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 range20 Years
SexALL
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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 …