Clinical Trial to Investigate the Appropriate Dose of Isoniazid According to NAT2 Polymorphism Status in Korean Subjects

Seoul National University Hospital1 site in 1 country16 target enrollmentMay 13, 2018

ConditionsTuberculosis Drug-Induced Liver Injury Adverse Drug Event

InterventionsIsoniazid

DrugsIsoniazid

Overview

Phase: Not Applicable
Intervention: Isoniazid
Conditions: Tuberculosis
Sponsor: Seoul National University Hospital
Enrollment: 16
Locations: 1
Primary Endpoint: Liver toxicity
Status: Completed
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

A clinical trial to investigate the appropriate dose of isoniazid according to NAT2 polymorphism status in Korean subjects

Registry

clinicaltrials.gov

Start Date

May 13, 2018

End Date

March 31, 2019

Last Updated

6 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Seoul National University Hospital

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Agreement with written informed consent
•Adult healthy male or female subject age 20 to 45

Exclusion Criteria

•Clinically significant, active gastrointestinal system, cardiovascular system, pulmonary system, renal system, endocrine system, blood system, digestive system, central nervous system, mental disease or malignancy
•Medication with any drug which may affect the pharmacokinetics of isoniazid within 14 days
•Previously donate whole blood within 30 days or Previously participated in other trial within 60 days
•Subject with known for hypersensitivity reactions to isoniazid
•Subject who can not perform contraception during study periods
•Female woman who are pregnant or are breast feeding
•An impossible one who participates in clinical trial by investigator's decision including laboratory test result

Arms & Interventions

Rapid metabolizer (Standard treatment)

Standard isoniazid dose regimen (300 mg qd)

Intervention: Isoniazid

Slow metabolizer (Standard treatment)

Standard isoniazid dose regimen (300 mg qd)

Intervention: Isoniazid

Slow metabolizer (PGx treatment)

Decreased isoniazid dose regimen (200 mg qd)

Intervention: Isoniazid

Outcomes

Primary Outcomes

Liver toxicity

Time Frame: up to 4 weeks

Number of participants with drug-induced liver injury as assessed by below criteria. * AST or ALT \> 5 ULN * AST or ALT \> 3 ULN and total bilirubin \> 2 ULN (Hy's law case) * ALT ratio/ALP ratio \> 5