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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)

NCT ID: NCT04636502

Last Updated: 2021-11-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

96 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-02-08

Study Completion Date

2021-09-14

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

Conditions

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Primary Immunodeficiencies (PID)

Study Design

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Observational Model Type

OTHER

Study Time Perspective

RETROSPECTIVE

Study Groups

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Cohort

Participants who had treated with fSCIG (HyQvia) for not more than 27 months and SCIG 20% (Cuvitru) for not more than 35 months.

No interventions assigned to this group

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
Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shire

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Study Director

Role: STUDY_DIRECTOR

Shire

Locations

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Uniwersyteckie Centrum Kliniczne

Gdansk, , Poland

Site Status

Uniwersytecki Szpital Dziecięcy w Krakowie

Krakow, , Poland

Site Status

Instytut "Pomnik - Centrum Zdrowia Dziecka"

Warsaw, , Poland

Site Status

Wojewódzki Szpital Specjalistyczny im. J. Gromkowskiego

Wroclaw, , Poland

Site Status

Samodzielny Publiczny Szpital Kliniczny Nr 1 im. prof. Stanisława Szyszko Śląskiego Uniwersytetu Medycznego w Katowicach

Zabrze, , Poland

Site Status

Countries

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Poland

References

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Mach-Tomalska M, Pituch-Noworolska A, Bien E, Malanowska M, Machura E, Pukas-Bochenek A, Chrobak E, Pac M, Pietrucha B, Drygala S, Kamieniak M, Kasprzak J, Heropolitanska-Pliszka E. Facilitated subcutaneous immunoglobulin treatment patterns in pediatric patients with primary immunodeficiency diseases. Immunotherapy. 2024 Apr;16(6):391-403. doi: 10.2217/imt-2023-0305. Epub 2024 Feb 16.

Reference Type DERIVED
PMID: 38362629 (View on PubMed)

Heropolitanska-Pliszka E, Pac M, Pietrucha B, Machura E, Pukas-Bochenek A, Chrobak E, Bien E, Malanowska M, Pituch-Noworolska A, Drygala S, Kamieniak M, Kasprzak J, Mach-Tomalska M. Subcutaneous immunoglobulin 20% (Ig20Gly) treatment regimens in pediatric patients with primary immunodeficiencies - real-world data from the IG TATRY study. Expert Rev Clin Immunol. 2023 Jul-Dec;19(10):1281-1291. doi: 10.1080/1744666X.2023.2240514. Epub 2023 Jul 25.

Reference Type DERIVED
PMID: 37489744 (View on PubMed)

Related Links

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https://clinicaltrials.takeda.com/study-detail/5fb63601d98d000029649dce

To obtain more information on the study, click here/on this link

Other Identifiers

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PID-4001

Identifier Type: -

Identifier Source: org_study_id