Everolimus in de Novo Liver Transplantation: a Multicentre Randomized Study (NCT01423708) | Clinical Trial Compass
UnknownPhase 2
Everolimus in de Novo Liver Transplantation: a Multicentre Randomized Study
Italy117 participantsStarted 2010-02
Plain-language summary
Safety and Efficacy of Everolimus in adult de novo liver transplant recipients.
Who can participate
Age range18 Years – 70 Years
SexALL
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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 tr…