A Multicentre, Randomised, Double Blind, Two Arm Parallel Group Study to Evaluate and Compare the Efficacy and Safety of Modified Release Tacrolimus FK506E (MR4) Versus Tacrolimus FK506 in Combination With Steroids in Patients Undergoing Primary Liver Transplantation

Trial Profile

A Multicentre, Randomised, Double Blind, Two Arm Parallel Group Study to Evaluate and Compare the Efficacy and Safety of Modified Release Tacrolimus FK506E (MR4) Versus Tacrolimus FK506 in Combination With Steroids in Patients Undergoing Primary Liver Transplantation

Completed
Phase of Trial: Phase III

Latest Information Update: 12 Mar 2017

At a glance

  • Drugs Tacrolimus (Primary) ; Corticosteroids
  • Indications Liver transplant rejection
  • Focus Therapeutic Use
  • Sponsors Astellas Pharma
  • Most Recent Events

    • 12 Mar 2017 Results of the pharmacokinetic sub-study (n=25) published in the Clinical Transplantation
    • 14 Aug 2008 Primary endpoint 'Biopsy proven acute transplant rejection' has been met.
    • 14 Aug 2008 Results presented at ICTS 2008.
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