NCT00728546Unknown4 期
The Application of the N-acetyltransferase 2 (NAT2) Genotyping in Re-challenge Protocol of Isoniazid (INH) Titration in Patients With Anti-TB Medications-induced Hepatitis
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Decrease the events of hepatotoxicity when patients are re-challenged with INH
研究概览
简要总结
Apply the information of NAT2 genotyping into the re-challenge protocol of INH titration in patients with anti-TB medication induced hepatitis.
详细描述
adjusting INH dose according to NAT2 genotyping and serum concentration of INH.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Older than 18 years-old
- •Taken INH for more than 1 week
- •Abnormal liver function
- •Exclusion criteria:
- •Rule out the INH induced liver abnormality
- •Existing reasons to cause liver abnormality other than TB-medication
- •Taking drugs which interact with INH
排除标准
- 未提供
研究组 & 干预措施
INA dose adjustment, NAT2
Experimental
The dose of the re-challenged INH is followed by the results of the genotyping of NAT2 in each patient.
干预措施: Isoniazid (Rifinah) (Drug)
结局指标
主要结局
Decrease the events of hepatotoxicity when patients are re-challenged with INH
时间窗: 6-12 months
次要结局
- economics evaluation of performing pharmacogenetics screening in practice(6-12 months)
研究者
研究点 (1)
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