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:
Information provided by:
Maulana Azad Medical College
ClinicalTrials.gov Identifier:
NCT00834353
First received: February 2, 2009
Last updated: NA
Last verified: February 2009
History: No changes posted
  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

Ages Eligible for Study:   10 Years to 70 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: February 2, 2009
Last Updated: February 2, 2009
Health Authority: India: Indian Council of Medical Research

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Tuberculosis
Tuberculosis, Pulmonary
Drug-Induced Liver Injury
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Mycobacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Poisoning
Substance-Related Disorders
Antitubercular Agents
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 23, 2014