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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00834353
Recruitment Status : Completed
First Posted : February 3, 2009
Last Update Posted : February 3, 2009
Information provided by:
Maulana Azad Medical College

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

Condition or disease Intervention/treatment
Pulmonary Tuberculosis Drug: ATT

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Study Type : Observational
Observational Model: Case Control
Time Perspective: Prospective
Official Title: Prospective Study of N-acetyltransferase2 (NAT2) Gene and Rifampicin Induced Cytochrome P-450 as Susceptible Risk Factors for Antituberculosis Drug Induced Hepatitis
Study Start Date : September 2005
Actual Primary Completion Date : March 2008
Actual Study Completion Date : September 2008

Resource links provided by the National Library of Medicine

Group/Cohort Intervention/treatment
Pulmonary tuberculosis patients
Freshly diagnosed pulmonary tuberculosis patients who are started with antituberculosis drugs
Drug: ATT

Information from the National Library of Medicine

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Ages Eligible for Study:   10 Years to 70 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Cases are enrolled in the study from primary care clinic after they are diagnosed with pulmonary tuberculosis.

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00834353

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Premashis Kar
New Delhi, India, 110002
Sponsors and Collaborators
Maulana Azad Medical College
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Principal Investigator: Premashis Kar, MD,DM Maulana Azad Medical College, Department of Medicine.

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Responsible Party: Dr. Premashis kar, Director Professor, Deptt. Medicine, MAMC, New Delhi Identifier: NCT00834353     History of Changes
Other Study ID Numbers: F.501(134)/02-EC/MC(Aca)/16713
First Posted: February 3, 2009    Key Record Dates
Last Update Posted: February 3, 2009
Last Verified: February 2009

Additional relevant MeSH terms:
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Tuberculosis, Pulmonary
Mycobacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Antitubercular Agents
Anti-Bacterial Agents
Anti-Infective Agents