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N-Acetyltransferase 2 (NAT2) Genotyping in re-Challenge of Isoniazid (INH) in Patients With Antituberculous (Anti-TB) Medications-Induced Hepatitis
This study is currently recruiting participants.
Verified by National Taiwan University Hospital, August 2008
First Received: August 1, 2008   Last Updated: August 5, 2008   History of Changes
Sponsor: National Taiwan University Hospital
Collaborator: Department of Health, Taiwan
Information provided by: National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT00728546
  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 IV

Study Type: Interventional
Study Design: Treatment, Open Label, Uncontrolled, Single Group Assignment, Safety Study
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 envents of hepatotoxicity when patients are re-challenged with INH [ Time Frame: 6-12 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • economics evaulation of performing phamacogenetics 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: May 2010
Estimated Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Experimental
The dose of the re-challenged INH is followed by the resutls of the genotyping of NAT2 in each patient.
Drug: Isoniazid (Rifinah)
The dose of the re-challenged INH is followed by the resutls of the genotyping of NAT2 in each patient.

  Eligibility

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

Inclusion Criteria:

  • older than 18 year-old
  • Taken INH for more than 1 week
  • Abnormal liver function

Exclusion criteria:

  • Rule out the INH induced liver abnormality
  • Exisiting reasons cause liver abnormality other than TB-medication
  • Taken 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, Taiwan
Investigators
Principal Investigator: Li-Jiuan Shen, Ph.D. National Taiwan University
  More Information

No publications provided

Responsible Party: National Taiwan University ( Li-Jiuan Shen/ Assistant Professor )
Study ID Numbers: 20080515M
Study First Received: August 1, 2008
Last Updated: August 5, 2008
ClinicalTrials.gov Identifier: NCT00728546     History of Changes
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:
Bacterial Infections
Antimetabolites
Anti-Infective Agents
Liver Diseases
Molecular Mechanisms of Pharmacological Action
Antilipemic Agents
Pharmacologic Actions
Actinomycetales Infections
Hepatitis
Anti-Bacterial Agents
Gram-Positive Bacterial Infections
Digestive System Diseases
Therapeutic Uses
Mycobacterium Infections
Tuberculosis
Antitubercular Agents
Fatty Acid Synthesis Inhibitors
Isoniazid

ClinicalTrials.gov processed this record on November 27, 2009