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NCT00834353 Clinical Trial

Prospective Study of N-acetyltransferase2 (NAT2) and Cytochrome P4502E1 (CYP2E1) Gene as Susceptible Risk Factors for Antituberculosis (ATT) Induced Hepatitis

Pulmonary Tuberculosis Clinical Trial

Official title:
Prospective Study of N-acetyltransferase2 (NAT2) Gene and Rifampicin Induced Cytochrome P-450 as Susceptible Risk Factors for Antituberculosis Drug Induced Hepatitis

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00834353
Other study ID # F.501(134)/02-EC/MC(Aca)/16713
Secondary ID
Status Completed
Phase N/A
First received February 2, 2009
Last updated February 2, 2009
Start date September 2005
Est. completion date September 2008

Study information
Verified date February 2009
Source Maulana Azad Medical College
Contact n/a
Is FDA regulated No
Health authority India: Indian Council of Medical Research
Study type Observational

Clinical Trial 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 drug.Polymorphism study of NAT2 and CYP2E1 gene may help in predicting the high risk group of ATT induced hepatitis.

Recruitment information / eligibility
Status Completed
Enrollment 0
Est. completion date September 2008
Est. primary completion date March 2008
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 10 Years to 70 Years
Eligibility Inclusion Criteria:

- Patients with pulmonary tuberculosis

- Patients receiving conventional antituberculosis drugs

- Patients who directly presented with antituberculosis drug induced hepatitis

Exclusion Criteria:

- Habitual alcohol drinkers

- Patients with evidence of viral hepatitis

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

Intervention

Drug:
• ATT

Locations
Country Name City State
India Premashis Kar New Delhi

Sponsors (1)
Lead Sponsor Collaborator
Maulana Azad Medical College

Country where clinical trial is conducted

India, 

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