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Terapia Con Everolimus Nel Trapianto de Novo di Fegato: Uno Studio Multicentrico Randomizzato

Phase 2
18 Years
70 Years
Open (Enrolling)
Liver Failure, Liver Diseases, Liver Cirrhosis, Liver Neoplasms

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Trial Information

Terapia Con Everolimus Nel Trapianto de Novo di Fegato: Uno Studio Multicentrico Randomizzato

This prospective study was designed to evaluate the feasibility and effectiveness of the use
of Everolimus in the minimization and possible suspension of calcineurin inhibitors in adult
liver transplant patients. The study will take into account a control group (standard
immunosuppression with tacrolimus and steroids) after induction with anti-IL2 Antibodies.

Inclusion Criteria:

- Male or female patients between 18 and 70 years of age,

- Patients undergoing de novo liver transplantation from cadaveric donor with a
functional graft at the time of randomization,

- Transplantation from cadaveric donor whole or split liver,

- Patients able to communicate properly with the study investigators, to understand and
respond to the needs of the protocol and who have given written consent

- Cold ischemia time <12 hours

Exclusion Criteria:

- Physical or laboratory abnormalities or mental illness within 2 weeks before
randomization such that, in the opinion of the investigator, may interfere with
participation in the study

- Women who are pregnant (positive test with hCG values> 5mUI/ml) or breast-feeding

- Women of childbearing potential, with the following exceptions: a) women in menopause
(spontaneous amenorrhea for at least 12 months, spontaneous amenorrhea for at least 6
months with FSH levels >40 mIU/ml, surgical bilateral oophorectomy at least 6 weeks
before baseline, with or without hysterectomy) b) women who use one or more reliable
and approved methods of contraception for the duration of the study and for the three
months following discontinuation of study treatment.

- Patients who undergo transplantation or multivisceral transplantation of pancreatic
islets, or who have previously undergone organ transplantation or tissue.

- Patients who undergo combined liver-kidney transplantation

- Patients who undergo living donor liver transplantation

- Patients who undergo ABO-incompatible liver transplantation

- Patients who undergo transplantation from donors positive for HBV surface antigen or

- History of malignant disease at any site in the 3 year period prior, regardless of
whether or not there is evidence of recurrence or metastasis. (Except non-metastatic
skin cancers such as basal cell or squamous cell carcinoma of the skin, or
hepatocellular carcinoma)

- Patients receiving other investigational drugs within 4 weeks before baseline or who
are currently enrolled in other clinical trials

- Patients who show hypersensitivity to the drug (or drugs similar to Everolimus -
Former macrolides) or class or pharmaceutical excipients. Also, when there are

- A history of coagulopathy or the presence of any medical condition that requires
long-term anticoagulant therapy after transplantation (The use of low-dose ASA is

- Platelet count <=40.000/mm3 or WBC count <2000/mm3 or hemoglobin <=7g/dl at the time
of randomization

- Severe systemic infections

- High cholesterol levels (>350mg/dl) or severe hypertriglyceridemia (>500mg/dl).
Patients with compensated hyperlipidemia are eligible.

- Diagnosis of pre-transplant autoimmune liver disease (PBC, sclerosing cholangitis)

- Acute Liver Failure

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Biopsy-proven rejection episodes (BPAR)

Outcome Time Frame:

3 months

Safety Issue:


Principal Investigator

Umberto Cillo, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Azienda Ospedaliera di Padova


Italy: Ethics Committee

Study ID:




Start Date:

February 2010

Completion Date:

January 2014

Related Keywords:

  • Liver Failure
  • Liver Diseases
  • Liver Cirrhosis
  • Liver Neoplasms
  • Liver Transplantation
  • Graft Rejection
  • Graft Survival
  • Transplantation Immunology
  • Anti-Rejection Therapy
  • Immunosuppression
  • Organ Transplantation
  • Host vs Graft Reaction
  • Gastroenterology
  • Hepatology
  • Neoplasms
  • Liver Cirrhosis
  • Fibrosis
  • Liver Diseases
  • Liver Neoplasms
  • Liver Failure