Octagam 5% Versus Comparator Post Marketing Trial
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
1 other identifier
observational
623
1 country
27
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started May 2013
Longer than P75 for all trials
27 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 9, 2013
CompletedStudy Start
First participant enrolled
May 21, 2013
CompletedFirst Posted
Study publicly available on registry
May 22, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 22, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
May 22, 2019
CompletedJune 10, 2019
June 1, 2019
6 years
May 9, 2013
June 7, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Incidence Rate of Thromboembolytic events
4 months
Study Arms (2)
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.
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.
Interventions
Any intravenous immunoglobulin marketed product approved for the treatment of PID
Eligibility Criteria
Patients over 18 years old with Primary Immune Deficiency Syndrome PID receiving marketed IVIG as treatment
You may qualify if:
- Male and female patients aged 18 years.
- 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.
- 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.
You may not qualify if:
- Patients with a history of TEEs within the previous 24 months.
- Patients with a regular treatment frequency of more than once every 3 to 4 weeks.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Octapharmalead
Study Sites (27)
Octapharma Research Site
Granada Hills, California, 91344, United States
Octapharma Research Site
Irvine, California, 92697, United States
Octapharma Research Site
Los Angeles, California, 90025, United States
Octapharma Research Site
Redlands, California, 92373, United States
Octapharma Research Site
Centennial, Colorado, 80112, United States
Octapharma Research Site
Roswell, Georgia, 30076, United States
Octapharma Research Site
Chicago, Illinois, 60612, United States
Octapharma Research Site
Springfield, Illinois, 62701, United States
Octapharma Research Site
Fort Wayne, Indiana, 46815, United States
Octapharma Research Site
Wichita, Kansas, 67201, United States
Octapharma Research Site
Fort Mitchell, Kentucky, 41017, United States
Octapharma Research Site
Farmington Hills, Michigan, 48334, United States
Octapharma Research Site
Plymouth, Minnesota, 55446, United States
Octapharma Research Site
Plymouth, Minnesota, 55447, United States
Octapharma Research Site
Omaha, Nebraska, 68124, United States
Octapharma Research Site
East Setauket, New York, 11733, United States
Octapharma Research Site
New York, New York, 10012, United States
Octapharma Research Site
New York, New York, 10065, United States
Octapharma Research Site
Columbus, Ohio, 43235, United States
Octapharma Research Site
Mayfield Heights, Ohio, 44124, United States
Octapharma Research Site
Toledo, Ohio, 43617, United States
Octapharma Research Site
Pawtucket, Rhode Island, 02860, United States
Octapharma Research Site
Anderson, South Carolina, 29621, United States
Octapharma Research Site
Nashville, Tennessee, 37203, United States
Octapharma Research Site
Amarillo, Texas, 79124, United States
Octapharma Research Site
Dallas, Texas, 75231, United States
Octapharma Research Site
Irving, Texas, 75014, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Wolfgang Frenzel
International Medical Monitor, Octapharma AG
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 9, 2013
First Posted
May 22, 2013
Study Start
May 21, 2013
Primary Completion
May 22, 2019
Study Completion
May 22, 2019
Last Updated
June 10, 2019
Record last verified: 2019-06