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

Tracking Information

First Received Date ^ICMJE

August 1, 2008

Last Updated Date

August 5, 2008

Start Date ^ICMJE

June 2008

Estimated Primary Completion Date

May 2010 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Decrease the envents of hepatotoxicity when patients are re-challenged with INH [ Time Frame: 6-12 months ] [ Designated as safety issue: Yes ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00728546 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

economics evaulation of performing phamacogenetics screening in practice [ Time Frame: 6-12 months ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief Summary

Apply the information of NAT2 genotyping into the re-challenge protocol of INH titration in patients with anti-TB medication induced hepatitis.

Detailed Description

Study Phase

Phase IV

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Open Label, Uncontrolled, Single Group Assignment, Safety Study

Condition ^ICMJE

Tuberculosis
Hepatotoxicity

Intervention ^ICMJE

Drug: Isoniazid (Rifinah)

Study Arms / Comparison Groups

Experimental: The dose of the re-challenged INH is followed by the resutls of the genotyping of NAT2 in each patient.

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

100

Estimated Completion Date

May 2010

Estimated Primary Completion Date

May 2010 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Li-Jiuan Shen, Ph.D.

33933670

ljshen@ntu.edu.tw

Location Countries ^ICMJE

Taiwan

Administrative Information

NCT ID ^ICMJE

NCT00728546

Responsible Party

Li-Jiuan Shen/ Assistant Professor, National Taiwan University

Study ID Numbers ^ICMJE

20080515M

Study Sponsor ^ICMJE

National Taiwan University Hospital

Collaborators ^ICMJE

Department of Health, Taiwan

Investigators ^ICMJE

Principal Investigator:

Li-Jiuan Shen, Ph.D.

National Taiwan University

Information Provided By

National Taiwan University Hospital

Verification Date

August 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP