A Study on the Dynamics and Grading Criteria Construction of Adverse Reactions to ATG/ALG Therapy in Aplastic Anemia
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Percentage of patients with serum sickness and its severity
研究概览
简要总结
This prospective, single-center, observational cohort study aims to systematically observe and describe the clinical characteristics of adverse reactions in patients with aplastic anemia undergoing ATG (Anti-Thymocyte Globulin) /ALG (Anti-Lymphocyte Globulin) treatment, providing a data foundation for the development of relevant management strategies. This study plans to enroll 200 aplastic anemia patients undergoing ATG/ALG treatment
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
- •Meet the diagnostic criteria for aplastic anemia (Camitta criteria);
- •Receiving ATG/ALG immunosuppressive therapy for the first time;
排除标准
- •Previously received hematopoietic stem cell transplantation;
- •Aplastic anemia patients receiving ATG/ALG as part of transplant conditioning regimen;
研究组 & 干预措施
Patients with aplastic anemia undergoing ATG or ALG treatment
干预措施: ATG/ALG (Drug)
结局指标
主要结局
Percentage of patients with serum sickness and its severity
时间窗: Within 4 weeks after ATG/ALG infusion
Use Common Terminology Criteria for Adverse Events (CTCAE) Version 5 to assess its severity
次要结局
- Percentage of patients with liver and kidney function damage and its severity(During ATG/ALG infusion (typically from d1 to d6) and within 4 weeks after ATG/ALG infusion)
- Percentage of patients with infusion reaction and its severity(During ATG/ALG infusion(typically from d1 to d6))
研究者
Jun Shi
Director of the Red Blood Cell Diseases Center & Director of the Regenerative Medicine Clinic
Institute of Hematology & Blood Diseases Hospital, China