Efficacy, Safety and Tolerability of Everolimus in Combination With Reduced Exposure Cyclosporine or Tacrolimus in Paediatric Liver Transplant Recipients.

Study is active and ongoing but no longer recruiting since December 2014. The study Data
Monitoring Committee meeting communicated to Novartis safety findings in the group of
children younger than 7 years of age: high rate of premature discontinuation of study
medication, high rate of post-transplant lymphoproliferative disease and high rate of
related serious infections leading to hospitalization. In light of the safety findings,
Novartis followed the DMC recommendation to discontinue the study medication in this age
group and to stop enrolling new patients in this study (regardless of age).

Key Inclusion Criteria:

Signed informed consent from both parents or legal guardian(s) prior to patient
participation in the study.

Paediatric liver transplant recipients aged greater than or equal to 1 month and younger
than 18 years of age.

Paediatric recipients at the earliest 1 month and latest 6 month after liver
transplantation.

Key Exclusion Criteria:

Patients with hepato-biliary malignancies and/or patients transplanted due to fulminant
hepatitis /acute liver failure.

Presence of thrombosis of any major hepatic arteries, major/reconstructed hepatic veins,
portal vein or inferior vena cava at any time prior to the start of study drug.

Patients with serum creatinine value >2 times age-related ULN at Baseline or who received
renal replacement therapy within one week prior to the start of study drug and patients
with a confirmed spot urine protein/creatinine ratio indicating a urinary protein
excretion >500 mg/m2/24 hrs, at Baseline.

Patients with clinically significant systemic infection and/or in a critical care setting
requiring life support measures such as mechanical ventilation, dialysis, or vasopressor
agents.

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

Pregnant or nursing (lactating) female patients, where pregnancy is defined as the state
of a female after conception and until the termination of gestation, confirmed by a
positive βHCG laboratory test (>9 mIU/mL) at Baseline.

Female patients of child-bearing potential, defined as all women physiologically capable
of becoming pregnant, UNLESS they agree for abstinence from sexual activity.