NAT2 in Re-challenge of INH in Patients With Hepatitis

Tuberculosis Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00728546
• Other study ID #: 20080515M
• Status: Recruiting
• Phase: Phase 4
• First received: August 1, 2008
• Last updated: December 26, 2012
• Start date: June 2008
• Est. completion date: November 2015

Study information

• Verified date: November 2012
• Source: National Taiwan University Hospital
• Contact: Li-Jiuan Shen, Ph.D.
• Phone: 33933670
• Email: ljshen[@]ntu.edu.tw
• Is FDA regulated: No
• Health authority: Taiwan: Department of Health
• Study type: Interventional

Clinical Trial Summary

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

Description:

adjusting INH dose according to NAT2 genotyping and serum concentration of INH.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: November 2015
• Est. primary completion date: November 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hepatotoxicity
• Tuberculosis

Intervention

Drug:
• Isoniazid (Rifinah)
The dose of the re-challenged INH is followed by the results of the genotyping of NAT2 in each patient.

Locations

Country	Name	City	State
Taiwan	National Taiwan University Hospital	Taipei

Sponsors (2)

Lead Sponsor	Collaborator
National Taiwan University Hospital	Department of Health, Executive Yuan, R.O.C. (Taiwan)

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Decrease the events of hepatotoxicity when patients are re-challenged with INH		6-12 months	Yes
Secondary	economics evaluation of performing pharmacogenetics screening in practice		6-12 months	No