Retrospective, Observational Chart Review Study Conducted in Poland to Document the Management and Clinical Outcome of CUVITRU and HYQVIA in Pediatric Participants (< 18 Years) With Primary Immunodeficiency (PID)

Study Overview
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Brief Summary
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The purpose of this observational, multi-center, retrospective cohort study is to assess treatment patterns of Cuvitru (SCIG) 20 percent (%) and HyQvia (fSCIG) in polish pediatric participants with PID. The study will collect pediatric patient data. These data are gathered and collected during routine clinical care. As this is a non-interventional/observational study, no treatment/pharmacotherapy is provided as part of the study.

Detailed Description
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Subcutaneous immune globulin (SCIG 20%) and facilitated subcutaneous immunoglobulin (fSCIG) treatment in Polish paediatric patients with primary immunodeficiencies (PID) - retrospective medical chart review study

Official Title
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Subcutaneous Immune Globulin (SCIG 20%) and Facilitated Subcutaneous Immunoglobulin (fSCIG) Treatment in Polish Paediatric Patients With Primary Immunodeficiencies (PID) - Retrospective Medical Chart Review Study

Conditions
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Primary Immunodeficiencies (PID)

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Participant eligibility is determined according to the following criteria prior to entry into the study: The participant or, when applicable, the participant's legally acceptable representative signs and dates a written, informed consent form and any required privacy authorization prior to the initiation of any study procedures. Male or female participants with PID, aged less than (<)18 years treated with SCIG 20% or fSCIG.. Diagnosis of PID according to the criteria developed by the European Society for Immunodeficiencies (ESID) https://esid.org/About-ESID Treatment period for 20% SCIG ranges from November 1, 2017 until June 30, 2020, and for fSCIG from July 1, 2018 until June 30, 2020. Exclusion Criteria: None

Ages Eligible for Study
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Maximum 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 |
| --- | --- |
| Cohort<br>Participants who had treated with fSCIG (HyQvia) for not more than 27 months and SCIG 20% (Cuvitru) for not more than 35 months. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Doses per Infusion |  | From start of the study upto end of the study (6 months) | 
| Number of Infusion Sites |  | From start of the study upto end of the study (6 months) | 
| Infusion Volume |  | From start of the study upto end of the study (6 months) | 
| Method of Administration | Method of administration in participants will be through pump or rapid push. | From start of the study upto end of the study (6 months) | 
| Length of Needle | Length of needle used for infusions will be assessed. | From start of the study upto end of the study (6 months) | 
| Assessment of Person who Perform the Infusion | Assessment of person (parent/guardian or self) who performs the infusion will be assessed. | From start of the study upto end of the study (6 months) | 
| Type of Pump |  | From start of the study upto end of the study (6 months) | 
| Total Dose per 4 weeks | Total dose administered per 4 weeks data will be assessed. | From start of the study upto end of the study (6 months) | 
| Total Infusion Volume per 4 Weeks |  | From start of the study upto end of the study (6 months) | 
| Treatment Interval per 4 Weeks |  | From start of the study upto end of the study (6 months) |