NCT06298630招募中不适用
Long-term Follow-up Study of BRL-101 in the Treatment of Transfusion-dependent β-thalassemia
Bioray Laboratories7 个研究点 分布在 1 个国家目标入组 45 人开始时间: 2024年12月8日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 45
- 试验地点
- 7
- 主要终点
- Incidence of hematologic malignancies
研究概览
简要总结
Observe long-term safety risk and long-term efficacy after intravenous infusion of BRL-101 in TDT subjects.
详细描述
Observe long-term delayed safety risks such as emerging neoplasms, emerging haematological disorders, and long-term efficacy after intravenous infusion of BRL-101 in TDT subjects.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 3 Years 至 35 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Provision of written informed consent for this study by subjects, or as applicable, subject's parent(s)/legal guardian(s)
- •Treated with BRL-101 for therapy of transfusion-dependent β-thalassemia.
排除标准
- •- There are no exclusion criteria for this study
结局指标
主要结局
Incidence of hematologic malignancies
时间窗: Up to 15 years post-drug product infusion
Such as new lymphoma, leukemia, MDS, etc.
Frequency, grade, and relationship of SAEs
时间窗: Within 2 years to 5years after BRL-101 Infusion
Frequency, grade, and relationship to BRL-101 of SAEs following BRL-101 reinfusion.
次要结局
未报告次要终点
研究者
研究点 (7)
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