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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

Trial Profile

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

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 03 Jul 2019

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At a glance

  • Drugs Everolimus (Primary) ; Corticosteroids; Tacrolimus
  • Indications Liver transplant rejection
  • Focus Registrational; Therapeutic Use
  • Sponsors Novartis; Novartis Healthcare; Novartis Pharma KK; Novartis Pharmaceuticals
  • Most Recent Events

    • 13 Nov 2018 Results of a pooled analysis from H2304 and H2307 studies, presented at The Liver Meeting 2018: 69th Annual Meeting of the American Association for the Study of Liver Diseases
    • 06 Jun 2018 24-Month results presented at the 2018 American Transplant Congress
    • 13 Dec 2017 Results published in the American Journal of Transplantation.
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