N-Acetyltransferase 2 (NAT2) Genotyping in re-Challenge of Isoniazid (INH) in Patients With Antituberculous (Anti-TB) Medications-Induced Hepatitis

The recruitment status of this study is unknown because the information has not been verified recently.

Verified August 2008 by National Taiwan University Hospital. Recruitment status was Recruiting

First Received on August 1, 2008. Last Updated on 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:	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:

MedlinePlus related topics: Hepatitis Hepatitis A 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
Experimental: 1 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. Other Names: Isoniazid Rifinah

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:	Li-Jiuan Shen/ Assistant Professor, National Taiwan University
ClinicalTrials.gov Identifier:	NCT00728546 History of Changes
Other Study ID Numbers:	20080515M
Study First Received:	August 1, 2008
Last Updated:	August 5, 2008
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 February 12, 2012