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

NCT ID: NCT00834353

Last Updated: 2009-02-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Study Classification

OBSERVATIONAL

Study Start Date

2005-09-30

Study Completion Date

2008-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Pulmonary Tuberculosis

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Pulmonary tuberculosis patients

Freshly diagnosed pulmonary tuberculosis patients who are started with antituberculosis drugs

ATT

Intervention Type DRUG

Interventions

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ATT

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

10 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Maulana Azad Medical College

OTHER

Sponsor Role lead

Responsible Party

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Director Professor, Deptt. Medicine, MAMC, New Delhi

Principal Investigators

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Premashis Kar, MD,DM

Role: PRINCIPAL_INVESTIGATOR

Maulana Azad Medical College, Department of Medicine.

Locations

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Premashis Kar

New Delhi, New Delhi, India

Site Status

Countries

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India

Other Identifiers

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F.501(134)/02-EC/MC(Aca)/16713

Identifier Type: -

Identifier Source: org_study_id

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