NAT2 in Re-challenge of INH in Patients With Hepatitis

National Taiwan University

Status and phase: Unknown; Phase 4

Conditions: Tuberculosis; Hepatotoxicity

Treatments: Drug: Isoniazid (Rifinah)

Study type: Interventional

Funder types: Other

Identifiers

NCT00728546

20080515M

Details and patient eligibility

About

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

Full description

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

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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100 participants in 1 patient group

INA dose adjustment, NAT2

Experimental group

Description:

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

Treatment:

Drug: Isoniazid (Rifinah)