Hepatotoxicity of Antituberculosis Therapy in a Real-World Setting: an Observational Study in China
试验速览
- 阶段
- 不适用
- 入组人数
- 5,000
- 主要终点
- Proportion of DILI in antituberculosis therapy
研究概览
简要总结
Drug-induced liver injury (DILI) is a common side effect in antituberculosis therapy, which interuputs the treatment of TB and leads to a higher proportion of Multidrug-Resistence TB(MDR-TB).The study primalily aims to observe the proportion of DILI in antituberculosis therapy. Furthermore, the secondary objective is to study the proportion of liver injury of based liver disase,liver failure and adjustment of chemotherapy in the obersevational study.
详细描述
Drug-induced liver injury (DILI) is a common side effect in antituberculosis therapy, which interuputs the treatment of TB and leads to a higher proportion of Multidrug-Resistence TB(MDR-TB).The study primalily aims to observe the proportion of DILI in antituberculosis therapy. Furthermore, the secondary objective is to study the proportion of liver injury of based liver disase,liver failure and adjustment of chemotherapy in the obersevational study.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who are about to start anti-tuberculosis treatment 2) Male or female, age > 18 years old 3) Voluntary signing of "Subject Informed Consent Form"
排除标准
- •A history of taking anti-tuberculosis drugs within 6 months before the treatment; 2)Abnormal liver function before starting anti-tuberculosis treatment; 3)DILI at the time of enrollment. 4)Combined with malignant tumors (including hematological tumors), HIV infection, etc.
- •According to the investigator's judgment, patients who cannot complete this study or who cannot comply with the requirements of this study.
结局指标
主要结局
Proportion of DILI in antituberculosis therapy
时间窗: 12 months(DILI occurs) or 24 months(None-DILI occur) after treatment initiation
The study primalily aims to observe the proportion of DILI in antituberculosis therapy,by monitoring and following up the liver function of the participants.
次要结局
- Proportion of liver injury of based liver disase,liver failure and adjustment of chemotherapy(12 months(DILI occurs) or 24 months(None-DILI occur) after treatment initiation)
研究者
Wen-hong Zhang
Director of Division of Infectious Diseases
Huashan Hospital