NCT00834353

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
Completed

Started Sep 2005

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2005

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2008

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2008

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

February 2, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 3, 2009

Completed
Last Updated

February 3, 2009

Status Verified

February 1, 2009

Enrollment Period

2.5 years

First QC Date

February 2, 2009

Last Update Submit

February 2, 2009

Conditions

Pulmonary Tuberculosis

Study Arms (1)

Pulmonary tuberculosis patients

Freshly diagnosed pulmonary tuberculosis patients who are started with antituberculosis drugs

Drug: ATT

Interventions

ATTDRUG
Pulmonary tuberculosis patients

Eligibility Criteria

Age10 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Cases are enrolled in the study from primary care clinic after they are diagnosed with pulmonary tuberculosis.

You may qualify if:

  • Patients with pulmonary tuberculosis
  • Patients receiving conventional antituberculosis drugs
  • Patients who directly presented with antituberculosis drug induced hepatitis

You may not qualify if:

  • Habitual alcohol drinkers
  • Patients with evidence of viral hepatitis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Premashis Kar

New Delhi, New Delhi, 110002, India

Location

MeSH Terms

Conditions

Tuberculosis, Pulmonary

Condition Hierarchy (Ancestors)

TuberculosisMycobacterium InfectionsActinomycetales InfectionsGram-Positive Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfectionsRespiratory Tract InfectionsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Premashis Kar, MD,DM

    Maulana Azad Medical College, Department of Medicine.

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 2, 2009

First Posted

February 3, 2009

Study Start

September 1, 2005

Primary Completion

March 1, 2008

Study Completion

September 1, 2008

Last Updated

February 3, 2009

Record last verified: 2009-02

Locations

IN(1)