A Database Survey to Evaluate the Safety of Immune Globulin Subcutaneous (Human), 20% Solution in Participants With Primary Immunodeficiency
Post-marketing Database Survey: A Cohort Study to Evaluate the Safety of Cuvitru in Patients With Primary Immunodeficiency Using the PIDJ2 (Primary Immunodeficiency Database in Japan) Registry
2 other identifiers
observational
100
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Feb 2025
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 20, 2024
CompletedFirst Posted
Study publicly available on registry
August 21, 2024
CompletedStudy Start
First participant enrolled
February 17, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 31, 2030
ExpectedStudy Completion
Last participant's last visit for all outcomes
July 31, 2030
February 20, 2026
February 1, 2026
5.5 years
August 20, 2024
February 18, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
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.
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.
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.
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)
Study Arms (1)
Immune Globulin Subcutaneous (Human), 20% Solution
Participants with primary immunodeficiency disease who received Immune Globulin Subcutaneous (Human) 20% infusion in accordance with package insert.
Interventions
CUVITRU 20% Solution
Eligibility Criteria
The population of this survey are all participants who meet the inclusion/exclusion criteria.
You may qualify if:
- Patients with primary immunodeficiency (PID) enrolled in the PID patient registry.
- Participant for whom study drug is entered in the therapeutic drug field on the data set.
- Participant who is entered the intractable disease diagnosis corresponding to PID in the intractable disease information field.
- Participant for whom the presence or absence of adverse events has been entered in the column of adverse events.
You may not qualify if:
- Participant for whom study drug has not been entered in the drug name in the medical history field during the period from January 24, 2024 to January 23, 2029.
- Participant who is not entered the intractable disease diagnosis corresponding to PID in the intractable disease information field.
- Participant for whom the presence or absence of adverse events has not been entered in the column of adverse events.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Takedalead
Study Sites (1)
Takeda selected site
Tokyo, Tokyo, Japan
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Director
CONTACT
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 20, 2024
First Posted
August 21, 2024
Study Start
February 17, 2025
Primary Completion (Estimated)
July 31, 2030
Study Completion (Estimated)
July 31, 2030
Last Updated
February 20, 2026
Record last verified: 2026-02
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR
- Access Criteria
- IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.
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.