Different Doses of Anti-thymocyte Globin With 2.5 or 3.75mg/kg to Treat Child Severe Aplastic Anemia
试验速览
- 阶段
- 4 期
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- the response and complete remission rate with different doses of ATG to treat child severe aplastic anemia
研究概览
简要总结
Severe acquired aplastic anaemia (SAA) is a life-threatening disease characterized by pancytopenia and hypoplastic bone marrow. Immunosuppressive treatment with antithymocyte globulin (ATG)and cyclosporine remain the standard regimen with response rates of 70% or more and excellent overall survival. However ,there are no clinical trials to illustrate the response and complete remission rate with different doses of ATG.And there are no data reported on children with SAA so far.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 1 Year 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •clinical diagnosis of childhood acquired severe aplastic anemia(SAA)
排除标准
- •clinical diagnosis of no childhood acquired severe aplastic anemia(SAA)
研究组 & 干预措施
high dose ATG,low dose ATG
干预措施: ATG (Drug)
结局指标
主要结局
the response and complete remission rate with different doses of ATG to treat child severe aplastic anemia
时间窗: 1 years
Complete response (CR) was defined as achieving normal levels of hemoglobin adjusted for age, platelet count \>100×109/L, and ANC\>1.5×109/L. Partial response (PR) was defined as transfusion independence, reticulocyte count \>30×109/L, platelet count \>20×109/L, and ANC \>0.5×109/L above the baseline. Persistence of transfusion requirement or death was evidence of no response (NR).
次要结局
- the relapse rate with different doses of ATG to treat child severe aplastic anemia(4-10 years)
研究者
Xiaofan Zhu
Department of Pediatrics, Institute of Hematology and Blood Diseases Hospital
Chinese Academy of Medical Sciences