NCT03458624Unknown不适用
Observational Study to Evaluate the Safety and Efficacy of FURESTEM-AD Inj. in Moderate to Severe Atopic Dermatitis Patients Who Participated in Phase 1/2a Clinical Trial of FURESTEM-AD Lnj.
Kang Stem Biotech Co., Ltd.1 个研究点 分布在 1 个国家目标入组 14 人开始时间: 2016年7月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 14
- 试验地点
- 1
- 主要终点
- Evaluate the number of adverse events Safety of FURESTEM-AD Inj.
研究概览
简要总结
Observational Study to Assess the Safety and Efficacy of FURESTEM-AD lnj. In moderate to Atopic Dermatitis
详细描述
This is a observational study, single center, open label, study of safety and Efficacy of FURESTEM-AD Inj. in subjects with moderate to severe Atopic Dermatitis.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 19 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects participating in this observational study originally participated in study FURESTEM-RA Inj.[NCT02221258]
- •Subject who understands and voluntarily sign an informed consent form
排除标准
- •In case follow-up is not possible from end of clinical trial Phase 1/2a to end of this study period
结局指标
主要结局
Evaluate the number of adverse events Safety of FURESTEM-AD Inj.
时间窗: 3 years
The severity of each adverse enent was classified according to CTCAE v4.0
次要结局
- Percentage of patients who decreased more than 50% in SCORAD(SCORing of Atopic Dermatitis) INDEX compared to Phase 2a clinical trial baseline(3 years)
- Variation of SCORAD Total Score as contrasted with Phase 2a clinical trial baseline value or Phase 2a clinical trial closing value(3 years)
- Percentage of subjects whose IGA(Investigator's Global Assessment) evaluation results were reduced to zero or one point(3 years)
- Variation of serum Total IgE as contrasted with Phase 2a clinical trial baseline value or Phase 2a clinical trial closing value(3 years)
- Variation of EASI(Eczema area and severity index) as contrasted with Phase 2a clinical trial baseline value or Phase 2a clinical trial closing value(3 years)
研究者
研究点 (1)
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