Non-Interventional Post-Marketing Safety Study on the Long-Term Safety of HYQVIA (Global)

Study Overview
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Brief Summary
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The purpose of the proposed study is to acquire additional data (including the assessment of anti-rHuPH20 antibodies) on the long-term safety of HYQVIA and to assess the prescribed treatment regimens and treatment administration in routine clinical practice.

Official Title
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Non-Interventional Post-Marketing Safety Study on the Long-Term Safety of HYQVIA (Global)

Conditions
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Primary Immunodeficiency Diseases (PID)

Intervention / Treatment
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* Biological: HYQVIA


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Participant requires immunoglobulin treatment for primary immunodeficiency disease (PIDD) Participant age is compatible with local package insert requirements Participant has been prescribed or has started treatment with HYQVIA (Immune Globulin (Human) 10% with rHuPH20) Participant is willing and able to comply with the requirements of the protocol. Female participant of child-bearing potential agrees to inform the investigator if she becomes pregnant, or plans to become pregnant during the course of the study Exclusion Criteria: Participant has known hypersensitivity to any of the components of the medicinal product Participant has participated in an interventional clinical study involving a medicinal product or device within 30 days prior to enrollment or is scheduled to participate in an interventional clinical study involving a medical product or device during the course of this study Participant is a family member or employee of the investigator Participant is planning to become pregnant, pregnant or breastfeeding at the time of enrollment

Ages Eligible for Study
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Minimum Age: 16 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 |
| --- | --- |
| HYQVIA- Epoch 1<br>Participants receiving HYQVIA | Biological: HYQVIA<br>* Immune Globulin Infusion 10% (Human) with Recombinant Human Hyaluronidase<br>|
| HYQVIA- Epoch 2<br>Participants with rHuPH antibody titers ≥160 (tested in Epoch 1) | Biological: HYQVIA<br>* Immune Globulin Infusion 10% (Human) with Recombinant Human Hyaluronidase<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of all related serious adverse events (SAEs) |  | Throughout the study period of approximately 5 1/2 years | 
| Incidence of all SAEs |  | Throughout the study period of approximately 5 1/2 years | 
| Incidence of non-serious adverse events (AEs), related and not related, local and systemic. |  | Throughout the study period of approximately 5 1/2 years | 
| Incidence of Infections |  | Throughout the study period of approximately 5 1/2 years | 
| Incidence and titer of binding and neutralizing antibodies to rHuPH20 |  | Throughout the study period of approximately 5 1/2 years | 
| Treatment Regimen: Total dose administered |  | Throughout the study period of approximately 5 1/2 years | 
| Treatment Regimen: Infusion interval |  | Throughout the study period of approximately 5 1/2 years | 
| Treatment Administration: Actual volume per infusion |  | Throughout the study period of approximately 5 1/2 years | 
| Treatment Administration: Maximum infusion rate |  | Throughout the study period of approximately 5 1/2 years | 
| Treatment Administration: Mean rate of infusion |  | Throughout the study period of approximately 5 1/2 years | 
| Treatment Administration: Duration of infusion |  | Throughout the study period of approximately 5 1/2 years | 
| Treatment Administration: Number of infusion sites per infusion |  | Throughout the study period of approximately 5 1/2 years | 
| Health Related Quality of Life: Short Form-36 (SF-36) |  | Every 3 months in first year of study, annually for remainder of study | 
| Health Related Quality of Life: EuroQol 5-Dimension (EQ-5D) Questionnaire |  | Every 3 months in first year of study, annually for remainder of study | 
| Health Related Quality of Life: Treatment Satisfaction Questionnaire for Medication-9 (TSQM-9) |  | Every 3 months in first year of study, annually for remainder of study | 
| Health Related Quality of Life: Treatment Preference Questionnaire |  | Annually throughout the study | 
| Health resource use: hospitalizations |  | Throughout the study period of approximately 5 1/2 years | 
| Health resource use: length of hospital stay |  | Throughout the study period of approximately 5 1/2 years | 
| Health resource use: acute care visits |  | Throughout the study period of approximately 5 1/2 years | 
| Health resource use: Emergency Room visits |  | Throughout the study period of approximately 5 1/2 years | 
| Days missed from work/school |  | Throughout the study period of approximately 5 1/2 years |