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)

IDENTIFIERS

Trial Protocol: PID-4001

Clinicaltrials.gov: NCT04636502

PURPOSE

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.

Recruiting

Trial at a glance

What medical condition is being studied? Primary Immunodeficiencies (PID)

How many participants are being enrolled? 150

When is the trial being conducted? Feb 2021 - Jul 2021

How long is participation in the trial? Data collection from the participants’ medical charts will last for 3 months after study initiation.

Key requirements

Sex

All

Age

Up to 18 Years

Accepts Healthy Volunteers?

Trial Details / Participation Requirements

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Trial Type: Observational

Trial Arms/Groups or Cohorts:

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

Primary Outcome Measure(s):

Number of Doses per Infusion [Time Frame: From start of the study upto end of the study (6 months)]

Number of Infusion Sites [Time Frame: From start of the study upto end of the study (6 months)]

Infusion Volume [Time Frame: From start of the study upto end of the study (6 months)]

Method of Administration [Time Frame: From start of the study upto end of the study (6 months)]

Length of Needle [Time Frame: From start of the study upto end of the study (6 months)]

Assessment of Person who Perform the Infusion [Time Frame: From start of the study upto end of the study (6 months)]

Type of Pump [Time Frame: From start of the study upto end of the study (6 months)]

Total Dose per 4 weeks [Time Frame: From start of the study upto end of the study (6 months)]

Total Infusion Volume per 4 Weeks [Time Frame: From start of the study upto end of the study (6 months)]

Treatment Interval per 4 Weeks [Time Frame: From start of the study upto end of the study (6 months)]

Entry Criteria:

- Must be male or female with primary immunodeficiency (PID), aged less than 18 years and treated with Subcutaneous immune globulin (SCIG 20%) and facilitated subcutaneous immunoglobulin (fSCIG) - Must have been treated with SCIG 20% from 1 November 2017 until 30 June 2020 or fSCIG from 1 July 2018 until 30 June 2020. - Must have provided written informed consent and any required privacy authorization (or legally acceptable representative, when applicable) prior to the initiation of any study procedures.

Trial Locations

RESULTS

Uniwersyteckie Centrum Kliniczne

Dębinki 7, 80-952 Gdańsk, Poland

Recruiting

4,097 miles (6,593 km) awayfrom
New York City, New York

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Instytut "Pomnik - Centrum Zdrowia Dziecka"

aleja Dzieci Polskich 20, 04-730 Warszawa, Poland

Recruiting

4,263 miles (6,860 km) awayfrom
New York City, New York

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Uniwersytecki Szpital Dziecięcy w Krakowie

Wielicka 265, 30-663 Kraków, Poland

Will be Recruiting

4,297 miles (6,915 km) awayfrom
New York City, New York

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Wojewódzki Szpital Specjalistyczny im. J. Gromkowskiego

Koszarowa 5, 51-149 Wrocław, Poland

Will be Recruiting

4,146 miles (6,673 km) awayfrom
New York City, New York

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

3-go Maja 13-15, 41-800 Zabrze, Poland

Will be Recruiting

4,241 miles (6,824 km) awayfrom
New York City, New York

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Trial Protocol ID: PID-4001

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