Postmarketing Requirement (PMR) 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 (TEEs) (GAM5-28)

Study identification

• EU PAS number:
  EUPAS10738
• Study ID:
  10739
• Official title and acronym:
  Postmarketing Requirement (PMR) 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 (TEEs) (GAM5-28)
• DARWIN EU® study:
  No
• Study countries:
  United States
• Study description:
  This observational study compares the incidence of TEEs in PID patients who receive regularly prescribed IVIG all 3 to 4 weeks in two groups: Octagam 5% vs. other brands.
• Study status:
  Ongoing

Research institutions and networks

Institutions

Octapharma

Study timelines

Date when funding contract was signed

Planned:29/04/2011

Actual:29/04/2011

Study start date

Actual:01/05/2013

Date of final study report

Planned:29/05/2020

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Octapharma

Regulatory

• Was the study required by a regulatory body?:
  Yes