A Prospective and Multicenter Cohort Study of Bicyclol in the Treatment of Antineoplastic Drug-induced Liver Injury.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 5,405
- 试验地点
- 1
- 主要终点
- The changes in ALT level from baseline after 4 weeks treatment of bicyclol
研究概览
简要总结
The clinical trial is designed to evaluate the efficacy of bicyclol for patients with antineoplastic drug-induced liver injury and investigate factors effecting the therapeutic outcome.
详细描述
This study prospectively studied the treatment of acute drug-induced liver injury related to anti-tumor with bicyclol tablets, to provide medical evidence in clinical practice of bicyclol treating acute drug-induced liver injury. The main purpose of this study is to evaluate the clinical efficacy and outcome of bicyclol tablets in the treatment of drug-induced liver injury and analyze the bicyclol tablet's therapeutic effects in different groups including conventional chemotherapy drugs, targeted drugs, and immunosuppressants. The secondary purpose of this study is to analyze the factors influencing the prognosis and outcome of bicyclol tablets in the treatment of acute DILI.
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
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The acute liver injury caused by anti-tumor drugs
- •The RUCAM assessment scale ≥6
- •The liver injury must in the acute phase
- •Must be treated with bicyclol tablets
- •Must sign informed consent -
排除标准
- •This acute liver injury caused by non-anti-tumor drugs
- •Pregnant women
- •Lactating women
- •Childbearing age women are plan to conceive
研究组 & 干预措施
Liver Injury Group
The patients have liver injuries caused by antitumor drugs.
干预措施: Bicyclol tablets (Drug)
结局指标
主要结局
The changes in ALT level from baseline after 4 weeks treatment of bicyclol
时间窗: 4 weeks
Excellence: clinical symptoms and signs disappeared, serum ALT returned to normal; Improvement: clinical symptoms disappeared (improved), serum ALT decreased more than 50% of the original value; Invalid: Failure to meet the above criteria
次要结局
- The changes of ALT levels compared with baseline(less than 4 weeks)
- The condition of acute liver injuries becomes the chronic liver disease(6 months)
- The changes of AST levels compared with baseline(less than 4 weeks)