JPRN-jRCT2031210210招募中3 期
A master protocol for a Phase 3, multicenter, open-label, long-term extension study to evaluate the long-term efficacy and safety of mirikizumab in children and adolescents with moderate-to-severe ulcerative colitis or Crohn's Disease - I6T-MC-AMAZ
Masaki Takeshi0 个研究点目标入组 5 人开始时间: 2021年7月28日最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 5
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- ot applicable 至 ot applicable（—）
- 性别
- All
入选标准
- •Participants from prior studies who have had at least one study drug administration and have not had early termination of study drug.
- •-Female participants must agree to contraception requirements.
排除标准
- •-Participants must not have developed a new condition, including cancer in the originator study.
- •-Participants must not have any important infections including, but not limited to, hepatitis B, hepatitis C, HIV/AIDS, and active tuberculosis (TB) during either originator study.
- •-Participants may not have received surgery for UC in the originator study or are likely to require surgery for treatment of UC during the study.
- •-Requires parenteral nutrition delivered by central vein and/or central venous catheter for venous access.
研究者
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