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NAT2 in Re-challenge of INH in Patients With 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.
ClinicalTrials.gov Identifier: NCT00728546
Recruitment Status : Unknown
Verified November 2012 by National Taiwan University Hospital.
Recruitment status was:  Recruiting
First Posted : August 6, 2008
Last Update Posted : December 27, 2012
Information provided by (Responsible Party):

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
Tuberculosis Hepatotoxicity Drug: Isoniazid (Rifinah) Phase 4

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

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
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 : June 2008
Estimated Primary Completion Date : November 2015
Estimated Study Completion Date : November 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hepatitis
Drug Information available for: Isoniazid
U.S. FDA Resources

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 [ Time Frame: 6-12 months ]

Secondary Outcome Measures :
  1. economics evaluation of performing pharmacogenetics screening in practice [ Time Frame: 6-12 months ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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

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): NCT00728546

Contact: Li-Jiuan Shen, Ph.D. 33933670 ljshen@ntu.edu.tw

National Taiwan University Hospital Recruiting
Taipei, Taiwan, 100
Contact: Li-Jiuan Shen, Ph.D.    886-2-2312-3456 ext 8411    ljshen@ntu.edu.tw   
Principal Investigator: Li-Jiuan Shen, Ph.D.         
Sponsors and Collaborators
National Taiwan University Hospital
Department of Health, Executive Yuan, R.O.C. (Taiwan)
Principal Investigator: Li-Jiuan Shen, Ph.D. National Taiwan University
More Information

Responsible Party: National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT00728546     History of Changes
Other Study ID Numbers: 20080515M
First Posted: August 6, 2008    Key Record Dates
Last Update Posted: December 27, 2012
Last Verified: November 2012

Keywords provided by National Taiwan University Hospital:
Arylamine N-acetyl transferase

Additional relevant MeSH terms:
Mycobacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Antitubercular Agents
Anti-Bacterial Agents
Anti-Infective Agents
Fatty Acid Synthesis Inhibitors
Hypolipidemic Agents
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents