Comparing Efficacy and Safety of Tacrolimus With Steroids or Monoclonal Anti-IL2R Antibody in Hepatitis C Virus (HCV) Positive Liver Transplant Patients

Study Overview
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Brief Summary
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This is an exploratory study to evaluate the impact of eliminating steroid administration upon viral HCV load at 12 months measured by quantitative serum HCV-RNA determination in patients transplanted for HCV cirrhosis.

Detailed Description
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A comparison will be made between two regimens which both include tacrolimus, one utilizing standard steroid administration and the second with daclizumab (MAB) avoiding steroids for both prophylactic administration and anti-rejection treatment.

Official Title
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Comparing Efficacy and Safety of Tacrolimus With Steroids or Monoclonal Anti-IL2R Antibody in HCV Positive in Liver Transplantation

Conditions
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Hepatitis C, Liver Transplantation

Intervention / Treatment
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* Drug: Tacrolimus
* Drug: steroids, monoclonal anti-IL2R antibody


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients 18 to 65 years of age who will undergo primary orthotopic liver or split liver allograft transplantation for HCV-cirrhosis are eligible for the study. Patients receiving a cadaveric liver transplant with compatible ABO blood type can be included. Exclusion Criteria: Recipient of multi-organ transplant Recipient of an auxiliary graft Patient is receiving ABO incompatible graft Patients requiring immunosuppressive treatment Patients requiring ongoing corticosteroid therapy. Patient has significant, uncontrolled concomitant infections and/or severe diarrhoea, vomiting, active upper gastro-intestinal tract malabsorption or active peptic ulcer. Patient or donor is known to be HIV positive. Patient is allergic or intolerant to study medication Patient is pregnant or breast-feeding. Patient has been previously enrolled in this study

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br> | Drug: Tacrolimus<br>* immunosuppression<br>* Other names: Prograf, FK506;Drug: steroids, monoclonal anti-IL2R antibody<br>* immunosuppression<br>|
| Experimental: 2<br> | Drug: Tacrolimus<br>* immunosuppression<br>* Other names: Prograf, FK506;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Viral load of HCV at 12 months post transplantation |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Biopsy-proven acute rejection |  | 12 months | 
| Acute rejection |  | 12 months | 
| Patient and graft survival |  | 12 months | 
| Incidence of adverse events |  | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Tacrolimus, Liver Transplantation, Immunosuppression, Adult, Treatment Outcome