Ignite Creation Date:
2024-05-06 @ 8:29 AM
Last Modification Date:
2024-10-26 @ 12:00 PM
Study NCT ID:
NCT02747654
Status:
UNKNOWN
Last Update Posted:
2016-04-22
First Post:
2016-04-19
Brief Title:
Isoniazid Dosage Prediction Model Development
Sponsor:
Samsung Medical Center
Organization:
Samsung Medical Center
Study Overview
Official Title:
Development of a Dosing Model Based on Anti-tuberculosis Drug Monitoring NAT2 Genotypes in Tuberculosis Patients
Status:
UNKNOWN
Status Verified Date:
2016-04
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:
Isoniazid INH is an essential component of first-line anti-tuberculosis TB treatment However treatment with INH is complicated by polymorphisms in the expression of the enzyme system primarily responsible for its elimination N-acetyltransferase 2 NAT2 and its associated hepatotoxicity The objective of this study was to develop an individualized INH dosing regimen using a pharmacogenetic-driven model and to apply this regimen in a pilot study
Detailed Description:
None
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