Tacrolimus

Locations
Country Name City State
United States Duke University Medical Center Durham North Carolina

Sponsors (2)
Lead Sponsor Collaborator
Duke University Novartis Pharmaceuticals

Country where clinical trial is conducted

United States, 

References & Publications (6)

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

Outcome
Type Measure Description Time frame Safety issue
Primary compare timing & severity of recurrent chronic HCV disease Neoral versus Prograf
Secondary compare the effectiveness of Neoral with Prograf as primary immunotherapy
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