Liver Transplantation Clinical Trial
Official title:
A 24 Month, Randomized, Controlled, Study to Evaluate the Efficacy and Safety of Concentration-controlled Everolimus Plus Reduced Tacrolimus Compared to Standard Tacrolimus in Recipients of Living Donor Liver Transplants and Long Term Extension to Evaluate the Efficacy and Safety of Concentration-controlled Everolimus Plus Reduced Tacrolimus Compared to Standard Tacrolimus in Recipients of Living Donor Liver Transplants in Japan
The purpose of this trial was to demonstrate the efficacy and safety of everolimus in combination with reduced tacrolimus, compared to tacrolimus control, in living donor liver transplant recipients.
This study was 24 month, multicenter study in 280 living donor liver transplant patients from
Asia, Europe and Canada. The study has an long term extension in Japan and approximately 28
patients were to be included to evaluate the long-term efficacy and safety of
concentration-controlled everolimus regimen plus reduced tacrolimus compared to standard
tacrolimus in recipients of living donor liver transplants in Japan who participated in the
CRAD001H2307 study.
Data reported here are the CRAD001H2307 core study results and its extension
(CRAD001H2307E1).
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