Last updated on March 2019

Octagam 5% Versus Comparator Post Marketing Trial


Brief description of study

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 Study 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.

Clinical Study Identifier: NCT01859754

Contact Investigators or Research Sites near you

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Mikaela Grupp

Octapharma Research Site
Granada Hills, CA United States

Mikaela Grupp

Octapharma Research Site
Irvine, CA United States

Mikaela Grupp

Octapharma Research Site
Redlands, CA United States

Mikaela Grupp

Octapharma Research Site
Centennial, CO United States

Mikaela Grupp

Octapharma Research Site
Albany, GA United States

Mikaela Grupp

Octapharma Research Site
Springfield, IL United States

Mikaela Grupp

Octapharma Research Site
Wichita, KS United States

Mikaela Grupp

Octapharma Research Site
Fort Mitchell, KY United States

Mikaela Grupp

Octapharma Research Site
Plymouth, MN United States

Mikaela Grupp

Octapharma Research Site
Omaha, NE United States

Mikaela Grupp

Octapharma Research Site
East Setauket, NY United States

Mikaela Grupp

Octapharma Research Site
New York, NY United States

Mikaela Grupp

Octapharma Research Site
Columbus, OH United States

Mikaela Grupp

Octapharma Research Site
Toledo, OH United States

Mikaela Grupp

Octapharma Research Site
Pawtucket, RI United States

Mikaela Grupp

Octapharma Research Site
Nashville, TN United States

Mikaela Grupp

Octapharma Research Site
Dallas, TX United States

Mikaela Grupp

Octapharma Research Site
Irving, TX United States

Mikaela Grupp

Octapharma Research Site
Roswell, GA United States

Mikaela Grupp

Octapharma Research Site
Farmington Hills, MI United States

Mikaela Grupp

Octapharma Research Site
Kinston, NC United States

Mikaela Grupp

Octapharma Research Site
Mayfield Heights, OH United States

Mikaela Grupp

Octapharma Research Site
Anderson, SC United States

Mikaela Grupp

Octapharma Research Site
Amarillo, TX United States

Mikaela Grupp

Octapharma Research Site
Los Angeles, CA United States

Mikaela Grupp

Octapharma Research Site
Fort Wayne, IN United States

Recruitment Status: Closed


Brief Description Eligibility Contact Research Team


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