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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00834353
First Posted: February 3, 2009
Last Update Posted: February 3, 2009
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.
Information provided by:
Maulana Azad Medical College
  Purpose
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 Intervention
Pulmonary Tuberculosis Drug: ATT

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Maulana Azad Medical College:

Study Start Date: September 2005
Study Completion Date: September 2008
Primary Completion Date: March 2008 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Pulmonary tuberculosis patients
Freshly diagnosed pulmonary tuberculosis patients who are started with antituberculosis drugs
Drug: ATT

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   10 Years to 70 Years   (Child, Adult, Senior)
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.
Criteria

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
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT00834353


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

Responsible Party: Dr. Premashis kar, Director Professor, Deptt. Medicine, MAMC, New Delhi
ClinicalTrials.gov Identifier: NCT00834353     History of Changes
Other Study ID Numbers: F.501(134)/02-EC/MC(Aca)/16713
First Submitted: February 2, 2009
First Posted: February 3, 2009
Last Update Posted: February 3, 2009
Last Verified: February 2009

Additional relevant MeSH terms:
Tuberculosis
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