Please select the eligibility criteria that correspond to the clinical trial below.
Title: A 24 Month, Multicenter, Open-label, Randomized, Controlled Study to Evaluate the Efficacy and Safety of Concentration-controlled Everolimus to Eliminate or to Reduce Tacrolimus Compared to Tacrolimus in de Novo Liver Transplant Recipients
Brief Summary: This trial was designed to address important issues that impact recipients of liver allografts as well as clinicians, ie, renal function, reduction or discontinuation of tacrolimus early post-transplantation, and progression rate of fibrosis in hepatitis C virus (HCV) positive patients.


Options:
A: Inclusion Criteria:

* Age \> 18 years
* Recipient of a primary liver graft
* Absence of any of our exclusion criteria

Exclusion Criteria:

* Pretransplant renal failure, defined as serum creatinine \> 1.5 mg/dL
* Severe pretransplant thrombopenia, defined as platelets \< 50000/mL
* Combined liver-kidney transplantation
* Autoimmune hepatitis, primary biliary cirrhosis or primary sclerosing cholangitis as causes of liver transplantation
* Chronic hepatic encephalopathy
* Living donor liver transplantation
* Recipient with human immunodeficiency virus infection
* Severe pretransplant leukopenia, defined as \< 1500 leukocytes/mL
B: Inclusion criteria:

Male or female recipients of a full-size liver allograft, aged 18 to 65 years.

Exclusion criteria:

Patients with thrombocytopenia (platelets \<50,000/mm³), with an absolute neutrophil count of \<1,000/mm³ or leucopenia (leucocytes \<2000/mm³), with anemia with Hb \< 6g/dl at time of randomization

Patients with uncontrolled hypercholesterolemia (\>350mg/dL; \>9mmol/L) or hypertriglyceridemia (\>750 mg/dL; \>8.5 mmol/L) at time of randomization

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
C: 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.
D: Inclusion Criteria:

1. Age 18 years and older
2. Histologically proven HCC before randomisation
3. Signed, written informed consent

Exclusion Criteria:

1. Multiple-organ recipients.
2. Known hypersensitivity to sirolimus or its derivatives.
3. Hyperlipidemia refractory to optimal medical management. (cholesterol \>300 mg/dL; triglycerides \>350 mg/dL).\*
4. Evidence of significant local or systemic infection.
5. Known HIV-positive patients.\*
6. Platelets \<75,000/cubic mm.\*
7. Women of child-bearing potential not willing to take contraception.
8. Patients with non-HCC malignancies within the past 5 years,excluding successfully treated squamous cell carcinoma and basal cell carcinoma of the skin.
9. Extrahepatic HCC tumor manifestation
10. Patients with a psychologic, familial, sociologic or geographic condition potentially hampering compliance with the study protocol and follow-up schedule.
11. Patients under guardianship (e.g. individuals who are not able to freely give their informed consent).

Answer: C