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临床试验/EUCTR2021-002253-29-DE
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

Dr. Falk Pharma GmbH0 个研究点目标入组 160 人开始时间: 2022年1月25日最近更新:
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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