NCT02747654

Brief Summary

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.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2014

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

April 19, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 22, 2016

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
Last Updated

April 22, 2016

Status Verified

April 1, 2016

Enrollment Period

2.5 years

First QC Date

April 19, 2016

Last Update Submit

April 21, 2016

Conditions

NAT2 Genotype

Keywords

NAT2 genotype guided dosing

Outcome Measures

Primary Outcomes (1)

  • Serum concentrations of INH

    1 month

Study Arms (2)

standard dosing

NO INTERVENTION

a standard treatment group; INH dose of 300 mg or 200 mg based on the body weight

Genotype-guided dosing

EXPERIMENTAL

INH dose determined based on developed model

Genetic: genotype

Interventions

genotypeGENETIC

Patients were randomly assigned to a standard treatment group; INH dose of 300 mg or 200 mg based on the body weight) or model-based treatment group; INH dose determined based on developed model,

Genotype-guided dosing

Eligibility Criteria

Age17 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
* 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.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Samsung Medical Center

Seoul, Seoul, 135-710, South Korea

RECRUITING

MeSH Terms

Interventions

Genotype

Intervention Hierarchy (Ancestors)

Genetic Phenomena

Study Officials

  • Soo-Youn Lee, MD

    Sargodha Medical College

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Soo-Youn . Lee, MD

CONTACT

82-2-3410-1834sy117.lee@samsung.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 19, 2016

First Posted

April 22, 2016

Study Start

June 1, 2014

Primary Completion

December 1, 2016

Last Updated

April 22, 2016

Record last verified: 2016-04

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)