KCT0005206尚未招募未知
A Multi-center, Randomized, Double-blind, Placebo-controlled, Phase IIa Clinical Trial to Evaluate the Safety and Explore the Efficacy of UN03 for Non-alcoholic Steatohepatitis (NASH) with Fibrosis
Hanyang University Seoul Hospital0 个研究点目标入组 50 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 尚未招募
- 发起方
- 入组人数
- 50
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional Study
入排标准
- 年龄范围
- 19(Year) 至 75(Year)（—）
- 性别
- All
入选标准
- •1) Men and women aged 19 and over
- •2) Those who meet all of the following criteria
- •? liver fat on MRI-PDFF test
- •? fibrosis in the liver by MRE test
- •3) Those who are willing to maintain the same lifestyle habits (exercise, alcohol intake, diet, etc.) maintained for at least 4 weeks before screening
- •4) A person who voluntarily consents in writing to participate in this clinical trial
排除标准
- •1) Those who have confirmed the following history of liver disease at the time of screening
- •? Acute and chronic viral hepatitis
- •? decompensated cirrhosis or liver cancer
- •2) Those who have confirmed the following medical history or surgery at the time of screening
- •? Severe heart disease or severe cerebrovascular disease
- •? malignant tumor
- •3) The following accompanying diseases were identified at the time of screening
- •? Hypertension (systolic blood pressure> 180 mmHg or diastolic blood pressure> 110 mmHg)
- •? Type 1 diabetes or uncontrolled type 2 diabetes
研究者
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