An observational study in Primary Immunodeficiency Diseases (PID), sponsored by Takeda. Recruiting at 1 site in Japan. Per ClinicalTrials.gov, last updated 2026-08-07.
Sponsored by Takeda · Observational
This study is a retrospective database study in Japan to evaluate the safety of Immune Globulin Subcutaneous (Human), 20% Solution in participants with primary immunodeficiency disease (PID). This survey will conduct in use of medical database called PIDJ2.
199 studies on the registry are indexed under Primary Immunodeficiency Diseases; 46 are open to participants now.
This study's planned enrollment of 100 is below the median of 126 across 73 observational studies indexed under Primary Immunodeficiency Diseases.
Browse Primary Immunodeficiency Diseases studies →Takeda is the lead sponsor of 1,002 studies on the registry; 92 are open to participants now.
Of its 173 completed or terminated interventional studies of FDA-regulated products, 149 (86%) have results posted.
Counted across the registry records on this site, refreshed daily.
The population of this survey are all participants who meet the inclusion/exclusion criteria.
Exclusion Criteria:
Participants with primary immunodeficiency disease who received Immune Globulin Subcutaneous (Human) 20% infusion in accordance with package insert.
Drug: Immune Globulin Subcutaneous (Human), 20% Solution
CUVITRU 20% Solution
Number of Participants Who Experience Anaphylactic Reaction as an Adverse Event (AE)
An AE is defined as any untoward event that occurred in a participant after the first dose of study drug, which does not necessarily have a causal relationship with primary immunodeficiency disease. Number of participants who experience anaphylactic reaction as an AE will be reported.
Time frame: From initial registration in the database or first dose of study drug, whichever came late, up to end date of data period (up to 5 years)
Number of Participants Who Experience Thromboembolism as an AE
An AE is defined as any untoward event that occurred in a participant after the first dose of study drug, which does not necessarily have a causal relationship with primary immunodeficiency disease. Number of participants who experience thromboembolism as an AE will be reported.
Time frame: From initial registration in the database or first dose of study drug, whichever came late, up to end date of data period (up to 5 years)
Number of Participants Who Experience Aseptic Meningitis as an AE
An AE is defined as any untoward event that occurred in a participant after the first dose of study drug, which does not necessarily have a causal relationship with primary immunodeficiency disease. Number of participants who experience aseptic meningitis as an AE will be reported.
Time frame: From initial registration in the database or first dose of study drug, whichever came late, up to end date of data period (up to 5 years)
Plan to share: Yes — Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.
Supporting information: Study protocol, Sap, Icf, Csr
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
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Primary Immunodeficiency Diseases→
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