Efficacy and Safety of Everolimus in Liver Transplant Recipients of Living Donor Liver Transplants (NCT01888432) | Clinical Trial Compass
CompletedPhase 3
Efficacy and Safety of Everolimus in Liver Transplant Recipients of Living Donor Liver Transplants
United States285 participantsStarted 2013-09-25
Plain-language summary
The purpose of this trial was to demonstrate the efficacy and safety of everolimus in combination with reduced tacrolimus, compared to tacrolimus control, in living donor liver transplant recipients.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria:
* Written informed consent
* Subject aged ≥18 years of a primary, orthotopic liver allograft, from a living donor
* Subject negative for HIV
Incusion criteria at Randomization:
\- Subject was initated on tacrolimus-based immunosuppressive regimen with steroids and other immunosuppression
Exclusion criteria:
* Subjects transplanted for acute liver failure
* HCV negativesubjects receiving a transplant from HCV positive donor
* Subjects receiving multiple solid organ (including multiple liver lobes/segments) or islet cell tissue transplants, or have previously received an organ or tissue transplant.
* Subjects receiving an ABO incompatible allograft.
* MELD-score \> 35 within 1 month prior to transplantation.
* Use of immunosuppressive or antibody induction agents not specified in the protocol.
* History of malignancy of any organ system (except hepatocellular carcinoma or localized basal cell carcinoma of the skin)
* Hepatocellular carcinoma with extrahepatic spread or macrovascular invasion
* Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test.
* Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception during dosing and for 2 weeks after the last dose of study medication
* History of hypersensitivity to any o…
What they're measuring
1
Number of Participants With Composite Efficacy Failure of Treated Biopsy Proven Acute Rejection, Graft Loss or Death in Everolimus With Reduced Tacrolimus Group Compared to Standard Tacrolimus