Safety and Efficiency Study of Low-dose IL-2 Treatment in Macrophage Activation Syndrome
试验速览
- 阶段
- 1 期
- 入组人数
- 6
- 试验地点
- 1
- 主要终点
- Disease activity on the HScore (a Score for the Diagnosis of Reactive Hemophagocytic Syndrome)
研究概览
简要总结
The investigators evaluate the effectiveness and safeness of low-dose Recombinant Human Interleukin-2 （rhIL-2） for MAS.
详细描述
Autoimmune-associated macrophage activation syndrome (MAS), also known as secondary hemophagocytic lymphohistiocytosis (HLH), is a rapidly progressing life-threatening disease. VP16 (Etoposide) is a well-known standard therapy, but is associated with substantial adverse effects, especially myelosuppression and infections , while steroids and ciclosporin (CSA) are not always efficient in this disease.
The investigators hypothesized that low- dose IL-2 could be a novel therapy in MAS. This clinical study will test the efficacy and safety of low dose IL-2 treatment in MAS. The investigators perform a single-centre pilot trial with rhIL-2 in MAS. The investigators evaluate the effectiveness and safeness of low-dose IL-2 for MAS.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 16 Years 至 65 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of Macrophage Activation Syndrome（MAS）
- •MAS secondary to autoimmune disease, such as Adult onset still's disease (AOSD), juvenile rheumatoid arthritis (JRA) or Systemic Lupus Erythematosus (SLE).
排除标准
- •Primary MAS
- •Secondary to neoplasia, lymphoma and virus infection
- •pre-treatment with Cyclosporine A
- •relevant cardiac, pulmonary, neurologic or psychiatric disease
- •life-Vaccination within 4 weeks before begin with study medication
- •pregnant or breast-feeding
- •weight under 45kg or more than 80kg
研究组 & 干预措施
Low-does rhIL-2 therapy
Recombinant Human Interleukin-2 (RhIL-2) was administered subcutaneously at a dose of 1 million IU every other day for 4 weeks
干预措施: Interleukin-2 (Drug)
结局指标
主要结局
Disease activity on the HScore (a Score for the Diagnosis of Reactive Hemophagocytic Syndrome)
时间窗: 1month
Examination of the therapeutic effects (improvement in HScore) of low dose IL-2 in patients with MAS
次要结局
未报告次要终点