Status:
COMPLETED
Evaluate the Efficacy and Safety of the ADVAGRAF®
Lead Sponsor:
Linical Korea
Collaborating Sponsors:
Asan Medical Center
Conditions:
Evidence of Liver Transplantation
Eligibility:
All Genders
19-80 years
Phase:
PHASE4
Brief Summary
The primary objective of this study is to evaluate the efficacy of 6-month treatment with Advagraf® converted from 12-month treatment with tacrolimus in stable liver transplant recipients. The second...
Detailed Description
This is single-center, single-group, open-label study, phase 4 IIT. The Subject is transplantated liver at a minimum of 12 month of screening and at least 12 month Treatment with a Tacrolimus stably A...
Eligibility Criteria
Inclusion
- Aged between 19 and 80 years old
- Those who were transplantated liver at a minimum of 12 month of screening and after 12 month Treatment with a Tacrolimus stably.(Brain dead transplantation or biological transplant no values)
- tacrolimus blood everage level is 3-10 ng/ml for at least 6 months prior to screening.
- Female subjects of child bearing potential must have a negative urine or serum pregnancy test prior to enrollment and at the end of study and must agree to practice effective birth control during the study.
- Subjects are stable clinically in the opinion of the investigator.
- Subjects capable of understanding the purpose and risks of the study, having been fully informed and has given written informed consent to participate in the study
Exclusion
- Subjects having previously received an organ transplant excluding liver transplant. Or Subjects receiving an auxiliary graft or in whom a bio-artificial liver(cell system) has been used.
- Acute rejection confirmed by histologic response or the patient had chronic rejection
- Subjects diagnosed new malignant tumor before the pre-screening within five years , with the exception of basalioma or squamous cell carcinoma or carcinoma in situ of the skin that has been treated successfully.
- Subjects allergic to tacrolimus or investigational product.
- Subjects are unstable clinically state in the opinion of the investigator.
- Subjects with any form of substance abuse, psychiatric disorder or condition which, in the opinion of the investigator, may complicate communication with the investigator.
- Subjects participating or having participated in another clinical trial and/or those taking or having taken an investigational / non-registered drug in the past 28 days.
- Subjects taking forbidden concomitant medications or within 28 days prior to enroll.
- Subjects who are pregnant or breast-feeding mother.
- Subjects unlikely to comply with the visits scheduled in the protocol.
- Subjects with renal dysfunction on the investigator's point of view or serum creatinine \> 1.6mg/dL or GFR(MDRD)\<30mL/min in the baseline.
- Hepatic dysfunction: rising more than double the normal range of SGPT/ALT and/or SGOT/AST and/or bilirubin, hepatic cirrhosis
Key Trial Info
Start Date :
November 1 2016
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2020
Estimated Enrollment :
101 Patients enrolled
Trial Details
Trial ID
NCT04763096
Start Date
November 1 2016
End Date
April 1 2020
Last Update
February 21 2021
Active Locations (1)
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1
Seoul Asan Medical Center
Seoul, South Korea, 05505