NAT2 in Re-challenge of INH in Patients With Hepatitis

National Taiwan University Hospital100 enrolled

Overview

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

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

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

100

Conditions

Tuberculosis Hepatotoxicity

Interventions

Isoniazid (Rifinah)DRUG

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

National Taiwan University Hospital

Taipei, Taiwan

RECRUITING

Outcomes

Primary Outcomes

Decrease the events of hepatotoxicity when patients are re-challenged with INH

Time frame: 6-12 months

Secondary Outcomes

economics evaluation of performing pharmacogenetics screening in practice

Time frame: 6-12 months

Central Contacts

Li-Jiuan Shen, Ph.D.

CONTACT

33933670 ljshen@ntu.edu.tw

Data from ClinicalTrials.gov

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