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

National Taiwan University

Status: Unknown

Conditions: Hepatotoxicity

Treatments: Drug: isoniazid

Study type: Interventional

Funder types: Other

Identifiers

NCT02076685

200805015M

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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60 participants in 1 patient group

isoniazid rechalleng

Experimental group

Description:

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

Treatment:

Drug: isoniazid