Clinical trial NCT04636502: 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)
Official title: Subcutaneous Immune Globulin (SCIG 20%) and Facilitated Subcutaneous Immunoglobulin (fSCIG) Treatment in Polish Paediatric Patients With Primary Immunodeficiencies (PID) - Retrospective Medical Chart Review Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Primary Immunodeficiencies (PID)
Lead sponsor: Takeda
Sponsor class: INDUSTRY
First posted: 2020-11-19
Enrollment: 96
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants with PID on treatment with SCIG 20% or fSCIG will be included in this study.

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

Eligibility criteria: 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

Primary outcomes:
measure: Number of Doses per Infusion
timeFrame: From start of the study upto end of the study (6 months)
measure: Number of Infusion Sites
timeFrame: From start of the study upto end of the study (6 months)
measure: Infusion Volume
timeFrame: From start of the study upto end of the study (6 months)
measure: Method of Administration
timeFrame: From start of the study upto end of the study (6 months)
measure: Length of Needle
timeFrame: From start of the study upto end of the study (6 months)
measure: Assessment of Person who Perform the Infusion
timeFrame: From start of the study upto end of the study (6 months)
measure: Type of Pump
timeFrame: From start of the study upto end of the study (6 months)
measure: Total Dose per 4 weeks
timeFrame: From start of the study upto end of the study (6 months)
measure: Total Infusion Volume per 4 Weeks
timeFrame: From start of the study upto end of the study (6 months)
measure: Treatment Interval per 4 Weeks
timeFrame: From start of the study upto end of the study (6 months)
Secondary outcomes:
Other outcomes:
Locations:
city: Gdańsk
country: Poland
facility: Uniwersyteckie Centrum Kliniczne
city: Kraków
country: Poland
facility: Uniwersytecki Szpital Dziecięcy w Krakowie
city: Warszawa
country: Poland
facility: Instytut "Pomnik - Centrum Zdrowia Dziecka"
city: Wrocław
country: Poland
facility: Wojewódzki Szpital Specjalistyczny im. J. Gromkowskiego
city: Zabrze
country: Poland
facility: Samodzielny Publiczny Szpital Kliniczny Nr 1 im. prof. Stanisława Szyszko Śląskiego Uniwersytetu Medycznego w Katowicach
Study officials:
affiliation: Shire
name: Study Director
role: STUDY_DIRECTOR
References: