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

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

Completed
Phase of Trial: Phase III

Latest Information Update: 29 Apr 2016

At a glance

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

    • 25 Mar 2016 Time frame for primary endpoint changed from 'randomization to month 6 post-transplantation' to 'baseline, week 24'.
    • 01 Dec 2015 Status changed from active, no longer recruiting to completed, according to ClinicalTrials.gov record.
    • 13 Sep 2015 Trial design presented at the 17th Congress of the European Society for Organ Transplantation.
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