NCT06670391进行中（未招募）不适用
A Retrospective, Real-world, Electronic Medical Record-based Study on Patients With Liver Injury After the Administration of Novel Antineoplastic Agents
Drug Induced Liver Disease Study Group1 个研究点 分布在 1 个国家目标入组 2,000 人开始时间: 2023年5月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 2,000
- 试验地点
- 1
- 主要终点
- Change in ALT (alanine aminotransferase)
研究概览
简要总结
This is an open-enrollment, retrospective, observational study without interventions. Its primary objective is to understand 1) incidence of liver injury among all the hospitalized patient from participating centers after the administration of immune checkpoint inhibitors or molecularly targeted agents; 2) epidemiologic and clinical characteristics of liver injury, including suspected medications, clinical types, histological characteristics, severity, treatment and outcomes.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Retrospective
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
- •Age ≥ 18 years
- •Abnormality of liver biochemistry after the administration of any molecularly targeted agent or immune checkpoint inhibitor
排除标准
- •Missing major baseline or clinical data
- •Prior liver loco-regional therapy or surgery
结局指标
主要结局
Change in ALT (alanine aminotransferase)
时间窗: on day 10
Absolute change
次要结局
- Proportion of patients with normalized liver biochemistry(on day 3, 7, 10, 14, 21, and 30)
- Change in liver biochemistry(on day 3, 7, 10, 14, 21, and 30)
- Time to normalization of liver biochemistry(up to 6 month)
- Proportion of patients with ≥ 50% reduction in liver biochemistry(on day 3, 7, 10, 14, 21, and 30)
研究者
Yimin Mao
Chairman
Drug Induced Liver Disease Study Group
研究点 (1)
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