Octagam 5% Versus Comparator Post Marketing Trial

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Primary Immune Deficiency Disorder

Intervention / Treatment
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* Biological: Octagam 5%
* Biological: Other marketed IVIG product


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Octagam 5%<br>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%<br>* Intravenous immunoglobulin 5%<br>|
| Other marketed IVIG product<br>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<br>* Any intravenous immunoglobulin marketed product approved for the treatment of PID<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence Rate of Thromboembolytic events |  | 4 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Primary Immune Deficiency Syndrome, Primary immunodeficiency Disease (PIDD), PID