Efficacy and Safety of CertiroBell® Tablet Plus Tacrolimus in Primary Living Donor Liver Transplant Recipients
NCT ID: NCT04867720
Last Updated: 2021-04-30
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
112 participants
INTERVENTIONAL
2021-03-16
2023-02-22
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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CertiroBell Tablet
Use in combination with Tacrolimus at least 6 months after liver transplantation.
Everolimus
\- Oral intake, BID - After first dose 1mg(total 2mg daily), check the blood concentration of everolimus at each visit and adjust the dose to achieve the blood concentration maintaining at 3\~8mg/mL.
Interventions
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Everolimus
\- Oral intake, BID - After first dose 1mg(total 2mg daily), check the blood concentration of everolimus at each visit and adjust the dose to achieve the blood concentration maintaining at 3\~8mg/mL.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Over 20 years old
3. Patients who are being treated with Tacrolimus at screening visit
4. Patients who agreed to written informed consent
Exclusion Criteria
2. Patients who had auxiliary partial orthotopic liver transplantation or had bioartifical liver
3. Patients who have been diagnosed with acute rejection within 6 months and have been treated
4. Patients who had hepatic artery complication such as hepatic artery thrombosis within recent 6 months
5. 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
6. Patients with severe systemic infection
7. Patients who are difficult to communicate due to mental disorder
8. 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
9. 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
10. Patients taking HCV(hapatitis C virus) therapeutic drug or anti-HCV positive patients who have positive result in HCV RNA test at screening visit
11. Patients who had plasmapheresis within 1 week
12. Those who are pregnant, nursing, or are not practicing contraception with appropriate method
13. Patients who had plasmapheresis within 3 months
14. if participated in other trail within 4 weeks(28 days)
15. 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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Kyung-Suk Suh, M.D., Ph.D.
Role: STUDY_CHAIR
Seoul National University Hospital
Locations
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Seoul National University Hosipital
Seoul, , South Korea
Countries
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Central Contacts
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Facility Contacts
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Kyung-Suk Suh, M.D.,Ph.D.
Role: primary
Other Identifiers
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B95_03LT2001
Identifier Type: -
Identifier Source: org_study_id