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NCT Number: 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)

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.

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Key information

Conditions

Primary Immunodeficiencies (PID)

Age range

Up to 18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Uniwersyteckie Centrum Kliniczne, Gdansk, Poland

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Number of Doses per Infusion

    Time frame: From start of the study upto end of the study (6 months)

  2. Number of Infusion Sites

    Time frame: From start of the study upto end of the study (6 months)

  3. Infusion Volume

    Time frame: From start of the study upto end of the study (6 months)

  4. Method of Administration

    Time frame: From start of the study upto end of the study (6 months)

    Method of administration in participants will be through pump or rapid push.

  5. Length of Needle

    Time frame: From start of the study upto end of the study (6 months)

    Length of needle used for infusions will be assessed.

  6. Assessment of Person who Perform the Infusion

    Time frame: 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.

  7. Type of Pump

    Time frame: From start of the study upto end of the study (6 months)

  8. Total Dose per 4 weeks

    Time frame: From start of the study upto end of the study (6 months)

    Total dose administered per 4 weeks data will be assessed.

  9. Total Infusion Volume per 4 Weeks

    Time frame: From start of the study upto end of the study (6 months)

  10. Treatment Interval per 4 Weeks

    Time frame: From start of the study upto end of the study (6 months)

Sponsors and collaborators

Lead sponsor

Shire

Industry

Registry information

Official study 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

Acronym: IG-TATRY

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Nov 19, 2020
Registry last updated
Nov 17, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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