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

N/AUnknownNCT02076685

National Taiwan University Hospital60 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

Conditions

Hepatotoxicity

Interventions

isoniazidDRUG

dose adjustment according to the pharmacogenomic results

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

National Taiwan University Hospital

Taipei, Taiwan

RECRUITING

Outcomes

Primary Outcomes

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.

Time frame: 6 months

Central Contacts

Li-Jiuan Shen, Ph.D.

CONTACT

ljshen@ntu.edu.tw

Data from ClinicalTrials.gov

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