Liver Transplantation Clinical Trial
Official title:
A Single Center, Single Arm, Open-label Study to Evaluate the Efficacy and Safety of Tacrolimus Modified Release, ADVAGRAF® After Treatment With a Tacrolimus in New Liver Transplant Recipients
This study's objective is to evaluate the incidence rate of acute rejection reactions after
24 weeks treatment with ADVAGRAF® following 3 months treatment with tacrolimus in new liver
transplant recipients.
Treatment conversion will take place from twice daily tacrolimus to once daily tacrolimus
(ADVAGRAF) 3 months after transplant in new liver transplant recipients.
This is single center,open-label study with ADVAGRAF® Primary endpoint is Incidence rate of
biopsy confirmed acute rejection reactions within 24 weeks following conversion+ Incidence
rate of acute rejection reactions (%) = number of subjects with at least one acute rejection
reaction 1)/total number of subjects in the relevant analysis set * 100 Only those acute
rejection reactions confirmed by biopsy will be acceptable as acute rejection reactions.
Administration method is following The total daily dose of tacrolimus will be converted to
1:1 (mg:mg) and the total daily dose of ADVAGRAF® will be administered only once daily in the
morning, starting from Day 1 (at least one hour before breakfast or 2 to 3 hours after
breakfast).
- Dose adjustment after conversion On Day 1, the total dose will be converted to 1:1. It
is recommended to check the blood concentration of tacrolimus at each visit and adjust
the dose to achieve the blood concentration maintaining at 5~8ng/ml for 0 to 3 months
and then at 5ng/ ml or below for 3 to 6 months of study treatment.
- Duration of treatment The investigational product will be administered for 24 weeks.
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