Primary Immunodeficiencies (PID)
Conditions
Brief summary
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
Subcutaneous immune globulin (SCIG 20%) and facilitated subcutaneous immunoglobulin (fSCIG) treatment in Polish paediatric patients with primary immunodeficiencies (PID) - retrospective medical chart review study
Interventions
None listed
Sponsors
Shire
Study design
Observational model
OTHER
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
No minimum to 18 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | From start of the study upto end of the study (6 months) | Method of administration in participants will be through pump or rapid push. |
| Length of Needle | From start of the study upto end of the study (6 months) | Length of needle used for infusions will be assessed. |
| Assessment of Person who Perform the Infusion | From start of the study upto end of the study (6 months) | Assessment of person (parent/guardian or self) who performs the infusion will be assessed. |
| Type of Pump | From start of the study upto end of the study (6 months) | — |
| Total Dose per 4 weeks | From start of the study upto end of the study (6 months) | Total dose administered per 4 weeks data will be assessed. |
| 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) | — |
Countries
Poland
Outcome results
None listed