Efficacy and Safety of Everolimus Versus Mycophenolate Mofetil in Liver Transplant Recipients.

  • STATUS
    Recruiting
  • End date
    Nov 17, 2022
  • participants needed
    150
  • sponsor
    Chong Kun Dang Pharmaceutical
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Updated on 24 January 2021
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everolimus
mycophenolate
blood concentration
living donor liver transplant

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.

Description

This study is multi-center, open-label, randomized controlled phase 4 study to evaluate the efficacy and safety of certirobell tablet compared with mycophenolate mofetil in primary living donor liver transplant recipients.

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.

Details
Condition Liver transplant, Liver Transplantation
Treatment Everolimus Tab., Mycophenolate mofetil Tab./Cap.
Clinical Study IdentifierNCT04471441
SponsorChong Kun Dang Pharmaceutical
Last Modified on24 January 2021

Eligibility

 Yes No Not Sure

Inclusion Criteria

Is your age greater than or equal to 20 yrs?
Gender: Male or Female
Do you have any of these conditions: Liver transplant or Liver Transplantation?
Do you have any of these conditions: Liver Transplantation or Liver transplant?
[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 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
Clear my responses
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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