ATGAM INTRAVENOUS INFUSION 250mg GENERAL INVESTIGATION
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- Pfizer
- 入组人数
- 1
- 试验地点
- 1
- 主要终点
- Number of participants with adverse drug reactions (ADRs)
研究概览
简要总结
The objective of this study is to confirm the safety of ATGAM in patients with moderate to severe aplastic anemia under the actual use in Japan.
The registration criteria is patients with moderate to severe aplastic anemia who receive ATGAM.
The observation period is 24 weeks (6 months) from the start of administration (Day 1). However, in cases where treatment has been completed or discontinued less than 24 weeks after the start of administration, observation is continued until completion (discontinuation) of treatment.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with moderate to severe aplastic anemia who receive ATGAM
排除标准
- •No exclusion criteria is set out in this study.
研究组 & 干预措施
Anti-human thymocyte immunoglobulin, equine
Patients with moderate to severe aplastic anemia who receive ATGAM (Anti-human thymocyte immunoglobulin, equine)
干预措施: Anti-human thymocyte immunoglobulin, equine (Drug)
结局指标
主要结局
Number of participants with adverse drug reactions (ADRs)
时间窗: 24 weeks (6 months) from the start of administration (Day 1)
次要结局
未报告次要终点