Clinical trial NCT00622869 (phase 3, status: completed)
Conditions: liver transplantation
ICD codes: Z52.6, K71.8, K71.7, A06.4, C22.0, C22.3, K70.0
Drugs: tacrolimus (reduced tacrolimus), tacrolimus (tacrolimus elimination), tacrolimus (tacrolimus control), everolimus (reduced tacrolimus), everolimus (tacrolimus elimination), corticosteroids
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Eligibility criteria:

        Inclusion Criteria:

          -  Ability and willingness to provide written informed consent and adhere to study
             regimen.

          -  Recipients who are 18-70 years of age of a primary liver transplant from a deceased
             donor.

          -  Recipients who have been initiated on an immunosuppressive regimen that contains
             corticosteroids and tacrolimus, 3-7 days post-transplantation.

          -  Confirmed recipient hepatitis C virus (HCV) status at Screening (either by antibody or
             by PCR (polymerase chain reaction).

          -  Allograft is functioning at an acceptable level by the time of randomization as
             defined by protocol specific laboratory values.

          -  Abbreviated Modification of Diet in Renal Disease estimated glomerular filtration rate
             (MDRD eGFR) ≥ 30 mL/min/1.73m2. Results obtained within 5 days prior to randomization
             are acceptable, however, no sooner than Day 25 post-transplantation.

          -  Verification of at least 1 tacrolimus trough level of ≥ 8 ng/mL in the week prior to
             randomization. Investigators should make adjustments in tacrolimus dosing to continue
             to target trough levels above 8 ng/mL prior to randomization.

        Exclusion Criteria

          -  Patients who are recipients of multiple solid organ or islet cell tissue transplants,
             or have previously received an organ or tissue transplant. Patients who have a
             combined liver-kidney transplant.

          -  Recipients of a liver from a living donor, or of a split liver.

          -  History of malignancy of any organ system within the past 5 years whether or not there
             is evidence of local recurrence or metastases, other than non-metastatic basal or
             squamous cell carcinoma of the skin, or HCC (hepatocellular carcinoma) (see next
             criteria).

          -  Hepatocellular carcinoma that does not fulfill Milan criteria (1 nodule ≤ 5 cm, 2-3
             nodules all < 3 cm) at the time of transplantation as per explant histology of the
             recipient liver.

          -  Any use of antibody induction therapy.

          -  Patients with a known hypersensitivity to the drugs used on study or their class, or
             to any of the excipients.

          -  Patients who are recipients of ABO incompatible transplant grafts.

          -  Recipients of organs from donors who test positive for Hepatitis B surface antigen or
             HIV are excluded.

          -  Patients who have any surgical or medical condition, which in the opinion of the
             investigator, might significantly alter the absorption, distribution, metabolism and
             excretion of study drug.

          -  Women of child-bearing potential (WOCBP).

          -  Patients with any history of coagulopathy or medical condition requiring long-term
             anticoagulation which would preclude liver biopsy after transplantation. (Low dose
             aspirin treatment or interruption of chronic anticoagulant is allowed).

        Other protocol-defined inclusion/exclusion criteria may apply.