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A MULTICENTRE, 1:1 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 COMBINA...

Update Il y a 4 ans
Reference: EUCTR2004-000306-46

A MULTICENTRE, 1:1 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

Woman and Man

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Extract

To evaluate and to compare efficacy and safety of a dual regimen with oral modified release tacrolimus FK506E (MR4) / steroids versus a dual regimen with oral tacrolimus FK506 / steroids in patients undergoing primary liver transplantation. It shall be demonstrated that FK506E (MR4) is non-inferior to FK506 with regards to the primary endpoint.

Inclusion criteria

  • Patients undergoing primary liver transplantation

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