Randomized Controlled Trial in Liver Transplant Recipients Treated in Steroid Sparing Regimen - Full Text View

Sponsors and Collaborators:	Duke University Novartis
Information provided by:	Duke University
ClinicalTrials.gov Identifier:	NCT00286871

Purpose

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

Condition	Intervention	Phase
Chronic Hepatitis C Organ Transplantation Immunosuppression	Drug: Neoral Drug: Tacrolimus	Phase I

MedlinePlus related topics: Hepatitis Hepatitis C Liver Transplantation

Drug Information available for: Tacrolimus anhydrous Tacrolimus

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Steroid Avoidance in Hep C OLT

Further study details as provided by Duke University:

Primary Outcome Measures:

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

Secondary Outcome Measures:

compare the effectiveness of Neoral with Prograf as primary immunotherapy

Estimated Enrollment:	40
Study Start Date:	February 2006
Estimated Study Completion Date:	February 2009

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.

Eligibility

Ages Eligible for Study:	18 Years to 60 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

adult patients who have received liver transplant

Exclusion Criteria:

pregnant women
nursing women

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00286871

Locations

United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27710

Sponsors and Collaborators

Duke University

Novartis

Investigators

Principal Investigator:

Devai Desai, MD, PhD

Duke University

More Information

Publications:

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.

Berenguer M, Prieto M, Palau A, Rayon JM, Carrasco D, Juan FS, Lopez-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.

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.

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. No abstract available.

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.

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.

Study ID Numbers:	6538-04-11R0
Study First Received:	February 2, 2006
Last Updated:	February 2, 2006
ClinicalTrials.gov Identifier:	NCT00286871 History of Changes
Health Authority:	United States: Institutional Review Board

Study placed in the following topic categories:

Liver Diseases
Cyclosporine
Hepatitis, Chronic
Immunologic Factors
Hepatitis, Viral, Human
Tacrolimus
Cyclosporins

Immunosuppressive Agents
Hepatitis
Virus Diseases
Digestive System Diseases
Hepatitis C
Hepatitis C, Chronic

Additional relevant MeSH terms:

Liver Diseases
RNA Virus Infections
Hepatitis, Chronic
Flaviviridae Infections
Immunologic Factors
Physiological Effects of Drugs
Hepatitis, Viral, Human
Tacrolimus

Immunosuppressive Agents
Pharmacologic Actions
Hepatitis
Virus Diseases
Digestive System Diseases
Hepatitis C
Hepatitis C, Chronic

ClinicalTrials.gov processed this record on May 07, 2009