NCT02926300Unknown不适用
Extension Study, An Open-labelled, Multi Center, Comparative Phase I/IIa Clinical Trials to Evaluate the Efficacy and Safety of FURESTEM-CD Inj. in Patients With Moderately Active Crohn's Disease
Kang Stem Biotech Co., Ltd.7 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2015年11月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 24
- 试验地点
- 7
- 主要终点
- all kinds of adverse events which occur during the clinical sutdy
研究概览
简要总结
The purpose of this clinical trial is to evaluate long-term safety and efficacy in patients who has history of FURESTEM-CD injection at least once.
详细描述
This study is an extended study of KSTHD_FURESTEM-CD phase 1 / 2a clinical trials in patients with moderate active Crohn's disease who had received at least once a FURESTEM-CD injection. The purpose of this clinical trial is to evaluate long-term safety and efficacy in patients for approximately 36 months (144 weeks).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 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
- •patients who has history of FURESTEM-CD Inj. injection at least once.
- •patients who understand and voluntarily sign an informed consent form.
排除标准
- •any other condition which the Principle Investigator judges would make subject unsuitable for study participation.
结局指标
主要结局
all kinds of adverse events which occur during the clinical sutdy
时间窗: 114 weeks
Safety outcome
次要结局
- ratio of patients who reduce CDAI over 70 as contrasted witd baseline(V7)(114 weeks)
- ratio of patients who is applicable to CDAI<150(114 weeks)
研究者
研究点 (7)
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