Efficacy and Safety of Everolimus in Liver Transplant Recipients of Living Donor Liver Transplants

Efficacy and Safety of Everolimus in Liver Transplant Recipients of Living Donor Liver Transplants

Brief Summary:
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.

Detailed Description:
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).


Study Type: Interventional (Clinical Trial)
Actual Enrollment: 285 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: This was a 24-month, multicenter, open-label, randomized, controlled study. It included the extension to the 24-month, randomized, controlled, open-label CRAD001H2307 study in recipients of living donor liver transplants in Japan.
Masking: Single (Care Provider)
Primary Purpose: Treatment
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
Actual Study Start Date: September 25, 2013
Actual Primary Completion Date: October 19, 2016
Actual Study Completion Date: April 21, 2018

Arm:
- Experimental: Everolimus + reduced tacrolimus
- Active Comparator: Standard tacrolimus

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