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
Group Intervention Description Genotype-guided dosing genotype INH dose determined based on developed model
- Primary Outcome Measures
Name Time Method Serum concentrations of INH 1 month
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Samsung Medical Center
🇰🇷Seoul, Korea, Republic of