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Octagam 5% Versus Comparator Post Marketing Trial

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2016 by Octapharma
Information provided by (Responsible Party):
Octapharma Identifier:
First received: May 9, 2013
Last updated: October 17, 2016
Last verified: October 2016

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.

Condition Intervention
Primary Immune Deficiency Disorder
Biological: Octagam 5%
Biological: Other marketed IVIG product

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: 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

Resource links provided by NLM:

Further study details as provided by Octapharma:

Primary Outcome Measures:
  • Incidence Rate of Thromboembolytic events [ Time Frame: 4 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 500
Study Start Date: May 2013
Estimated Study Completion Date: March 2017
Estimated Primary Completion Date: March 2017 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Octagam 5%
Primary Immune Deficiency Syndrome patients receiving Octagam 5% by infusion who have been treated with a marketed IVIG product for at least 6 months.
Biological: Octagam 5%
Intravenous immunoglobulin 5%
Other marketed IVIG product
Primary Immune Deficiency Syndrome patients receiving marketed IVIG product other than Octagam 5% by infusion as treatment for at least 6 months.
Biological: Other marketed IVIG product
Any intravenous immunoglobulin marketed product approved for the treatment of PID

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.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients over 18 years old with Primary Immune Deficiency Syndrome PID receiving marketed IVIG as treatment

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01859754

United States, California
Octapharma Site Completed
Granada Hills, California, United States, 91344
Octapharma Study Site Completed
Irvine, California, United States, 92697
Octapharma Site Completed
Redlands, California, United States, 92373
United States, Colorado
Octapharma Study Site Recruiting
Centennial, Colorado, United States, 80112
Contact: Michael Eppolito    201-604-1155      
United States, Georgia
Octapharma Site Recruiting
Albany, Georgia, United States, 31701
Contact: michael eppolito, mba    201-604-1155   
United States, Illinois
Octapharma Site Recruiting
Springfield, Illinois, United States, 62701
Contact: Michael Eppolito, MBA    201-604-1155   
United States, Kansas
Octapharma Site Recruiting
Wichita, Kansas, United States, 67201
Contact: Michael Eppolito, MBA    201-604-1155   
United States, Kentucky
Octapharma Site Recruiting
Fort Mitchell, Kentucky, United States, 41017
Contact: michael eppolito, MBA    201-604-1155   
United States, Minnesota
Octapharma Site Completed
Plymouth, Minnesota, United States, 55446
Octapharma Site Recruiting
Plymouth, Minnesota, United States, 55447
Contact: Michael Eppolito, MBA    201-604-1155   
United States, Nebraska
Octapharma Site Completed
Omaha, Nebraska, United States, 68124
United States, New York
Octapharma Site Completed
East Setauket, New York, United States, 11733
Octapharma Site Recruiting
New York City, New York, United States, 10012
Contact: Michael Eppolito, MBA    201-604-1155   
United States, Ohio
Octapharma Site Completed
Columbus, Ohio, United States, 43235
Toledo, Ohio, United States, 43617
United States, Rhode Island
Octapharma Site Completed
Pawtucket, Rhode Island, United States, 02860
United States, Tennessee
Octapharma Site Completed
Nashville, Tennessee, United States, 37203
United States, Texas
Octapharma Site Recruiting
Dallas, Texas, United States, 75201
Contact: Michael Eppolito, MBA    201-604-1155   
Octapharma Site Recruiting
Dallas, Texas, United States, 75231
Contact: Michael Eppolito    201-604-1155      
Octapharma Site Completed
Irving, Texas, United States, 75014
Sponsors and Collaborators
Principal Investigator: Wolfgang Frenzel International Medical Monitor, Octapharma AG
  More Information

Responsible Party: Octapharma Identifier: NCT01859754     History of Changes
Other Study ID Numbers: GAM5-28 
Study First Received: May 9, 2013
Last Updated: October 17, 2016
Health Authority: United States: Food and Drug Administration

Keywords provided by Octapharma:
Primary Immune Deficiency Syndrome
Primary immunodeficiency Disease (PIDD)

Additional relevant MeSH terms:
Immunologic Deficiency Syndromes
Immune System Diseases
Immunoglobulins, Intravenous
Rho(D) Immune Globulin
Immunologic Factors
Physiological Effects of Drugs processed this record on October 21, 2016