A Study About Low Blood Pressure in Patients With Primary Immunodeficiency Disease Treated With Immune Globulin Products

Study Overview
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Brief Summary
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This is a safety study to evaluate the risk of low blood pressure in subjects with Primary Immune Deficiency disorder (PID) treated with Bivigam™ or another commercial product under real world conditions. No study medication will be provided to subjects in this study. Study physicians will make all treatment decisions according to their usual practice and will provide prescriptions for his/her subjects, as appropriate. The only addition is the collection and structured documentation of data generated through usual practice.

Official Title
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A Multicenter, Non-interventional, Observational, Prospective Study to Assess Hypotension in Patients With Primary Immunodeficiency Disease Treated With Bivigam™ (Human 10%) or Other Commercial Human 10% Immune Globulin (Intravenous) (IGIV) Products During Infusion and up to 72 Hours Post Infusion

Conditions
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Primary Immune Deficiency Disorder

Intervention / Treatment
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* Biological: Bivigam
* Biological: Other


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with PID diagnosis Current subjects requiring treatment with an IGIV Exclusion Criteria: Patients not meeting inclusion criteria
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 |
| --- | --- |
| Bivigam<br>Patients with primary immunodeficiency disease treated with Bivigam™ | Biological: Bivigam<br>* Human immune globulin<br>|
| Other IGIV<br>Patients with primary immunodeficiency disease treated with other IGIVs | Biological: Other<br>* Human immune globulin<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of Hypotension | The number of events of hypotension in subjects treated with Bivigam or other immune globulin intravenous (IGIV) products. Hypotension is defined as a systolic decrease of 30mmHG or a systolic blood pressure less than 90mmHG and clinical symptoms of hypotension including 1 or more of the following: dizziness, light-headedness, fainting (syncope), chest pain, or diaphoresis. | During infusion and up to 72 hours post infusion. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of Hepatic Impairment | The number of events of hepatic impairment in subjects treated with Bivigam or other immune globulin intravenous products. The criterion for defining hepatic impairment is transaminases three times the upper limit of normal evaluated based upon medical history, treatment history and the presence of co-morbid conditions. | Throughout the duration of study participation, up to approximately 140 days. | 
| Rate of Renal Impairment | The number of events of renal impairment in subjects treated with Bivigam or other immune globulin intravenous. The criterion for defining hepatic impairment is creatinine values greater than three times the upper limit of normal evaluated based upon medical history, treatment history and the presence of co-morbid conditions. | Throughout the duration of study participation, up to approximately 140 days. | 
| Rates of Other Adverse Events | The rates of other adverse events in patients treated with Bivigam™ or other immune globulin intravenous products. | Throughout the duration of study participation, up to approximately 140 days. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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PID