A 24 Month, Multicenter, Open-Label, Randomized, Controlled Study to Evaluate the Efficacy and Safety of Concentration-Controlled Everolimus to Eliminate or to Reduce Tacrolimus Compared to Tacrolimus in de Novo Liver Transplant Recipients

Trial Profile

A 24 Month, Multicenter, Open-Label, Randomized, Controlled Study to Evaluate the Efficacy and Safety of Concentration-Controlled Everolimus to Eliminate or to Reduce Tacrolimus Compared to Tacrolimus in de Novo Liver Transplant Recipients

Completed
Phase of Trial: Phase III

Latest Information Update: 24 Oct 2017

At a glance

  • Drugs Everolimus (Primary) ; Corticosteroids; Mycophenolate mofetil; Tacrolimus
  • Indications Liver transplant rejection
  • Focus Registrational; Therapeutic Use
  • Acronyms RAD
  • Sponsors Novartis Pharma A.G.; Novartis Pharmaceuticals
  • Most Recent Events

    • 24 Oct 2017 Pooled results assessing long-term clinical outcomes in patients with autoimmune liver diseases from two phase III trials (H2304 and PROTECT; n=23) presented at The Liver Meeting 2017: 68th Annual Meeting of the American Association for the Study of Liver Diseases
    • 15 Aug 2017 Results of post-hoc analysis published in the Transplantation.
    • 10 Aug 2017 The study has been discontinued in Belgium according to European Clinical Trials Database record.
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