To Evaluate the Efficacy and Safety of ADVAGRAF® After Treatment With a Tacrolimus in New Liver Transplant Recipients

• Status: Completed
• Trial end date: 2017-12-14
• Target enrollment: 0
• Participant gender: All

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 recipients.

Treatment conversion will take place from twice daily tacrolimus to once daily tacrolimus (ADVAGRAF) 3 months after transplant in new liver transplant recipients.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Kim, Seoung-Hoon
• Collaborators: Astellas Pharma Korea, Inc.; Linical Korea
• Treatments: Tacrolimus

Criteria

Inclusion Criteria:

1. When the Subjects agree informed consent form, Subject should be More than 20 years of age

2. Those who was transplanated liver at a minimum of 10 weeks or Maximum of 14 weeks before the baseline

3. Average of tacrorimus minimum blood concenration level is 3-10 ng/mL from transplanted date to baseline.

4. 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)

5. Subjects who are clinically stable judged by investigator.

6. 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 Criteria:

1. Subjects previously received an organ transplantation excluding liver transplantation. Or Subjects received an auxiliary graft or bioartificial liver(cell system).

2. Recently there was acute rejection from the day of liver transplantation to baseline

3. 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

4. When it is known that there is a hypersensitivity reaction to the ingredients of tacrolimus or the test drug

5. In the opinion of the investigator, there is an unstable medical condition that can affect the purpose of the clinical trial

6. In the event of material abuse, mental disorder or anything that can not smoothly communicate with the inverstigator in the opinion of the investigator

7. Currently, if subjects are participating in other clinical trials or if subjects receive another drug for clinical trials within 28 days before baseline

8. If subjects have received a prohibited combination therapy currently or within 28 days before the baseline

9. Pregnant or lactating women

10. If known for HIV-positive

11. When there is a high possibility that subject will not be able to obey the visit schedule planned in protocol

12. 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

13. 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