Primary Immunodeficiencies (PID) Clinical Trial
— IG-TATRYOfficial 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
| Verified date | November 2021 |
| Source | Takeda |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
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.
| Status | Completed |
| Enrollment | 96 |
| Est. completion date | September 14, 2021 |
| Est. primary completion date | September 14, 2021 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | N/A to 18 Years |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| Poland | Uniwersyteckie Centrum Kliniczne | Gdansk | |
| Poland | Uniwersytecki Szpital Dzieciecy w Krakowie | Kraków | |
| Poland | Instytut "Pomnik - Centrum Zdrowia Dziecka" | Warszawa | |
| Poland | Wojewódzki Szpital Specjalistyczny im. J. Gromkowskiego | Wroclaw | |
| Poland | Samodzielny Publiczny Szpital Kliniczny Nr 1 im. prof. Stanislawa Szyszko Slaskiego Uniwersytetu Medycznego w Katowicach | Zabrze |
| Lead Sponsor | Collaborator |
|---|---|
| Shire |
Poland,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Number of Doses per Infusion | From start of the study upto end of the study (6 months) | ||
| Primary | Number of Infusion Sites | From start of the study upto end of the study (6 months) | ||
| Primary | Infusion Volume | From start of the study upto end of the study (6 months) | ||
| Primary | Method of Administration | Method of administration in participants will be through pump or rapid push. | From start of the study upto end of the study (6 months) | |
| Primary | Length of Needle | Length of needle used for infusions will be assessed. | From start of the study upto end of the study (6 months) | |
| Primary | Assessment of Person who Perform the Infusion | Assessment of person (parent/guardian or self) who performs the infusion will be assessed. | From start of the study upto end of the study (6 months) | |
| Primary | Type of Pump | From start of the study upto end of the study (6 months) | ||
| Primary | Total Dose per 4 weeks | Total dose administered per 4 weeks data will be assessed. | From start of the study upto end of the study (6 months) | |
| Primary | Total Infusion Volume per 4 Weeks | From start of the study upto end of the study (6 months) | ||
| Primary | Treatment Interval per 4 Weeks | From start of the study upto end of the study (6 months) |