Immunopathology of Autoimmune Hemolytic Anemia: an Open, Prospective and Multicenter Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 27
- 试验地点
- 5
- 主要终点
- physiological parameter : percentage of inhibiting LT proliferation inhibition
研究概览
简要总结
Autoimmune hemolytic anemia (AIHA) is an auto-immune disease mediated by specific antibodies targeting red blood cells. Its pathogenesis is not completely understood, and the role of T cells have been rarely studied.
The aim of this study is to compare the frequency of circulating T cells, T cell polarization and functions, notably regulatory T cells, during warm AIHA by comparison to healthy controls.
The role of treatments, such as steroids, will also be determined in patients with warm AIHA.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients diagnosed with primary warm Autoimmune Hemolytic Anemia (wAIHA)
- •Secondary AHAI (infections, hematological diseases, systemic diseases)
- •Naive of treatment for hemolytic anemia or in relapse
- •Older than 16
- •Able to understand written and spoken French
- •who have provided written informed consent
- •INCLUSION CRITERIA for CONTROLS
- •Persons without auto-immune disease, cancer or active infection.
- •Older than 16
- •Able to understand written and spoken French
- •who have provided written informed consent
排除标准
- •Cold agglutinin disease
- •Pregnancy
- •Persons without national health insurance
- •Exclusion Criteria for Controls:
- •Subjects treated with corticosteroids or immunosuppressants
- •Pregnancy
- •Persons without national health insurance
研究组 & 干预措施
Patients
干预措施: blood samples (Biological)
controls
干预措施: blood samples (Biological)
结局指标
主要结局
physiological parameter : percentage of inhibiting LT proliferation inhibition
时间窗: Change from baseline to 3 months
physiological parameter : blood level of regulatory T cells (Treg, CD4+CD25HighFoxp3+)
时间窗: Change from baseline to 3 months
次要结局
未报告次要终点