NCT01802996Unknown4 期
A Randomized, Controlled, Multi-center Collaborative Study to Evaluate the Efficacy of Magnesium Isoglycyrrhizinate Injection in the Prevention of Antineoplastic Chemotherapy Related Acute Liver Injury
Cttq27 个研究点 分布在 1 个国家目标入组 2,040 人开始时间: 2013年3月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 2,040
- 试验地点
- 27
- 主要终点
- The incidence of liver injury
研究概览
简要总结
This purpose of this study is to evaluate the evaluate the efficacy of Magnesium Isoglycyrrhizinate Injection in the prevention of antineoplastic chemotherapy related acute liver injury.
详细描述
Total subjects: 2040, experimental group of 1360 patients, control group of 680 patients. According to the study subjects receiving antineoplastic chemotherapy, subjects are stratified randomize.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female aged 18-75 years;
- •Patients with malignant tumor accord with chemotherapy indication, candidate to a chemotherapy treatment, disease is not restricted;
- •Accorded with the following chemotherapy plan: included cis-platinum, ≥60mg/m2/course; included oxaliplatin, ≥85mg/m2/course; included cyclophosphamide, ≥600mg/m2/course; included gemcitabine, ≥60mg/m2/course;
- •Estimates survival time≥3 months;
- •TBIL≤1.0×ULN, ALT、AST≤1.0×ULN; blood examination, uronoscopy, stool examination, renal function tests and electrocardiogram are normal;
- •Patients have been apart from the previous chemotherapy to finish above 2 weeks (including 2 weeks).
排除标准
- •Patients with partial liver radiotherapy;
- •Hepatitis B or C virus replication in the state, the patient will need antiviral therapy;
- •Patients have serious heart diseases, liver kidney diseases, or metabolism function disorder;
- •Patients combined with cellular immune therapy;
- •Within 2 weeks of application or currently possible applications of drugs(polyene phosphatidylcholine, reduced glutathione, tiopronin and other hepatoprotective and choleretic drugs), interference with the study;
- •Pregnancy, or patients during breast feeding;
- •Patients have known hypersensitivity to Glycyrrhizin;
- •Patients are participating, or have participated in other Clinical studies of new drugs within 4 weeks.
研究组 & 干预措施
Arm I
Experimental
Magnesium Isoglycyrrhizinate Injection 200mg IV on days 1-5
干预措施: Magnesium Isoglycyrrhizinate Injection (Drug)
结局指标
主要结局
The incidence of liver injury
时间窗: 0-15 days
anyone of ALT、AST、ALP、TBIL、DBIL、γ-GT\>ULN
次要结局
未报告次要终点
研究者
研究点 (27)
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