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NAT2 in Re-challenge of INH in Patients With Hepatitis

Sponsor
National Taiwan University Hospital (Other)
Overall Status
Unknown status
CT.gov ID
NCT00728546
Collaborator
Department of Health, Executive Yuan, R.O.C. (Taiwan) (Other)
100
Enrollment
1
Location
1
Arm
89
Duration (Months)
1.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Apply the information of NAT2 genotyping into the re-challenge protocol of INH titration in patients with anti-TB medication induced hepatitis.

Condition or Disease Intervention/Treatment Phase
  • Drug: Isoniazid (Rifinah)
 Phase 4

Detailed Description

adjusting INH dose according to NAT2 genotyping and serum concentration of INH.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
100 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
The Application of the N-acetyltransferase 2 (NAT2) Genotyping in Re-challenge Protocol of Isoniazid (INH) Titration in Patients With Anti-TB Medications-induced Hepatitis
Study Start Date :
Jun 1, 2008
Anticipated Primary Completion Date :
Nov 1, 2015
Anticipated Study Completion Date :
Nov 1, 2015

Arms and Interventions

Arm Intervention/Treatment
Experimental: INA dose adjustment, NAT2

The dose of the re-challenged INH is followed by the results of the genotyping of NAT2 in each patient.

Drug: Isoniazid (Rifinah)
The dose of the re-challenged INH is followed by the results of the genotyping of NAT2 in each patient.
Other Names:
  • Isoniazid
  • Rifinah

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Decrease the events of hepatotoxicity when patients are re-challenged with INH [6-12 months]

    Secondary Outcome Measures

    1. economics evaluation of performing pharmacogenetics screening in practice [6-12 months]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Older than 18 years-old

    • Taken INH for more than 1 week

    • Abnormal liver function

    Exclusion criteria:

    • Rule out the INH induced liver abnormality

    • Existing reasons to cause liver abnormality other than TB-medication

    • Taking drugs which interact with INH

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 National Taiwan University Hospital Taipei Taiwan 100

    Sponsors and Collaborators

    • National Taiwan University Hospital
    • Department of Health, Executive Yuan, R.O.C. (Taiwan)

    Investigators

    • Principal Investigator: Li-Jiuan Shen, Ph.D., National Taiwan University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    National Taiwan University Hospital
    ClinicalTrials.gov Identifier:
    NCT00728546
    Other Study ID Numbers:
    • 20080515M
    First Posted:
    Aug 6, 2008
    Last Update Posted:
    Dec 27, 2012
    Last Verified:
    Nov 1, 2012
    Keywords provided by National Taiwan University Hospital
    tuberculosis
    isoniazid
    Arylamine N-acetyl transferase
    genotyping
    hepatotoxicity
    pharmacogenetics
    Additional relevant MeSH terms:
    Tuberculosis
    Isoniazid

    Study Results

    No Results Posted as of Dec 27, 2012