Clinical Trials in Japan / NCT06565078
Recruiting
Observational
A Database Survey to Evaluate the Safety of Immune Globulin Subcutaneous (Human), 20% Solution in Participants With Primary Immunodeficiency
NCT06565078 · tracked via the Priya Life Science Japan tracker
Condition(s) studied
Primary Immunodeficiency Diseases (PID)
Investigational drug(s) / intervention(s)
Immune Globulin Subcutaneous (Human), 20% Solution: CUVITRU 20% Solution
Study 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.
Eligibility
Inclusion Criteria:
1. Patients with primary immunodeficiency (PID) enrolled in the PID patient registry.
2. Participant for whom study drug is entered in the therapeutic drug field on the data set.
3. Participant who is entered the intractable disease diagnosis corresponding to PID in the intractable disease information field.
4. Participant for whom the presence or absence of adverse events has been entered in the column of adverse events.
Exclusion Criteria:
1. 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.
2. Participant who is not entered the intractable disease diagnosis corresponding to PID in the intractable disease information field.
3. Participant for whom the presence or absence of adverse events has not been entered in the column of adverse events.
Primary outcome measure(s)
- Number of Participants Who Experience Anaphylactic Reaction as an Adverse Event (AE) — 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)
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. - Number of Participants Who Experience Thromboembolism as an AE — 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)
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. - Number of Participants Who Experience Aseptic Meningitis as an AE — 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)
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.
Trial sites (1)
| Facility | City | Region | Status |
|---|---|---|---|
| Takeda selected site | Tokyo | Tokyo | Recruiting |
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Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06565078 on ClinicalTrials.gov ↗ ← All trials in Japan