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 States, Canada, Egypt285 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 range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
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