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

Primary Purpose

Chronic Hepatitis C, Organ Transplantation, Immunosuppression

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Neoral
Tacrolimus
Sponsored by
Duke University
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Hepatitis C

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: adult patients who have received liver transplant Exclusion Criteria: pregnant women nursing women

Sites / Locations

  • Duke University Medical Center

Outcomes

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

Full Information

First Posted
February 2, 2006
Last Updated
September 18, 2014
Sponsor
Duke University
Collaborators
Novartis Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT00286871
Brief Title
Randomized Controlled Trial in Liver Transplant Recipients Treated in Steroid Sparing Regimen
Official Title
Steroid Avoidance in Hep C OLT
Study Type
Interventional

2. Study Status

Record Verification Date
February 2006
Overall Recruitment Status
Completed
Study Start Date
February 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
February 2009 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Duke University
Collaborators
Novartis Pharmaceuticals

4. Oversight

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Hepatitis C, Organ Transplantation, Immunosuppression

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Neoral
Intervention Type
Drug
Intervention Name(s)
Tacrolimus
Primary Outcome Measure Information:
Title
compare timing & severity of recurrent chronic HCV disease Neoral versus Prograf
Secondary Outcome Measure Information:
Title
compare the effectiveness of Neoral with Prograf as primary immunotherapy

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: adult patients who have received liver transplant Exclusion Criteria: pregnant women nursing women
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Devai Desai, MD, PhD
Organizational Affiliation
Duke University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
8596547
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. doi: 10.1056/NEJM199603283341302.
Results Reference
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PubMed Identifier
12619018
Citation
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. doi: 10.1053/jlts.2003.50029.
Results Reference
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PubMed Identifier
12362292
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. doi: 10.1053/jlts.2002.35856.
Results Reference
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PubMed Identifier
9636568
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. doi: 10.1016/s0041-1345(98)00291-7. No abstract available.
Results Reference
background
PubMed Identifier
11510013
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. doi: 10.1053/jlts.2001.26353.
Results Reference
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PubMed Identifier
7308988
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. doi: 10.1002/hep.1840010511.
Results Reference
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Randomized Controlled Trial in Liver Transplant Recipients Treated in Steroid Sparing Regimen

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