Efficacy and Safety of Everolimus Versus Mycophenolate Mofetil in Liver Transplant Recipients. (NCT04471441) | Clinical Trial Compass
CompletedPhase 4
Efficacy and Safety of Everolimus Versus Mycophenolate Mofetil in Liver Transplant Recipients.
South Korea150 participantsStarted 2020-06-30
Plain-language summary
The purpose of this study is to evaluate the efficacy and safety of CertiroBell® tablet compared with mycophenolate mofetil in primary living donor liver transplant recipients.
Who can participate
Age range
20 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:
\[Time of screening\]
* Patients who have transplanted in primary living donor liver in 35 days or who plan to be transplanted in primary living donor liver.
* Over 20 years old(male or female)
* Agreement with written informed consent
\[Time of randomization\] - Patients who have transplanted liver within 4 weeks(25 days to 35 days)
\* Exclusion Criteria
\[Time of screening\]
* Patients who have transplanted non-liver organs or have plan to be transplanted non-liver organs.
* Patients with bioartificial liver (cell system)
* Patients who diagnosed with malignant tumor within 5 years \[however, who have recovered from skin cancer (squamous cell/basal cell carcinoma) or thyroid cancer, hepatocellular carcinoma without main vessel invasion or extrahepatic metastasis can be enrolled\]
* Patients with severe systemic infection
* Women who are pregnant or breast feeding or not agree to the proper use of contraception during the trial
* Participated in other trial within 4 weeks
* In investigator's judgement
\[Time of randomization\]
* Patients with acute rejection who have been clinically treated after liver transplantation.
* Patients with complication related to the hepatic artery such as hepatic artery thrombosis at the time of randomization.
* At screening
* WBC \<1,500/mm\^3 or PLT \<30,000/mm\^3 or over 3 times upper than normal range of liver function tests(T-bilirubin, AST, ALT) levels
* Protein/Creatinine ratio(urine test) \> 1 or eGFR …
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.