Liver Transplantation
Conditions
Keywords
liver allograft transplantation, sequential therapy, tacrolimus
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
Interventions
DRUGtacrolimus
oral
DRUGAnti-IL2R AB
i.v.
DRUGMycophenolate mofetil
oral
DRUGprednisone
oral
Sponsors
Astellas Pharma Inc
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patient is undergoing orthotopic liver allograft transplantation. This includes partial organ transplantation. Age of donor between 5 and 65 years
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of first acute rejection | 3 months |
Secondary
| Measure | Time frame |
|---|---|
| Overall frequences of acute rejection episodes | 3 months |
Countries
Italy
Outcome results
None listed