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A 12 Month, Multi-center, Open-label, Randomized, Controlled Study to Evaluate Efficacy/Safety and Evolution of Renal Function of Everolimus in Co-exposure With Tacrolimus in de Novo Liver Transplant Recipients

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Trial Profile

A 12 Month, Multi-center, Open-label, Randomized, Controlled Study to Evaluate Efficacy/Safety and Evolution of Renal Function of Everolimus in Co-exposure With Tacrolimus in de Novo Liver Transplant Recipients

Status: Completed
Phase of Trial: Phase IV

Latest Information Update: 20 Sep 2021

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At a glance

  • Drugs Everolimus (Primary) ; Corticosteroids; Tacrolimus
  • Indications Liver transplant rejection
  • Focus Therapeutic Use
  • Acronyms HEPHAISTOS
  • Sponsors Novartis; Novartis Pharmaceuticals
  • Most Recent Events

    • 15 Sep 2021 Primary endpoint (Estimated Glomerular Filtration Rate (GFR)) has been met, as per results published in the Liver Transplantation.
    • 15 Sep 2021 Results assessing effects of early initiation of Everolimus-facilitated reduced tacrolimus exposure (EVR+rTAC) in de novo liver transplant recipients (LTR), published in the Liver Transplantation.
    • 03 Jun 2020 Results assessing discontinuation rates in multicentre trials presented at the 2020 American Transplant Congress
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