Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
623 participants
OBSERVATIONAL
2013-05-21
2019-05-22
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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.
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.
Other marketed IVIG product
Any intravenous immunoglobulin marketed product approved for the treatment of PID
Interventions
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Octagam 5%
Intravenous immunoglobulin 5%
Other marketed IVIG product
Any intravenous immunoglobulin marketed product approved for the treatment of PID
Eligibility Criteria
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Inclusion Criteria
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
2. Patients with a regular treatment frequency of more than once every 3 to 4 weeks.
18 Years
ALL
No
Sponsors
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Octapharma
INDUSTRY
Responsible Party
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Principal Investigators
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Wolfgang Frenzel
Role: PRINCIPAL_INVESTIGATOR
International Medical Monitor, Octapharma AG
Locations
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Octapharma Research Site
Granada Hills, California, United States
Octapharma Research Site
Irvine, California, United States
Octapharma Research Site
Los Angeles, California, United States
Octapharma Research Site
Redlands, California, United States
Octapharma Research Site
Centennial, Colorado, United States
Octapharma Research Site
Roswell, Georgia, United States
Octapharma Research Site
Chicago, Illinois, United States
Octapharma Research Site
Springfield, Illinois, United States
Octapharma Research Site
Fort Wayne, Indiana, United States
Octapharma Research Site
Wichita, Kansas, United States
Octapharma Research Site
Fort Mitchell, Kentucky, United States
Octapharma Research Site
Farmington Hills, Michigan, United States
Octapharma Research Site
Plymouth, Minnesota, United States
Octapharma Research Site
Plymouth, Minnesota, United States
Octapharma Research Site
Omaha, Nebraska, United States
Octapharma Research Site
East Setauket, New York, United States
Octapharma Research Site
New York, New York, United States
Octapharma Research Site
New York, New York, United States
Octapharma Research Site
Columbus, Ohio, United States
Octapharma Research Site
Mayfield Heights, Ohio, United States
Octapharma Research Site
Toledo, Ohio, United States
Octapharma Research Site
Pawtucket, Rhode Island, United States
Octapharma Research Site
Anderson, South Carolina, United States
Octapharma Research Site
Nashville, Tennessee, United States
Octapharma Research Site
Amarillo, Texas, United States
Octapharma Research Site
Dallas, Texas, United States
Octapharma Research Site
Irving, Texas, United States
Countries
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Other Identifiers
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GAM5-28
Identifier Type: -
Identifier Source: org_study_id
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