A Database Survey to Evaluate the Safety of Immune Globulin Subcutaneous (Human), 20% Solution in… (NCT06565078) | Clinical Trial Compass
RecruitingNot Applicable
A Database Survey to Evaluate the Safety of Immune Globulin Subcutaneous (Human), 20% Solution in Participants With Primary Immunodeficiency
Japan100 participantsStarted 2025-02-17
Plain-language 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.
Who can participate
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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.
Exclusion criteria
. 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of Participants Who Experience Anaphylactic Reaction as an Adverse Event (AE)
Timeframe: 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)
2
Number of Participants Who Experience Thromboembolism as an AE
Timeframe: 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)
3
Number of Participants Who Experience Aseptic Meningitis as an AE
Timeframe: 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)