Isoniazid Dosage Prediction Model Development

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Samsung Medical Center

Status

Unknown

Conditions

NAT2 Genotype

Treatments

Genetic: genotype

Study type

Interventional

Funder types

Other

Identifiers

NCT02747654
SMC-2013-07-155-002

Details and patient eligibility

About

Isoniazid (INH) is an essential component of first-line anti-tuberculosis (TB) treatment. However, treatment with INH is complicated by polymorphisms in the expression of the enzyme system primarily responsible for its elimination, N-acetyltransferase 2 (NAT2), and its associated hepatotoxicity. The objective of this study was to develop an individualized INH dosing regimen using a pharmacogenetic-driven model and to apply this regimen in a pilot study.

Enrollment

200 estimated patients

Sex

All

Ages

17 to 80 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

  • Eligible participants were patients newly diagnosed with active TB
  • Who underwent standard four drug treatment for 6months: isoniazid (5 mg/kg, usually 300 mg), rifampin (450 mg for <50 kg or 600 mg for 50 kg body weight), ethambutol(15mg/kg), and pyrazinamide (20 - 30 mg/kg)
  • Given daily for two months and followed by isoniazid and rifampin with or without ethambutol for four months.
  • Those patients with abnormal hepatic function on laboratory testing (increased serum aspartate aminotransferase, alanine aminotransferase, or total bilirubin) before anti-TB treatment, underlying liver disease or systemic illness such as congestive heart failure, acute life-threatening disease, or alcoholism, or disease that was resistant to INH at the start of treatment were excluded.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

200 participants in 2 patient groups

standard dosing
No Intervention group
Description:
a standard treatment group; INH dose of 300 mg or 200 mg based on the body weight
Genotype-guided dosing
Experimental group
Description:
INH dose determined based on developed model
Treatment:
Genetic: genotype

Trial contacts and locations

1

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Central trial contact

Soo-Youn . Lee, MD

Data sourced from clinicaltrials.gov

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