Comparing Efficacy and Safety of Tacrolimus With Steroids or Monoclonal Anti-IL2R Antibody in Hepatitis C Virus (HCV) Positive Liver Transplant Patients
Phase 2
Completed
- Conditions
- Hepatitis CLiver Transplantation
- Interventions
- Drug: steroids, monoclonal anti-IL2R antibody
- Registration Number
- NCT00295607
- Lead Sponsor
- Astellas Pharma Inc
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 138
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1 Tacrolimus - 1 steroids, monoclonal anti-IL2R antibody - 2 Tacrolimus -
- Primary Outcome Measures
Name Time Method Viral load of HCV at 12 months post transplantation 12 months
- Secondary Outcome Measures
Name Time Method Biopsy-proven acute rejection 12 months Acute rejection 12 months Patient and graft survival 12 months Incidence of adverse events 12 months