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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

Sponsors and Collaborators: National Taiwan University Hospital
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

MedlinePlus related topics:   Hepatitis    Tuberculosis   

Drug Information available for:   Isoniazid    Ftivazide    Rifamate   

U.S. FDA Resources

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

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


Responsible Party:   National Taiwan University ( Li-Jiuan Shen/ Assistant Professor )
Study ID Numbers:   20080515M
First Received:   August 1, 2008
Last Updated:   August 5, 2008
ClinicalTrials.gov Identifier:   NCT00728546
Health Authority:   Taiwan: Department of Health

Keywords provided by National Taiwan University Hospital:
tuberculosis  
isoniazid  
Arylamine N-acetyl transferase  
genotyping
hepatotoxicity
pharmacogenetics

Study placed in the following topic categories:
Bacterial Infections
Hepatitis
Gram-Positive Bacterial Infections
Liver Diseases
Digestive System Diseases
Mycobacterium Infections
Tuberculosis
Isoniazid

Additional relevant MeSH terms:
Antimetabolites
Anti-Infective Agents
Anti-Bacterial Agents
Molecular Mechanisms of Pharmacological Action
Therapeutic Uses
Antilipemic Agents
Antitubercular Agents
Pharmacologic Actions
Fatty Acid Synthesis Inhibitors
Actinomycetales Infections

ClinicalTrials.gov processed this record on December 03, 2008




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