Ignite Creation Date:
2024-05-05 @ 9:12 PM
Last Modification Date:
2024-10-26 @ 10:00 AM
Study NCT ID:
NCT00834353
Status:
COMPLETED
Last Update Posted:
2009-02-03
First Post:
2009-02-02
Brief Title:
Prospective Study of N-acetyltransferase2 NAT2 and Cytochrome P4502E1 CYP2E1 Gene as Susceptible Risk Factors for Antituberculosis ATT Induced Hepatitis
Sponsor:
Maulana Azad Medical College
Organization:
Maulana Azad Medical College
Study Overview
Official Title:
Prospective Study of N-acetyltransferase2 NAT2 Gene and Rifampicin Induced Cytochrome P-450 as Susceptible Risk Factors for Antituberculosis Drug Induced Hepatitis
Status:
COMPLETED
Status Verified Date:
2009-02
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:
None
Brief Summary:
N-acetyltransferase2 NAT2 and Cytochrome P4502E1 CYP2E1 are two drug metabolizing enzymes Antituberculosis drug isoniazid is acetylated by NAT2 and forms ultimately a nontoxic compound which is metabolized by CYP2E1 to a toxic metabolite Slow acetylator genotype of NAT2 and wild type genotype of CYP2E1 gene has been attributed to greater toxicity of ATT drug Therefore this study has been designed to analyze the genetic polymorphism of NAT2 and CYP2E1 genes in tuberculosis patients who developed drug induced hepatitis upon administration of antituberculosis drugPolymorphism study of NAT2 and CYP2E1 gene may help in predicting the high risk group of ATT induced hepatitis
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