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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| genotype | Genetic | 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, |
| Measure | Description | Time Frame |
|---|---|---|
| Serum concentrations of INH | 1 month |
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Soo-Youn . Lee, MD | Contact | 82-2-3410-1834 | sy117.lee@samsung.com |
| Name | Affiliation | Role |
|---|---|---|
| Soo-Youn Lee, MD | Sargodha Medical College | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Samsung Medical Center | Recruiting | Seoul | Seoul | 135-710 | South Korea |
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| ID | Term |
|---|---|
| D005838 | Genotype |
| ID | Term |
|---|---|
| D055614 | Genetic Phenomena |
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