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:

MedlinePlus related topics: Hepatitis Tuberculosis

Drug Information available for: Isoniazid Rifamate Ftivazide

U.S. FDA Resources

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