Efficacy and Safety of CertiroBell® Tablet Plus Tacrolimus in Primary Living Donor Liver Transpla… (NCT04867720) | Clinical Trial Compass
UnknownPhase 4
Efficacy and Safety of CertiroBell® Tablet Plus Tacrolimus in Primary Living Donor Liver Transplant Recipients
South Korea112 participantsStarted 2021-03-16
Plain-language summary
To evaluate the efficacy and safety of CertiroBell® tablet plus tacrolimus
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
. Patients who had liver transplantation from living donor and had passed over 3 months since operation.
. Over 20 years old
. Patients who are being treated with Tacrolimus at screening visit
. Patients who agreed to written informed consent
Exclusion criteria
. Patients who had received non-liver organs before liver transplantation or had received other organs while receiving liver.
. Patients who had auxiliary partial orthotopic liver transplantation or had bioartifical liver
. Patients who have been diagnosed with acute rejection within 6 months and have been treated
. Patients who had hepatic artery complication such as hepatic artery thrombosis within recent 6 months
. Patients who have been diagnosed with malignant tumor within 5 years(however, the following will be excepted)
. Patients with severe systemic infection
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.
. Patients who are difficult to communicate due to mental disorder
. Patients who are in treatment for hapatitis, or are over 3 times higher than upper normal limit in liver function test(T-bilirubin, AST, ALT) or over 5 times higher than normal limit of ALP