Ignite Creation Date:
2024-05-05 @ 6:58 PM
Last Modification Date:
2024-10-26 @ 9:38 AM
Study NCT ID:
NCT00571753
Status:
TERMINATED
Last Update Posted:
2011-02-28
First Post:
2007-12-11
Brief Title:
Isoniazid Dose Adjustment According to NAT2 Genotype IDANAT2
Sponsor:
University of Cologne
Organization:
University of Cologne
Study Overview
Official Title:
A Double-blind Multicentre Parallel Group Randomised Controlled Trial to Evaluate the Possible Benefit of Isoniazid Dose Adjustment According to the Genotype for NAT2 Arylamine N-acetyltransferase Type 2 in Patients With Pulmonary Tuberculosis
Status:
TERMINATED
Status Verified Date:
2011-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Enrolling participants has halted prematurely due to a low recruitment rate
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The study is conducted to compare safety and efficacy of isoniazid administered as an adjusted dose based on NAT2 arylamine N-acetyltransferase type 2genotype and as a standard dose
The hypothesis is that the genotype-adjusted dose is superior to the standard dose with regard to hepatotoxicity and early treatment failure respectively in the group of slow and rapid acetylators of NAT2
The hypothesis is that the genotype-adjusted dose is superior to the standard dose with regard to hepatotoxicity and early treatment failure respectively in the group of slow and rapid acetylators of NAT2
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| EUDRACT Number2007-000224-41 | None | None | None |