Cyclosporine As a Second-line Treatment of Primary Autoimmune Hemolytic Anemia
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- the proportion of partial response
研究概览
简要总结
the cyclosporine showed efficacy in many immune cytopenic diseases in the light of numerous case reports and retrospective data. This study compares cyclosporin versus rituximab in steroid-refractory anemia.
详细描述
Auto-immune hemolytic anemia (AIHA) is a heterogeneous syndrome in adults. This disease is associated with significant morbidity-mortality. First-line treatment with prolonged corticosteroid is well identified but there is not enough data about cyclosporine treatment in case of resistance or dependence on steroids.
the cyclosporine showed efficacy in many immune cytopenic diseases in the light of numerous case reports and retrospective data. This drug is cheap, licensed in immunologic diseases, and does not expose to major infections. So, we compare cyclosporin versus rituximab in steroid-refractory anemia.
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
- None
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
- •Patients aged more than 18 years old from any sex with a diagnosis of primary warm autoimmune hemolytic anemia (AIHA) based on the presence of hemolytic anemia and serological evidence of anti-erythrocyte antibodies, detectable by the direct antiglobulin test who have disease progression or failure after treatment with steroid therapy, or who are intolerant to treatment, or who refuse standard treatment.
- •No evidence of a lymphoproliferative malignancy or other autoimmune-related underlying conditions.
排除标准
- •any contraindications to the drugs of the study.
- •any identified secondary cause of the AIHA.
- •pregnant or lactating women.
研究组 & 干预措施
Cyclosporine
2.5-5mg/kg of cyclosporine daily for 3 months
干预措施: Cyclosporine (Drug)
Rituximab
375 mg/ m2 weekly dose for a maximum of 4 weeks.
干预措施: Rituximab (Drug)
结局指标
主要结局
the proportion of partial response
时间窗: 3months
(Hb ≥10 g/dL or at least 2 g/dL increase in Hb, and no transfusion requirement
the proportion of complete response
时间窗: 3months
Hb ≥12 g/dL and normalization of all hemolytic markers
次要结局
- rate of adverse events(3months)
研究者
Ghada E. M. Abdallah
lecturer in internal medicine department of faculty of medicine,Assiut university
Assiut University