AN OPEN, RANDOMISED, MULTICENTRE, CLINICAL STUDY TO COMPARE THE SAFETY AND EFFICACY OF TACROLIMUS AND MINIMAL STEROIDS IN COMBINATION WITH EITHER A MONOCLONAL ANTI-IL2R ANTIBODY (DACLIZUMAB) OR MYCOPH...

Update Il y a 4 ans
Reference: EUCTR2004-001617-34

AN OPEN, RANDOMISED, MULTICENTRE, CLINICAL STUDY TO COMPARE THE SAFETY AND EFFICACY OF TACROLIMUS AND MINIMAL STEROIDS IN COMBINATION WITH EITHER A MONOCLONAL ANTI-IL2R ANTIBODY (DACLIZUMAB) OR MYCOPHENOLATE MOFETIL IN LIVER ALLOGRAFT TRANSPLANTATION

Woman and Man

  • | Country :
  • -
  • | organs :
  • -
  • | Specialty :
  • -

Extract

The objective of this study is to evaluate the efficacy and safety of two regimens (Arm 1 and Arm 2) containing tacrolimus and minimal steroids together with either monoclonal anti-IL2R antibodies (daclizumab) or mycophenolate mofetil. Arm 1: Tacrolimus + MAB (daclizumab) + i.v. steroid bolus peri-op. Arm 2: Tacrolimus + MMF (2g i.v. 3-5 days, 2g p.o. until day 14, thereafter 1g maintenance) + i.v. steroid bolus peri- op.


Inclusion criteria

  • Patients with hepatic disease who will undergo primary orthotopic liver or split liver allograft transplantation