RecruitingNCT06565078

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

Sponsor

Takeda

Enrollment

100 participants

Start Date

Feb 17, 2025

Study Type

OBSERVATIONAL

Conditions

Primary Immunodeficiency Diseases (PID)

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 Criteria4

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 Criteria3

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.

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