NAT2 Genotyping in Re-challenge Protocol of INH Titration in Patients With Anti-TB Medications-induced Hepatitis

Hepatotoxicity 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: NCT02076685
• Other study ID #: 200805015M
• Status: Recruiting
• Phase: N/A
• First received: November 16, 2012
• Last updated: March 13, 2014
• Start date: November 2007
• Est. completion date: November 2015

Study information

• Verified date: March 2014
• Source: National Taiwan University Hospital
• Contact: Li-Jiuan Shen, Ph.D.
• Email: ljshen[@]ntu.edu.tw
• Is FDA regulated: No
• Health authority: Taiwan: Department of Health
• Study type: Interventional

Clinical Trial Summary

To improve the treatment outcome in patients with tuberculosis and integrate the pharmacogenetics into clinical practice, the information of NAT2 genotyping was used in re-challenge protocol for isoniazid (INH) titration in patients with anti-tuberculosis medication-induced hepatitis.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• 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:

1. >= 18 years.

2. Take INH for at least a week.

3. abnormal liver function (ALT (alanine, transaminase) increased by more than three times the upper limit of normal, or ALT higher than twice the upper limit of normal and total bilirubin higher than 2.0 mg / dL

Exclusion Criteria:

1.Taking INH before liver function abnormalities. 2.

Study Design

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

Related Conditions & MeSH terms

• Hepatotoxicity

Intervention

Drug:
• isoniazid
dose adjustment according to the pharmacogenomic results

Locations

Country	Name	City	State
Taiwan	National Taiwan University Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	successful re-use of isoniazid for TB treatment	In this study, we would like to test the hypothesis of NAT2 genotyping helping in isoniazid rechallenge after patients experienced adverse effects of anti-TB treatment. Therefore, to observe the patients can re-use isoniazid successfully is an important outcome measure in this study.	6 months	Yes