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)

Completed

• Conditions: Primary Immunodeficiencies (PID)

• Registration Number: NCT04636502
• Lead Sponsor: Shire

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

Study Timeline

• Study First Submitted: 2020-11-18
• Study First Submitted QC: 2020-11-18
• Study First Posted: 2020-11-19
• Study Start: 2021-02-08
• Primary Completion: 2021-09-14
• Study Completion: 2021-09-14
• Status Verified: 2021-11
• Last Update Submitted: 2021-11-15
• Last Update Posted: 2021-11-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 96

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.
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.
Type of Pump	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)
Total Infusion Volume per 4 Weeks	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.

Trial Locations

Locations (5)

Uniwersytecki Szpital Dziecięcy w Krakowie; 🇵🇱 Kraków, Poland

Uniwersyteckie Centrum Kliniczne; 🇵🇱 Gdańsk, Poland

Instytut "Pomnik - Centrum Zdrowia Dziecka"; 🇵🇱 Warszawa, Poland

Samodzielny Publiczny Szpital Kliniczny Nr 1 im. prof. Stanisława Szyszko Śląskiego Uniwersytetu Medycznego w Katowicach; 🇵🇱 Zabrze, Poland

Wojewódzki Szpital Specjalistyczny im. J. Gromkowskiego; 🇵🇱 Wrocław, Poland