NAT2 in Re-challenge of INH in Patients With Hepatitis

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2012 by National Taiwan University Hospital.
Recruitment status was  Recruiting
Department of Health, Executive Yuan, R.O.C. (Taiwan)
Information provided by (Responsible Party):
National Taiwan University Hospital Identifier:
First received: August 1, 2008
Last updated: December 26, 2012
Last verified: November 2012
Apply the information of NAT2 genotyping into the re-challenge protocol of INH titration in patients with anti-TB medication induced hepatitis.

Condition Intervention Phase
Drug: Isoniazid (Rifinah)
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:

Further study details as provided by National Taiwan University Hospital:

Primary Outcome Measures:
  • Decrease the events of hepatotoxicity when patients are re-challenged with INH [ Time Frame: 6-12 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • economics evaluation of performing pharmacogenetics screening in practice [ Time Frame: 6-12 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: June 2008
Estimated Study Completion Date: November 2015
Estimated Primary Completion Date: November 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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Please refer to this study by its identifier: NCT00728546

Contact: Li-Jiuan Shen, Ph.D. 33933670

National Taiwan University Hospital Recruiting
Taipei, Taiwan, 100
Contact: Li-Jiuan Shen, Ph.D.    886-2-2312-3456 ext 8411   
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

No publications provided

Responsible Party: National Taiwan University Hospital Identifier: NCT00728546     History of Changes
Other Study ID Numbers: 20080515M 
Study First Received: August 1, 2008
Last Updated: December 26, 2012
Health Authority: Taiwan: Department of Health

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

Additional relevant MeSH terms:
Actinomycetales Infections
Bacterial Infections
Gram-Positive Bacterial Infections
Mycobacterium Infections
Anti-Bacterial Agents
Anti-Infective Agents
Antitubercular Agents
Fatty Acid Synthesis Inhibitors
Hypolipidemic Agents
Lipid Regulating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses processed this record on February 11, 2016