Liver Dysfunction Clinical Trial
Official title:
Influence of CYP3A5 Polymorphism on Liver Function Abnormality and the Trough Level Change After Conversion From Tacrolimus (Bid) to Advagraf® (qd) in Stable Liver Transplant Recipients
This study is a multicenter, single-arm, open-label, 24 weeks, and investigator-initiated clinical trial to assess the influence of CYP3A5 polymorphism on liver function abnormality and the trough level change after conversion to Advagraf® in liver transplant recipients.
All subjects who are liver transplant recipients taking Tacrolimus bid and adaptable to be
registered for the study will be classified by expressive or non-expressive CYP3A5
polymorphism genotype and Advagraf® will be administered same dose as Tacrolimus bid der day
in 24 weeks.
All subjects should check whether being registered in the hospital based on CYP3A5
polymorphism genotype during screening visit. Registered subjects will visit seven times to
the hospital during the study which includes screening visit and adverse reaction, acute
rejection, and trough level will be tested during this period. Subjects who are additionally
agreed for PK study will be hospitalized with the state of Tacrolimus bid therapy one day
ago before taking IP. On the first day of hospitalization, his/her blood will be collected.
At week 1 (plus seven days) after conversion to Advagraf®, his/her blood will be collected
for PK analysis.
;
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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