Liver Transplantation
Conditions
Keywords
Liver Transplantation, Tacrolimus, Methylprednisolone, Prednisolone
Brief summary
The patients about to undergo liver transplantation will be randomized to one of the following two group: Group FK506MR: FK506MR/steroid; Group Prograf® : Prograf® /steroid The treatment period is 3 months(12 weeks
Interventions
oral
DRUGPrograf
oral
Sponsors
Astellas Pharma Inc
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Written informed consent with the date of the patient must be obtained. * Patient between 18-70 years of age receiving the primary liver. * Female patients must have a negative pregnancy test prior to the enrolment. * Female patients of child bearing potential must agree to practice effective birth control during the study
Exclusion criteria
* Liver re-transplantation patients or received an organ transplantation other than a liver. * Living-related liver transplantation patient. * Patient has received an AB0 incompatible donor liver. * Patient who needs antibody induction therapy. * Patient with sever infection requiring treatment. * Patient has any history of severe cardiovascular, respiratory disease; or history of malignancy, liver cancer not included.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Event rate of patients with acute rejections | 12 Weeks |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of and time to acute rejections | 12 Weeks |
| Overall frequency of acute rejections | 12 Weeks |
| Rate of patient and graft survival following transplantation. | 12 weeks |
Countries
China
Outcome results
None listed