Efficacy and Safety of Everolimus Versus Mycophenolate Mofetil in Liver Transplant Recipients.
NCT ID: NCT04471441
Last Updated: 2020-07-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
150 participants
INTERVENTIONAL
2020-06-30
2022-11-17
Brief Summary
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Detailed Description
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On the first visit the patients scheduled to be operated liver transplant in 35 days will be conducted screening. Patients who meet the criteria of this clinical trial will be randomized to CertiroBell or mycophenolate mofetil on the second visit. Each group will take CertiroBell or mycophenolate mofetil and will conduct scheduled tests with 5 additional visits.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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CertiroBell Tablet
De novo liver transplant recipients will be randomized after liver transplant operation.
Everolimus Tab.
After first dose 1mg BID(total 2mg daily PO), check the blood concentration of everolimus at each visit and adjust the dose to acheive the blood concentration maintaining at 3\~8ng/mL.
Mycophenolate mofetil Tablet/Capsule
De novo liver transplant recipients will be randomized after liver transplant operation.
Mycophenolate mofetil Tab./Cap.
Up to 1.5g BID(total 3g daily), PO
Interventions
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Everolimus Tab.
After first dose 1mg BID(total 2mg daily PO), check the blood concentration of everolimus at each visit and adjust the dose to acheive the blood concentration maintaining at 3\~8ng/mL.
Mycophenolate mofetil Tab./Cap.
Up to 1.5g BID(total 3g daily), PO
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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 by MDRD\< 30mL/min/1.73m\^2 or Total cholesterol \> 350mg/dL or triglycerides \> 500mg/dL
* Patients taking HCV(hepatitis C virus) Therapeutic Drugs
* Patients who had plasmapheresis within 1 week.
* Patents who had a record of taking mTOR inhibitor before.
* In investigator's judgement
20 Years
ALL
No
Sponsors
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Chong Kun Dang Pharmaceutical
INDUSTRY
Responsible Party
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Principal Investigators
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Soon Il Kim, M.D., Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Severance Hospital
Locations
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Severance Hospital
Seoul, , South Korea
Countries
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Central Contacts
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Other Identifiers
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B95-02LT1903
Identifier Type: -
Identifier Source: org_study_id
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