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A National, Multi-center, Randomized, Open Label Study to Evaluate the Efficacy and Safety of Everolimus Combined With Enteric-coated Mycophenolate Sodium Compared to the Standard Treatment Combining Tacrolimus and Enteric-coated Mycophenolate Sodium in de Novo Liver Transplant Recipients

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Trial Profile

A National, Multi-center, Randomized, Open Label Study to Evaluate the Efficacy and Safety of Everolimus Combined With Enteric-coated Mycophenolate Sodium Compared to the Standard Treatment Combining Tacrolimus and Enteric-coated Mycophenolate Sodium in de Novo Liver Transplant Recipients

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 17 Sep 2021

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At a glance

  • Drugs Everolimus (Primary) ; Basiliximab; Corticosteroids; Mycophenolate sodium; Tacrolimus
  • Indications Liver transplant rejection
  • Focus Pharmacodynamics; Registrational
  • Acronyms SIMCER
  • Sponsors Novartis Pharmaceuticals

    • Most Recent Events

    • 30 Jan 2017 Results published in the American Journal of Transplantation
    • 17 Apr 2016 Primary endpoint (Change From Baseline (Randomization) in Renal Function) has been met, according to the results presented at The International Liver Congress™ 2016
    • 17 Apr 2016 Results presented at The International Liver Congress 2016
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