NCT03470233已完成不适用
Post-marketing Registry to Assess Usage Information, Safety and Effectiveness of Deltyba® Tablets in Korean Patients With Pulmonary Multi-drug Resistant Tuberculosis (MDR-TB)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 149
- 试验地点
- 2
- 主要终点
- Dose of Deltyba
研究概览
简要总结
Deltyba Registry aims to collect the usage information of Deltyba which could be a factor of developing resistance in actual clinical settings.
详细描述
To collect the usage information of Deltyba in actual clinical settings for the management of resistance to Deltyba
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Other
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Dose of Deltyba
时间窗: for 24 weeks
Mean values
Administration duration of Deltyba
时间窗: for 24 weeks
Mean values
Compliance of Deltyba
时间窗: for 24 weeks
percentages (%) of subjects who take Deltyba in excess of 80% compared with the amount of Deltyba prescribed by investigators
次要结局
- Response rate(at 24 week (at the end of Deltyba administration))
- Incidences of ADRs(at least 1 month after the final administration or premature discontinuation)
- Incidences of AEs(at least 1 month after the final administration or premature discontinuation)
- Incidences of AEs in special populations(at least 1 month after the final administration or premature discontinuation)
- Incidences of ADRs in special populations(at least 1 month after the final administration or premature discontinuation)
- Observed cases of resistance to Deltyba after completing the administration (Week 24) or premature discontinuation of Deltyba, Observed cases of resistance to Deltyba after 6 months of administration or discontinuation of administration(after completing the administration (Week 24) or premature discontinuation of Deltyba)
研究者
研究点 (2)
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