Ignite Creation Date:
2024-05-06 @ 8:16 AM
Last Modification Date:
2024-10-26 @ 11:58 AM
Study NCT ID:
NCT02707822
Status:
UNKNOWN
Last Update Posted:
2016-03-14
First Post:
2016-03-09
Brief Title:
The Influence of ABCB1CYP3A4CYP3A5POR Genetic Polymorphism and Other Factors on Tacrolimus Blood Concentration
Sponsor:
National Taiwan University Hospital
Organization:
National Taiwan University Hospital
Study Overview
Official Title:
The Influence of ABCB1CYP3A4CYP3A5POR Genetic Polymorphism and Other Factors on Tacrolimus Blood Concentration
Status:
UNKNOWN
Status Verified Date:
2016-03
Last Known Status:
RECRUITING
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:
None
Brief Summary:
The purpose of the study is to identify factors that may influence tacrolimus TAC pharmacokinetics and the impact of gene polymorphism ABCB1 CYP3A4 CYP3A5 POR on pharmacokinetics of TAC in Taiwanese
Detailed Description:
TAC is one of the most important immunosuppressive agents for organ transplantation In some patients the dose and concentration of TAC are difficult to adjust because of its narrow therapeutic index and variable pharmacokinetics
Many factors affect the pharmacokinetics of TAC Literature suggests that ABCB1 CYP3A4 CYP3A5 POR gene polymorphisms may affect the pharmacokinetics of TAC In addition the distribution of TAC is affected by hematocrit and albumin concentrations The pharmacokinetics of TAC may also be affected by total protein total bilirubin creatinine AST ALT gender age drug interactions and so on
This study intends to analyze the influence of various factors including drugs on the pharmacokinetics of TAC
Many factors affect the pharmacokinetics of TAC Literature suggests that ABCB1 CYP3A4 CYP3A5 POR gene polymorphisms may affect the pharmacokinetics of TAC In addition the distribution of TAC is affected by hematocrit and albumin concentrations The pharmacokinetics of TAC may also be affected by total protein total bilirubin creatinine AST ALT gender age drug interactions and so on
This study intends to analyze the influence of various factors including drugs on the pharmacokinetics of TAC
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