NCT02747654Unknown不适用
Development of a Dosing Model Based on Anti-tuberculosis Drug Monitoring NAT2 Genotypes in Tuberculosis Patients.
适应症
干预措施
试验速览
- 阶段
- 不适用
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Serum concentrations of INH
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 17 Years 至 80 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- 未提供
研究组 & 干预措施
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
干预措施: genotype (Genetic)
结局指标
主要结局
Serum concentrations of INH
时间窗: 1 month
次要结局
未报告次要终点
研究者
研究点 (1)
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