Status:
UNKNOWN
Efficacy and Safety of CertiroBell® Tablet Plus Tacrolimus in Primary Living Donor Liver Transplant Recipients
Lead Sponsor:
Chong Kun Dang Pharmaceutical
Conditions:
Liver Transplant
Eligibility:
All Genders
20+ years
Phase:
PHASE4
Brief Summary
To evaluate the efficacy and safety of CertiroBell® tablet plus tacrolimus
Detailed Description
This study is multi-center, single arm, open-label, phase 4 study to evaluate the efficacy and safety of CertiroBell® tablet plus tacrolimus in primary living donor liver transplant recipients.
Eligibility Criteria
Inclusion
- 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
- 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)
- fully recovered from skin cancer(squamous cell/basal cell carcinoma or thyroid cancer)
- haptocellular carcinoma without main vessel invasion
- Patients with severe systemic infection
- 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
- Patients who are(at screening visit)
- WBC\<1,500/mm\^3
- PLT\<30,000/mm\^3
- over 1.0 in Protein/creatinine ratio(UA test)
- eGFR\<30mL/min/1.73m\^2(MDRD)
- Total Cholesterol\>350mg/dL or Triglycerides\>500mg/dL
- Patients taking HCV(hapatitis C virus) therapeutic drug or anti-HCV positive patients who have positive result in HCV RNA test at screening visit
- Patients who had plasmapheresis within 1 week
- Those who are pregnant, nursing, or are not practicing contraception with appropriate method
- Patients who had plasmapheresis within 3 months
- if participated in other trail within 4 weeks(28 days)
- In investigator's judgement
Key Trial Info
Start Date :
March 16 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 22 2023
Estimated Enrollment :
112 Patients enrolled
Trial Details
Trial ID
NCT04867720
Start Date
March 16 2021
End Date
February 22 2023
Last Update
April 30 2021
Active Locations (1)
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1
Seoul National University Hosipital
Seoul, South Korea