Status:
UNKNOWN
Efficacy and Safety of Everolimus Versus Mycophenolate Mofetil in Liver Transplant Recipients.
Lead Sponsor:
Chong Kun Dang Pharmaceutical
Conditions:
Liver Transplant
Eligibility:
All Genders
20+ years
Phase:
PHASE4
Brief 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.
Detailed 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...
Eligibility Criteria
Inclusion
- \* 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 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
Exclusion
Key Trial Info
Start Date :
June 30 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 17 2022
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT04471441
Start Date
June 30 2020
End Date
November 17 2022
Last Update
July 15 2020
Active Locations (1)
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1
Severance Hospital
Seoul, South Korea