Octagam 5% Versus Comparator Post Marketing Trial
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|ClinicalTrials.gov Identifier: NCT01859754|
Recruitment Status : Recruiting
First Posted : May 22, 2013
Last Update Posted : June 12, 2018
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|
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|
|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 :||May 2019|
|Estimated Study Completion Date :||May 2019|
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
- Incidence Rate of Thromboembolytic events [ Time Frame: 4 months ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01859754
|Contact: Mikaela Gruppemail@example.com|
Show 26 Study Locations
|Principal Investigator:||Wolfgang Frenzel||International Medical Monitor, Octapharma AG|