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| Name | Class |
|---|---|
| Ministry of Health & Welfare, Korea | OTHER_GOV |
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A clinical trial to investigate the appropriate dose of isoniazid according to NAT2 polymorphism status in Korean subjects
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Rapid metabolizer (Standard treatment) | Active Comparator | Standard isoniazid dose regimen (300 mg qd) |
|
| Slow metabolizer (Standard treatment) | Active Comparator | Standard isoniazid dose regimen (300 mg qd) |
|
| Slow metabolizer (PGx treatment) | Experimental | Decreased isoniazid dose regimen (200 mg qd) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Isoniazid | Drug | One of the first line anti-tubercolosis drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Liver toxicity | Number of participants with drug-induced liver injury as assessed by below criteria.
| up to 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Drug exposure | Plasma isoniazid concentration | Day 1 and day 29 0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 24 post-dose |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Hospital Clinical Trials Center | Seoul | 110-744 | South Korea |
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| ID | Term |
|---|---|
| D014376 | Tuberculosis |
| D056486 | Chemical and Drug Induced Liver Injury |
| D064420 | Drug-Related Side Effects and Adverse Reactions |
| ID | Term |
|---|---|
| D009164 | Mycobacterium Infections |
| D000193 | Actinomycetales Infections |
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
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| ID | Term |
|---|---|
| D007538 | Isoniazid |
| ID | Term |
|---|---|
| D006834 | Hydrazines |
| D009930 | Organic Chemicals |
| D007539 | Isonicotinic Acids |
| D000147 | Acids, Heterocyclic |
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| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D064419 | Chemically-Induced Disorders |
| D011041 | Poisoning |
| D006571 |
| Heterocyclic Compounds |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |