EUCTR2014-003855-76-SK进行中（未招募）1 期
An open-label extension and safety monitoring study of patients with moderately to severely active Crohn`s disease previously enrolled in the Etrolizumab phase III protocol GA29144
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 1,150
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Part 1 Open-label Extension:
- •-Patients previously enrolled in etrolizumab Phase III study GA29144 who meet the eligibility criteria for open-label etrolizumab as described in the protocol
- •Part 2 Safety Monitoring:
- •-Patients who participated in etrolizumab Phase III study GA29144 and are not eligible or choose not to enter Part 1
- •-Patients who transfer from Part 1
- •-Completion of the 12-week safety follow-up in either GA29144 or GA29145, Part 1 (OLE), as applicable,-period prior to entering
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 1100
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 50
排除标准
- •Part 1 Open-label Extension:
- •-Any new, significant, uncontrolled condition
- •Part 2 Safety Monitoring:
- •-No exclusion criteria
研究者
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