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NAT2 in Re-challenge of INH in Patients With Hepatitis

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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
Sponsor:
Collaborator:
Information provided by (Responsible Party):

August 1, 2008
August 6, 2008
December 27, 2012
June 2008
November 2015   (Final data collection date for primary outcome measure)
Decrease the events of hepatotoxicity when patients are re-challenged with INH [ Time Frame: 6-12 months ]
Decrease the envents of hepatotoxicity when patients are re-challenged with INH [ Time Frame: 6-12 months ]
Complete list of historical versions of study NCT00728546 on ClinicalTrials.gov Archive Site
economics evaluation of performing pharmacogenetics screening in practice [ Time Frame: 6-12 months ]
economics evaulation of performing phamacogenetics screening in practice [ Time Frame: 6-12 months ]
Not Provided
Not Provided
 
NAT2 in Re-challenge of INH in Patients With Hepatitis
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
Apply the information of NAT2 genotyping into the re-challenge protocol of INH titration in patients with anti-TB medication induced hepatitis.
adjusting INH dose according to NAT2 genotyping and serum concentration of INH.
Interventional
Phase 4
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Tuberculosis
  • Hepatotoxicity
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
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.
Intervention: Drug: Isoniazid (Rifinah)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
100
November 2015
November 2015   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Taiwan
 
 
NCT00728546
20080515M
Yes
Not Provided
Not Provided
National Taiwan University Hospital
National Taiwan University Hospital
Department of Health, Executive Yuan, R.O.C. (Taiwan)
Principal Investigator: Li-Jiuan Shen, Ph.D. National Taiwan University
National Taiwan University Hospital
November 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP