NCT00308438已完成2 期
An Open Label Extension Study of the Safety and Efficacy of ALX-0600 in Subjects With Crohn's Disease Who Completed the Pilot Study Protocol CL0600-008
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Shire
- 入组人数
- 67
- 试验地点
- 24
- 主要终点
- The percentage of subjects who are in remission (CDAI score less than 150) at week 12 of this study.
研究概览
简要总结
The purpose of the study is to determine whether an investigational compound, ALX-0600, is safe and effective in treating Crohn's Disease.
详细描述
The study is sixteen weeks in duration and there are twelve weeks of once-daily injections into your abdomen or thigh. There are a total of five visits.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Subjects must have completed participation in the Pilot Active Crohn's Disease Study.
- •Subjects must continue to meet all inclusion criteria for Pilot Active Crohn's Disease Study with the following exceptions:
- •CDAI score greater than 220
- •Stool samples not required
- •C-reactive protein levels are not an exclusion criterion
排除标准
- •Subject must continue to meet all exclusion criteria for Pilot Active Crohn's Disease Study with the following exceptions:
- •Participation in a clinical study of an experimental drug or device within 30 days before signing consent.
研究组 & 干预措施
1
Experimental
All subjects in the study dosed at 0.1 mg/kg teduglutide
干预措施: Teduglutide (ALX-0600) (Drug)
结局指标
主要结局
The percentage of subjects who are in remission (CDAI score less than 150) at week 12 of this study.
时间窗: 12 weeks after start of study
次要结局
- The percentage of subjects (of those who achieved response in CL0600-008) who, at week 12 of this study, maintain the response they previously achieved.(12 weeks after study start)
- The percentage of subjects who did not respond in CL0600-008 who do respond at week 12 in this study(12 weeks after study start)
研究者
研究点 (24)
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