To compare the safety and efficacy of Prograf® with Myfortic® to Advagraf® extended release tacrolimus with Myfortic® in de novo liver transplant recipients.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
44
Unnamed facility
Taichung, Taiwan
Unnamed facility
Tainan, Taiwan
Unnamed facility
Taipei, Taiwan
Incidence of biopsy confirmed acute rejection
Time frame: during the 6 months post-transplant.
Patient and graft survival rates
Time frame: during the 6 months post-transplant
Time to first biopsy confirmed acute rejection episode
Time frame: during the 6 months post-transplant
Incidence of anti-lymphocyte antibody therapy for treatment of rejection
Time frame: during the 6 months post-transplant.
Safety assessed by adverse events, laboratory parameters, physical examinations and vital signs
Time frame: throughout the study
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