A 24-month Randomized Multicenter Study Evaluating Efficacy, Safety, Tolerability and Pharmacokinetics of Sotrastaurin and Tacrolimus vs. a Tacrolimus/Mycophenolate Mofetil-based Control Regimen in de Novo Liver Transplant Recipients

Trial Profile

A 24-month Randomized Multicenter Study Evaluating Efficacy, Safety, Tolerability and Pharmacokinetics of Sotrastaurin and Tacrolimus vs. a Tacrolimus/Mycophenolate Mofetil-based Control Regimen in de Novo Liver Transplant Recipients

Discontinued
Phase of Trial: Phase II

Latest Information Update: 14 Aug 2017

At a glance

  • Drugs Sotrastaurin (Primary) ; Immunosuppressants; Mycophenolate mofetil; Tacrolimus
  • Indications Liver transplant rejection
  • Focus Biomarker; Therapeutic Use
  • Sponsors Novartis
  • Most Recent Events

    • 10 Sep 2013 Results presented at the 16th Congress of the European Society for Organ Transplantation.
    • 10 Sep 2013 Primary endpoint 'Treatment-failure-rate' has not been met.
    • 23 Jan 2013 Status changed from active, no longer recruiting to discontinued, based on information in Novartis' Form 20-F (http://www.sec.gov/Archives/edgar/data/1114448/000104746913000377/a2212460z20-f.htm).
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