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

PHASE4CompletedINTERVENTIONAL
Enrollment

31

Participants

Timeline

Start Date

July 31, 2015

Primary Completion Date

December 14, 2017

Study Completion Date

December 14, 2017

Conditions
Liver Transplantation
Interventions
DRUG

ADVAGRAF®

"Administration method The total daily dose of tacrolimus will be converted to 1:1 (mg:mg) and the total daily dose of ADVAGRAF® will be administered only once daily in the morning, starting from Day 1 (at least one hour before breakfast or 2 to 3 hours after breakfast).~* Dose adjustment after conversion On Day 1, the total dose will be converted to 1:1. It is recommended to check the blood concentration of tacrolimus at each visit and adjust the dose to achieve the blood concentration maintaining at 5\~8ng/ml for 0 to 3 months and then at 5ng/ml or below for 3 to 6 months of study treatment.~* Duration of treatment The investigational product will be administered for 24 weeks."

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

Astellas Pharma Korea, Inc.

INDUSTRY

collaborator

National Cancer Center, Korea

OTHER_GOV

lead

Linical Korea

INDUSTRY

NCT04761731 - To Evaluate the Efficacy and Safety of ADVAGRAF® After Treatment With a Tacrolimus in New Liver Transplant Recipients | Biotech Hunter | Biotech Hunter