Recruiting NCT06565078

A Database Survey to Evaluate the Safety of Immune Globulin Subcutaneous (Human), 20% Solution in Participants With Primary Immunodeficiency

— Observational Primary Immunodeficiency Diseases (PID)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied: The protocol lists: Immune Globulin Subcutaneous (Human), 20% Solution.
Who it may be relevant to: Registry conditions: Primary Immunodeficiency Diseases (PID). Basic parameters: No limits · All.
What needs checking: Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place: Japan
Next step: Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

Interventions

Drug Immune Globulin Subcutaneous (Human), 20% Solution
CUVITRU 20% Solution

Primary outcome measures

Number of Participants Who Experience Anaphylactic Reaction as an Adverse Event (AE) [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 [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 [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)]

Eligibility criteria

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.
Participant for whom the presence or absence of adverse events has not been entered in the column of adverse events.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model: Cohort

Study locations

Japan · 1 center

Takeda selected site — Tokyo

Identifiers

NCT: NCT06565078 · SHP664-403 · jRCT2031240293

Primary sources (government registries)

ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗