Octagam 5% Versus Comparator Post Marketing Trial

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT01859754
Recruitment Status : Recruiting
First Posted : May 22, 2013
Last Update Posted : September 13, 2017
Information provided by (Responsible Party):

Brief 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.

Condition or disease Intervention/treatment
Primary Immune Deficiency Disorder Biological: Octagam 5% Biological: Other marketed IVIG product

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.

Study Type : Observational
Estimated Enrollment : 500 participants
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
Study Start Date : May 2013
Estimated Primary Completion Date : March 2018
Estimated Study Completion Date : March 2018

Group/Cohort Intervention/treatment
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

Primary Outcome Measures :
  1. Incidence Rate of Thromboembolytic events [ Time Frame: 4 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01859754

Contact: Mikaela Grupp 866-337-1868

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Octapharma Research Site Withdrawn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

Responsible Party: Octapharma Identifier: NCT01859754     History of Changes
Other Study ID Numbers: GAM5-28
First Posted: May 22, 2013    Key Record Dates
Last Update Posted: September 13, 2017
Last Verified: September 2017

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