NCT01314079已完成不适用
Follow-up Study to Evaluate the Sustained Efficacy and Safety for the Patients With Adipoplus Injected in Phase II Clinical Trials(ANTG-ASC-202)
Anterogen Co., Ltd.3 个研究点 分布在 1 个国家目标入组 37 人开始时间: 2010年4月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 37
- 试验地点
- 3
- 主要终点
- Number of patients with Sustained efficacy of complete closure of fistula
研究概览
简要总结
This is an open follow-up clinical trials to evaluate a sustained efficacy and safety of Adipoplus inj. for 10 months (12 months after final dose injection)after Phase II clinical trial.
研究设计
- 研究类型
- Observational
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •the patients who have participated in ANTG-ASC-202 clinical trial
- •the patients who have experienced with Adipoplus in ANTG-ASC-202 trials
- •the patients who submit written consents and is able to obey requirements of trials
排除标准
- •pregnant or breast feeding
- •autoimmune disease other than Crohn's disease
- •infectious diseases including HBV, HCV or HIV
- •who is not willing to use effective contraceptive methods during the study.
- •active tuberculosis
- •moderate to severe active or worsened Crohn's disease
- •who have received Infliximab during or after ANTG-ASC-202 trial
结局指标
主要结局
Number of patients with Sustained efficacy of complete closure of fistula
时间窗: Month 4, 10
Proportion of patients whose fistula has been completely closed.
次要结局
- Number of patients with sustained efficacy of closure of fistula(Month 2, 4, 10)
- Number of patients with any adverse event(Month 2, 4, 10)
- Grade of Investigator's satisfaction(Month 2, 4, 10)
研究者
研究点 (3)
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