EUCTR2021-002253-29-DE进行中(未招募)1 期
Double-blind, randomized, placebo-controlled, phase II dose-finding study comparing different doses of ZED1227 capsules with placebo in the treatment of non-alcoholic fatty liver disease (NAFLD) with significant fibrosis
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中(未招募)
- 入组人数
- 160
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •- Has provided signed informed consent
- •- Is a male or female = 18 and < 75 years of age
- •- Has diagnosed NAFLD
- •- Has diagnosed significant fibrosis (stages 2 or 3)
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •- Has a history of significant alcohol consumption (an average of > 20 g/d in females and > 30 g/d in males)
- •- Has a history or presence of any other significant concomitant liver diseases
- •- Has diagnosed type 1 diabetes mellitus (T1DM)
- •- Has presence of cirrhosis
研究者
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