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

Sponsor

National Taiwan University Hospital (Other)

Overall Status

Unknown status

CT.gov ID

NCT02076685

Collaborator

(none)

Enrollment

Location

Arm

Duration (Months)

0.6

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Hepatotoxicity	Drug: isoniazid	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Supportive Care

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

Study Start Date :

Nov 1, 2007

Anticipated Primary Completion Date :

Nov 1, 2015

Anticipated Study Completion Date :

Nov 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: isoniazid rechalleng When patients encountered hepatotoxicity during the anti-TB treatment, genotyping and pk study of INH would be performed and dose adjustment accordingly.	Drug: isoniazid dose adjustment according to the pharmacogenomic results Other Names: Duracin, Rifina

Arm

Intervention/Treatment

Experimental: isoniazid rechalleng

When patients encountered hepatotoxicity during the anti-TB treatment, genotyping and pk study of INH would be performed and dose adjustment accordingly.

Drug: isoniazid

dose adjustment according to the pharmacogenomic results

Other Names:

Duracin, Rifina

Outcome Measures

Primary Outcome Measures

successful re-use of isoniazid for TB treatment [6 months]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

= 18 years.
Take INH for at least a week.
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