Extension Study to Evaluate the Long-term Efficacy and Safety of Everolimus in Liver Transplant Recipients

• Incidence of hypertension, neurotoxicity, or new-onset diabetes mellitus (NODM) [ Time Frame: 36 and 48 months post-transplantation ] [ Designated as safety issue: Yes ]
• Incidence of adverse events (AEs) and serious adverse events (SAEs) [ Time Frame: 36 and 48 months post-transplantation ] [ Designated as safety issue: Yes ]

The reason for this extension is to evaluate the long-term safety and efficacy of two concentration-controlled everolimus regimen in de novo liver transplant recipients. The most important long-term safety assessments include evaluation of renal function, progression of HCV related allograft fibrosis, and other treatment related effects at Month 36 post-transplantation compared to extension baseline (Months 24 post-transplantation).

• Drug: Tacrolimus
• Drug: Tacrolimus + everolimus
• Drug: Everolimus

• Active Comparator: Tacrolimus
  Intervention: Drug: Tacrolimus
• Experimental: Low dose tacrolimus + everolimus
  Intervention: Drug: Tacrolimus + everolimus
• Experimental: Everolimus
  Intervention: Drug: Everolimus

Inclusion Criteria:

• Written informed consent
• Ability and willingness to adhere to study regimen
• Completed core study with assigned regimen

Exclusion Criteria:

Patients fulfilling any of the following criteria are not eligible for inclusion in this study:

• Severe hypercholesterolemia or hypertriglyceridemia.
• Low platelet count.
• Low white blood cell count.
• Positive test for human immunodeficiency virus (HIV).
• Systemic infection requiring active use of IV antibiotics.
• Patients in a critical care setting.
• Use of prohibited medication.
• Use of immunosuppressive agents not utilized in the protocol.
• Hypersensitivity to any of the study drugs or similar drugs.
• Pregnant or nursing (lactating) women
• Women of child-bearing potential not using a highly effective method of birth control.

Other protocol-defined inclusion/exclusion criteria may apply