NCT06073860招募中不适用
Reblozyl® (Luspatercept) Post-Marketing Surveillance in Korean Patients With Myelodysplastic Syndrome or Beta Thalassemia
Bristol-Myers Squibb2 个研究点 分布在 1 个国家目标入组 104 人开始时间: 2024年3月25日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 104
- 试验地点
- 2
- 主要终点
- Number of participants with adverse events (AEs)
研究概览
简要总结
The purpose of this observational study is to assess the real-world safety of luspatercept in Korean participants with myelodysplastic syndrome (MDS) or beta thalassemia. Investigators will enroll participants who will begin treatment with at least 1 dose of luspatercept.
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
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult participants 19 years of age or older
- •Participants who will be treated with luspatercept according to the approved label in the Republic of Korea
- •Participants who sign the informed consent form
排除标准
- •Participants who are prescribed luspatercept for therapeutic indications not approved in the Republic of Korea
- •Participants for whom luspatercept is contraindicated as clarified in the Korean prescribing information approved by the Ministry of Food and Drug Safety
研究组 & 干预措施
Participants with myelodysplastic syndrome or beta thalassemia who will begin luspatercept treatment
干预措施: Luspatercept (Drug)
结局指标
主要结局
Number of participants with adverse events (AEs)
时间窗: Up to 6 months
次要结局
未报告次要终点
研究者
研究点 (2)
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