NCT04870346进行中（未招募）不适用
Long Term Follow-up Observational Study After Clinical Trials of AMG531 (Romiplostim) in Patients With Untreated Aplastic Anemia
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Hematological response at up to 5 years after the start of romiplostim treatment in Study 531-003/531-004
研究概览
简要总结
To evaluate the long-term efficacy and safety after the end of romiplostim treatment by observation [up to 5 years] of patients who were registered for Study 531-003/531-004 in immunosuppressive therapy-naïve patients with aplastic anemia.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients whose written consent to participate in this research was obtained among patients registered for Study 531-003/531-004
- •Of the patients who died before their consent to participate in this research was obtained among those registered for Study 531-003/531-004, patients whose legally authorized representatives such as their family had given the consent or patients whose legally authorized representatives had not refused in the disclosure of information by opt-out
- •Of the patients who died before their consent to participate in this research was obtained among those registered for Study 531-003/531-004, patients, patients for whom the consent process exemption was approved by the Ethics Review Committee, etc. of the participating medical institutions at the participating medical institutions in the countries without the opt-out system
排除标准
- •Patients who are judged by the investigator or sub-investigator to be unfavorable for participation in this research
结局指标
主要结局
Hematological response at up to 5 years after the start of romiplostim treatment in Study 531-003/531-004
时间窗: 5 years
Hematological response at 2 years after the start of romiplostim treatment in Study 531-003/531-004
时间窗: 2 years
次要结局
- The duration of hematological response, and the presence or absence of occurrence of new chromosomal abnormality or transformation to AML/MDS.(52, 78, 104, 130, 156, 182, 208, 234, 260 weeks)
研究者
研究点 (1)
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