Sequential Therapy (FK506 + Monoclonal Anti-IL2R Antibodies + MMF) Versus FK506 With Steroids in Liver TX
- Conditions
- Liver Transplantation
- Interventions
- Registration Number
- NCT00693524
- Lead Sponsor
- Astellas Pharma Inc
- Brief Summary
Study to evaluate the benefits and any risks of the delayed administration of tacrolimus in a combined regimen of mycophenolate mofetil and monoclonal anti-IL2R antibodies (daclizumab), in comparison with a standard steroid + tacrolimus double drug regimen
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 94
- Patient is undergoing orthotopic liver allograft transplantation. This includes partial organ transplantation. Age of donor between 5 and 65 years
-
Patient has previously received or is receiving an organ transplant (including liver re-transplantation)
-
Recipient of an auxiliary graft or in which a bio-artificial liver has been used
-
Patient is receiving a living related liver transplantation
-
Patient is requiring steroids as well as chemotherapy prior to transplantation
-
Patient having any previous history of neoplastic disease of any type (including leukaemia). However, patients with primary liver carcinoma can be included if they meet the following criteria:
- > 3 nodes
- No node larger than 5 cm
- No metastases
- No vascular invasion
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1 Mycophenolate mofetil Tacrolimus + Anti-IL2R AB + Mycophenolate mofetil 1 Anti-IL2R AB Tacrolimus + Anti-IL2R AB + Mycophenolate mofetil 1 tacrolimus Tacrolimus + Anti-IL2R AB + Mycophenolate mofetil 2 tacrolimus Tacrolimus + Steroid 2 prednisone Tacrolimus + Steroid
- Primary Outcome Measures
Name Time Method Incidence of first acute rejection 3 months
- Secondary Outcome Measures
Name Time Method Overall frequences of acute rejection episodes 3 months