Octagam 5% Versus Comparator Post Marketing Trial



Status:Recruiting
Conditions:Infectious Disease, HIV / AIDS
Therapuetic Areas:Immunology / Infectious Diseases
Healthy:No
Age Range:18 - Any
Updated:8/3/2018
Start Date:May 2013
End Date:May 2019
Contact:Mikaela Grupp
Email:ctgov@clinicalresearchmgt.com
Phone:866-337-1868

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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

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.

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.

Inclusion Criteria:

1. Male and female patients aged 18 years.

2. 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.

3. 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.

Exclusion Criteria:

1. Patients with a history of TEEs within the previous 24 months.

2. Patients with a regular treatment frequency of more than once every 3 to 4 weeks.
We found this trial at
26
sites
Albany, Georgia 31701
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Amarillo, Texas 79124
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Anderson, South Carolina 29621
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Anderson, SC
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Centennial, Colorado 80112
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Centennial, CO
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3467 Cleveland Avenue
Columbus, Ohio 43221
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Columbus, OH
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Dallas, Texas 75231
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Dallas, TX
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East Setauket, New York 11733
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East Setauket, NY
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Farmington Hills, Michigan 48334
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Farmington Hills, MI
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Fort Mitchell, Kentucky 41017
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Fort Mitchell, KY
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Fort Wayne, Indiana 46815
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Fort Wayne, IN
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Granada Hills, California 91344
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Granada Hills, CA
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Irvine, California 92697
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Irvine, CA
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Irving, Texas 75014
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Irving, TX
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Kinston, North Carolina 28501
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Kinston, NC
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Los Angeles, California 90095
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Los Angeles, CA
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Mayfield Heights, Ohio 44124
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Mayfield Heights, OH
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Nashville, Tennessee 37232
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Nashville, TN
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New York, New York 10012
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New York, NY
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Omaha, Nebraska 68124
Phone: 201-604-1155
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Omaha, NE
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Pawtucket, Rhode Island 02860
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Pawtucket, RI
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Plymouth, Minnesota 55446
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Plymouth, MN
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Redlands, California 92373
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Redlands, CA
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Roswell, Georgia 30076
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Roswell, GA
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Springfield, Illinois 62701
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Springfield, IL
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Toledo, Ohio 43617
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Toledo, OH
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Wichita, Kansas 67201
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Wichita, KS
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