NCT01859754

Octagam 5% Versus Comparator Post Marketing Trial

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 623 (actual)
• Sponsor: Octapharma · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Primary Immune Deficiency Disorder

Interventions

Type	Name	Description
BIOLOGICAL	Octagam 5%	Intravenous immunoglobulin 5%
BIOLOGICAL	Other marketed IVIG product	Any intravenous immunoglobulin marketed product approved for the treatment of PID

Timeline

• Start date: 2013-05-21
• Primary completion: 2019-05-22
• Completion: 2019-05-22
• First posted: 2013-05-22
• Last updated: 2019-06-10

Locations

27 sites across 1 country: United States