NCT04553003招募中4 期
Glucocorticosteroid Therapy on Drug-induced Liver Injury: a Prospective Non-randomized Concurrent Control Trial
Li Yang1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2020年8月1日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- percentage of patients that AST or ALT decline 25% at day 4
研究概览
简要总结
The purpose of this study is to assess the safety and efficacy of glucocorticosteroid for treatment of drug-induced liver injury.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of DILI
- •RUCAM score≥6 and with liver histology
- •Meet any of the following conditions:
- •TBIL ≥ 10 fold ULN ;
- •TBIL ≥ 5 fold ULN and serum AST or ALT ≥ 20 fold ULN
排除标准
- •An chronic onset (≥6 months)
- •Other liver diseases, such as autoimmune liver diseases, viral hepatitis, etc
- •with contraindications of glucocorticoid
研究组 & 干预措施
glucocorticoid+hepatoprotectant group
Experimental
glucocorticoid 0.4mg/kg/d+hepatoprotectant for 7d
干预措施: Glucocorticoids+hepatoprotectant (Drug)
hepatoprotectant group
Active Comparator
hepatoprotectant for 7d
干预措施: hepatoprotectant (Drug)
结局指标
主要结局
percentage of patients that AST or ALT decline 25% at day 4
时间窗: Change from Baseline ALT and AST at day4
AST or ALT decline 25% at day 4
次要结局
- percentage of patients that AST or ALT decline 50% at day 8(Change from Baseline ALT and AST at day8)
- the time needed when TBIL decline 50%(up to 2 weeks)
- relapse rate in 12 months after drug withdrawal(12 months after drug withdrawal)
- mortality in 12 months after drug withdrawal(12 months after drug withdrawal)
- incidence of side effects(up to 2 years)
研究者
Li Yang
professor
West China Hospital
研究点 (1)
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