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NAT2 in Re-challenge of INH in Patients With Hepatitis

This study is currently recruiting participants.
Verified November 2012 by National Taiwan University Hospital
Sponsor:
Collaborator:
Department of Health, Executive Yuan, R.O.C. (Taiwan)
Information provided by (Responsible Party):
National Taiwan University Hospital
ClinicalTrials.gov Identifier:
NCT00728546
First received: August 1, 2008
Last updated: December 26, 2012
Last verified: November 2012
History of Changes
  Purpose

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
Tuberculosis
Hepatotoxicity
 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:

Drug Information available for: Isoniazid
U.S. FDA Resources

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00728546

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

Locations
Taiwan
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)
Investigators
Principal Investigator: Li-Jiuan Shen, Ph.D. National Taiwan University
  More Information

No publications provided

Responsible Party: National Taiwan University Hospital
ClinicalTrials.gov 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:
tuberculosis
isoniazid
Arylamine N-acetyl transferase
 genotyping
hepatotoxicity
pharmacogenetics

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Tuberculosis
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Mycobacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
 Bacterial Infections
Isoniazid
Fatty Acid Synthesis Inhibitors
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antitubercular Agents
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Lipid Regulating Agents

ClinicalTrials.gov processed this record on June 18, 2013