Phase II Study of the Levamisole Combined With Cyclosporine A in Patients With Classic Paroxysmal Nocturnal Hemoglobinuria
试验速览
- 阶段
- 2 期
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Number of patients in each group in complete or partial remission
研究概览
简要总结
Paroxysmal nocturnal hemoglobinuria is an acquired chronic hemolytic anemia,this study is designed to evaluate the safety and efficacy of Levamisole combined with cyclosporine A in patients with classic paroxysmal nocturnal hemoglobinuria.
详细描述
Paroxysmal nocturnal hemoglobinuria (PNH) is an acquired clonal disorder of the hematopoietic stem cell characterized by intravascular hemolysis, hemoglobinuria, anemia, and thrombosis, Patients may be at high risk of thrombosis and may develop bone marrow failure or aplastic anemia, with low white blood cell and platelet counts,because the manifestation and pathologic processes are complicate,the treatment is very difficult,this study is designed to evaluate the safety and efficacy of Levamisole combined with cyclosporine A in patients with classic paroxysmal nocturnal hemoglobinuria
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical and biochemical signs of classic Paroxysmal Nocturnal Hemoglobinuria
- •Diagnosis confirmed by Ham's test or Flow cytometry Patients have any Flow cytometry data
- •patient should complete levamisole study for at least half a year
排除标准
- •Active infection which requires antibiotic treatment
- •Pregnant or lactating women
- •Epilepsy and mental illness
- •Kidney and liver function abnormal
- •patient who terminate ealy from levamisole study
研究组 & 干预措施
Levamisole+cyclosporin A+Glucocorticoids
Levamisole+cyclosporin A+Glucocorticoids
干预措施: Levamisole+cyclosporin A+Glucocorticoids (Drug)
cyclosporin A+Glucocorticoids
cyclosporin A+Glucocorticoids
干预措施: cyclosporin A+Glucocorticoids (Drug)
Glucocorticoids
Glucocorticoids
干预措施: Glucocorticoids (Drug)
结局指标
主要结局
Number of patients in each group in complete or partial remission
时间窗: 6 months
she got blood transfusion-independent,the hemoglobin became higher
次要结局
- Side effects(6 months)
研究者
Yizhou Zheng
Vice director of the therapeutic centre of anemic diseases
Institute of Hematology & Blood Diseases Hospital, China