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Isoniazid Dosage Prediction Model Development

Not Applicable
Conditions
NAT2 Genotype
Interventions
Genetic: genotype
Registration Number
NCT02747654
Lead Sponsor
Samsung Medical Center
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.

Detailed Description

Not available

Recruitment & Eligibility

Status
UNKNOWN
Sex
All
Target Recruitment
200
Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Genotype-guided dosinggenotypeINH dose determined based on developed model
Primary Outcome Measures
NameTimeMethod
Serum concentrations of INH1 month
Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

Samsung Medical Center

🇰🇷

Seoul, Korea, Republic of

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