Effect of Subcutaneous Immunoglobulin (IgSC) Gammanorm® on the Distribution of IgG Subclasses and on the Humoral Immunity of Patients With Secondary Immunodeficiency.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Octapharma
- 入组人数
- 102
- 试验地点
- 6
- 主要终点
- Distribution of difference subclasses of IgGs with respect to subcutaneous immunoglobulin treatment
研究概览
简要总结
Patients with Myeloma or CLL with severe secondary hypogammaglobinemia and recurrent infections will be included in this study; for whom an IgSC treatment was prescribed. The IgSC prescription will be the decision of the treating physician. Patient care and follow up will be performed according to the current clinical practice and the recommendations of HAS.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
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
- •Adult male or female (≥18 years old), Myeloma or Chronic Lymphocytic Leukemia patients with secondary hypogammaglobinemia and recurring infections.
- •Patients with indication for IgSC treatment but who have not started the treatment yet. Prior IgSC or IgIV treatment 6 months before inclusion is accepted (with a washout period of 6 months minimum).
- •Patient having received all the necessary information about the study and signed an informed consent document.
排除标准
- •Patient having initiated an IgSC treatment.
- •Patient having received IgSC or IgIV treatment within 6 months prior to inclusion.
- •Incapacity/Inability to attend the follow-up visits.
- •Patient refusing to participate in the study.
- •HIV positive patients.
- •Incapacity to understand the study objective and process, to agree or to give informed consent to participate in the study.
- •Pregnant or breast-feeding women
研究组 & 干预措施
Gammanorm
Patients on Gammanorm per standard of care
干预措施: Gammanorm (Drug)
Other Subcutaneous Immunoglobulin
Patients on subcutaneous immunoglobulin treatments other than Gammanorm
干预措施: Other Subcutaneous Immunoglobulins (Drug)
结局指标
主要结局
Distribution of difference subclasses of IgGs with respect to subcutaneous immunoglobulin treatment
时间窗: 12 months
Distribution of difference subclasses of IgGs with respect to subcutaneous immunoglobulin treatment collected as biological data including immunoglobulins (quantitative dosage and electrophoresis), lymphocytes, CD14 monocytes, polynuclear neutrophils, polynuclear basophils and dendritic cells
次要结局
- Hospitalizations due to infections(12 months)
- IgSC treatment(12 months)
- Predictive Factors of Recurrent Infections(12 months)
- Change in immune system(12 months)
- IgG levels(12 months)
- Antibiotic Consumption(12 months)
- Safety of IgSCs to characterize the IgSCs safety, including the adverse events that are not considered to be related to the study treatment(12 months)
- Bacterial Infections(12 months)
- Lymphocytic Repertoire analyzing the evolution of the lymphocytic repertoire (CD3, CD4, CD8, CD19, CD56, and CD27).(12 months)