Status:
COMPLETED
To Evaluate the Efficacy and Safety of ADVAGRAF® After Treatment With a Tacrolimus in New Liver Transplant Recipients
Lead Sponsor:
Kim, Seoung-Hoon
Collaborating Sponsors:
Astellas Pharma Korea, Inc.
Linical Korea
Conditions:
Liver Transplantation
Eligibility:
All Genders
20+ years
Phase:
PHASE4
Brief Summary
This study's objective is to evaluate the incidence rate of acute rejection reactions after 24 weeks treatment with ADVAGRAF® following 3 months treatment with tacrolimus in new liver transplant recip...
Detailed Description
This is single center,open-label study with ADVAGRAF® Primary endpoint is Incidence rate of biopsy confirmed acute rejection reactions within 24 weeks following conversion+ Incidence rate of acute rej...
Eligibility Criteria
Inclusion
- When the Subjects agree informed consent form, Subject should be More than 20 years of age
- Those who was transplanated liver at a minimum of 10 weeks or Maximum of 14 weeks before the baseline
- Average of tacrorimus minimum blood concenration level is 3-10 ng/mL from transplanted date to baseline.
- Female subjects who have child bearing potential must have a negative at urine or serum pregnancy test prior to enrollment and must agree to practice effective contraceptive measures during the study.(The oral contraceptive pill is not allowed to take a female subject)
- Subjects who are clinically stable judged by 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 previously received an organ transplantation excluding liver transplantation. Or Subjects received an auxiliary graft or bioartificial liver(cell system).
- Recently there was acute rejection from the day of liver transplantation to baseline
- If the onset of a new malignant cancer after liver transplantation is diagnosed, well treated basal cell carcinoma or squamous cell carcinoma is classified as an exception
- When it is known that there is a hypersensitivity reaction to the ingredients of tacrolimus or the test drug
- In the opinion of the investigator, there is an unstable medical condition that can affect the purpose of the clinical trial
- In the event of material abuse, mental disorder or anything that can not smoothly communicate with the inverstigator in the opinion of the investigator
- Currently, if subjects are participating in other clinical trials or if subjects receive another drug for clinical trials within 28 days before baseline
- If subjects have received a prohibited combination therapy currently or within 28 days before the baseline
- Pregnant or lactating women
- If known for HIV-positive
- When there is a high possibility that subject will not be able to obey the visit schedule planned in protocol
- Those who have clinically significant renal dysfunction judged by the investigator or at baseline serum creatinine level exceeds 1.6 mg / dL or GFR (MDRD) is less than 30 mL / min
- Those who have clinically significant liver function disorder judged by the investigator or at the baseline, the values of SGPT / ALT and / or SGOT / AST and / or bilirubin are more than three times the upper limit of the laboratory normal range When raised
Key Trial Info
Start Date :
March 22 2016
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 14 2017
Estimated Enrollment :
31 Patients enrolled
Trial Details
Trial ID
NCT03423225
Start Date
March 22 2016
End Date
December 14 2017
Last Update
February 6 2018
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