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A MULTICENTER, OPEN, SINGLE SEQUENCE CROSSOVER STUDY TO ASSESS THE SAFETY AND EFFICACY OF A TACROLIMUS MODIFIED RELEASE, FK506E (MR4), BASED IMMUNOSUPPRESSIVE REGIMEN IN STABLE LIVER TRANSPLANT PATIEN...

Update Il y a 4 ans
Reference: EUCTR2006-000936-28

A MULTICENTER, OPEN, SINGLE SEQUENCE CROSSOVER STUDY TO ASSESS THE SAFETY AND EFFICACY OF A TACROLIMUS MODIFIED RELEASE, FK506E (MR4), BASED IMMUNOSUPPRESSIVE REGIMEN IN STABLE LIVER TRANSPLANT PATIENTS CONVERTED FROM A PROGRAF BASED IMMUNOSUPPRESSIVE REGIMEN

Woman and Man

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Extract

To assess the safety of a tacrolimus modified release, MR4 , based immunosuppressive regimen in stable liver transplant subjects converted on a 1:1 (mg:mg) basis from a Prograf® based immunosuppressive regimen. Non-inferiority for creatinine clearance will be assessed.

Inclusion criteria

  • Stable, adult liver transplant recipients (≥ 12 months post transplant) who are currently treated with Prograf

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