NAT2 in Re-challenge of INH in Patients With Hepatitis

This study is currently recruiting participants. (see Contacts and Locations)
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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
Tuberculosis
Mycobacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Isoniazid
Antitubercular Agents
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Fatty Acid Synthesis Inhibitors
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents

ClinicalTrials.gov processed this record on September 30, 2014