NAT 2 genotype guided INH dosage for tuberculosis treatment to reduce drug induced liver injury (DILI) in slow acetylator patients

NAT 2 genotype-guided INH dosage for tuberculosis treatment to reduce antituberculosis drug-induced liver injury in Thai patients

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

TCTR

Registry ID

TCTR20210801005

Enrollment

Registered

2021-08-01

Start date

2018-02-09

Completion date

Unknown

Last updated

2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

This study aimed to evaluated the adjusted dose INH can reduce incidence of AT-DILI in SA patients in Thai populations NAT 2 gene, Isoniazid, Tuberculosis, AT-DILI, Randomized control trial

Interventions

In adjusted dose INH group, we calculated dosage of INH based on Jin Ah Jung et al. study which found the serum concentrations of INH were affected by NAT2 genotype and body weight ,To achieve a ther

Experimental Drug,Active Comparator Drug

Adjusted dose INH, Standard dose INH

Eligibility

Sex/Gender

All

Age

18 Years to 90 Years

Inclusion criteria

Inclusion criteria: 1. Age more than 18 years 2. Newly diagnosed pulmonary tuberculosis 3. Slow acetylator phenotype 4. Provided written informed consent

Exclusion criteria

Exclusion criteria: 1) liver cirrhosis child pugh C; 2) alcoholism or alcohol drinking 14 days before enrollment abnormal liver function test at baseline; alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >3 times the upper limit of normal (ULN); 3) herbal medicine used; 4)HIV infection; 5) Chronic kidney disease define as eGFR < 30; 6) severe tuberculosis with high risk of poor outcome e.g., acute respiratory failure; 7) any conditions that may contribute unfavorable outcome; 8) life-threatening condition such as sepsis, respiratory failure, congestive heart failure; 9) body weight < 35 Kg and > 80 Kg; 10) pregnant and lactating woman.

Design outcomes

Primary

Measure	Time frame
drug-induced liver injury (DILI) 2,4,8 weeks Blood ALT or AST level more than 3 times ULN with hepatitis symptoms or more than 5 times ULN in the absence of symptoms.	—

Secondary

Measure	Time frame
The proportion of sputum smear conversion 2,4,8 weeks Sputum AFB smear,The proportion of sputum culture conversion 8 weeks Sputum culture for TB,clinical symptoms score 2,4,8 weeks symptoms profile score questinair,Adverse drug reactions 2,4,8 weeks medical history and physical examination	—

Countries

Thailand

Contacts

Public ContactThanyanuch Sanchat

Central Chest Institute of Thailand

sthanyanuch@gmail.com6625470999

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 9, 2026