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临床试验/NCT01859754
NCT01859754已完成不适用

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

Octapharma1 个研究点 分布在 1 个国家目标入组 623 人开始时间: 2013年5月21日最近更新:
适应症

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

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

研究者

发起方
Octapharma
申办方类型
Industry
责任方
Sponsor

研究点 (1)

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