Ignite Creation Date:
2024-05-06 @ 3:48 PM
Last Modification Date:
2024-10-26 @ 1:57 PM
Study NCT ID:
NCT04761731
Status:
COMPLETED
Last Update Posted:
2021-02-21
First Post:
2021-02-17
Brief Title:
To Evaluate the Efficacy and Safety of ADVAGRAF After Treatment With a Tacrolimus in New Liver Transplant Recipients
Sponsor:
Linical Korea
Organization:
Linical Korea
Study Overview
Official Title:
A Single Center Single Arm Open-label Study to Evaluate the Efficacy and Safety of Tacrolimus Modified Release ADVAGRAF After Treatment With a Tacrolimus in New Liver Transplant Recipients
Status:
COMPLETED
Status Verified Date:
2021-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Assign
Brief Summary:
This studys 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
Treatment conversion will take place from twice daily tacrolimus to once daily tacrolimus ADVAGRAF 3 months after transplant in new liver transplant recipients
Detailed Description:
This is single centeropen-label study with ADVAGRAF Primary endpoint is Incidence rate of biopsy confirmed acute rejection reactions within 24 weeks following conversion Incidence rate of acute rejection reactions number of subjects with at least one acute rejection reaction 1total number of subjects in the relevant analysis set 100 Only those acute rejection reactions confirmed by biopsy will be acceptable as acute rejection reactions
Administration method is following The total daily dose of tacrolimus will be converted to 11 mgmg 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 11 It is recommended to check the blood concentration of tacrolimus at each visit and adjust the dose to achieve the blood concentration maintaining at 58ngml for 0 to 3 months and then at 5ngml or below for 3 to 6 months of study treatment
Duration of treatment The investigational product will be administered for 24 weeks
Administration method is following The total daily dose of tacrolimus will be converted to 11 mgmg 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 11 It is recommended to check the blood concentration of tacrolimus at each visit and adjust the dose to achieve the blood concentration maintaining at 58ngml for 0 to 3 months and then at 5ngml or below for 3 to 6 months of study treatment
Duration of treatment The investigational product will be administered for 24 weeks
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None