Postmarketing Requirement Non-Interventional 2-armed Study to Evaluate the Safety of Octagam® Immune Globulin Intravenous (Human) 5% Liquid Preparation, With a Special Emphasis on Monitoring, Analysis and Reporting of Thromboembolic Events
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Octapharma
- 入组人数
- 623
- 试验地点
- 1
- 主要终点
- Incidence Rate of Thromboembolytic events
研究概览
简要总结
Study Design:
This is a 2 arm non-interventional trial that will compare the occurrence of adverse drug reactions between Octagam 5% and other marketed IVIG infusion treatments.
详细描述
This Post Marketing Study is a prospective, 2-armed, multicenter, non-interventional study. Patients will either be administered the brand of IGIV therapy ordered by their prescribing physician, or for patients issued unspecified or generic prescriptions of IGIV therapy, octagam® 5% or another brand of IGIV therapy will be provided by the Investigator according to federal, state and local regulations and good clinical practice (GCP) guidelines.
The primary objective is to assess and evaluate the safety profile of octagam® 5% during or after administration under routine clinical use for all labeled indications, with a special emphasis on the occurrence of TEEs. The incidence of TEEs in patients receiving octagam® 5% will be compared with the incidence rate in a matching concurrent control group of patients receiving other IGIVs for routine clinical use.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 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
- •Male and female patients aged 18 years.
- •Patients with confirmed diagnosis of Primary Humoral Immunodeficiency (PI) as stated by the World Health Organization and requiring immunoglobulinreplacement therapy due to hypogammaglobulinemia or agammaglobulinemia.
- •Patients on regular treatment (every 3 to 4 weeks) with low dose IGIV (1 g/kg) for a period of at least 6 months without changing the brand.
排除标准
- •Patients with a history of TEEs within the previous 24 months.
- •Patients with a regular treatment frequency of more than once every 3 to 4 weeks.
结局指标
主要结局
Incidence Rate of Thromboembolytic events
时间窗: 4 months
次要结局
未报告次要终点
