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

Start Over

Octapharma Research Site

Granada Hills, CA United States

Octapharma Research Site

Irvine, CA United States

Octapharma Research Site

Redlands, CA United States

Octapharma Research Site

Centennial, CO United States

Octapharma Research Site

Albany, GA United States

Octapharma Research Site

Springfield, IL United States

Octapharma Research Site

Wichita, KS United States

Octapharma Research Site

Fort Mitchell, KY United States

Octapharma Research Site

Plymouth, MN United States

Octapharma Research Site

Omaha, NE United States

Octapharma Research Site

East Setauket, NY United States

Octapharma Research Site

New York, NY United States

Octapharma Research Site

Columbus, OH United States

Octapharma Research Site

Toledo, OH United States

Octapharma Research Site

Pawtucket, RI United States

Octapharma Research Site

Nashville, TN United States

Octapharma Research Site

Dallas, TX United States

Octapharma Research Site

Irving, TX United States

Octapharma Research Site

Roswell, GA United States

Octapharma Research Site

Farmington Hills, MI United States

Octapharma Research Site

Kinston, NC United States

Octapharma Research Site

Mayfield Heights, OH United States

Octapharma Research Site

Anderson, SC United States

Octapharma Research Site

Amarillo, TX United States

Octapharma Research Site

Los Angeles, CA United States

Octapharma Research Site

Fort Wayne, IN United States

Recruitment Status: Closed


Brief Description Eligibility Contact Research Team


Receive Emails About New Clinical Trials!

Sign up for our FREE service to receive email notifications when clinical trials are posted in the medical category of interest to you.