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

Takeda

Status: Enrolling

Conditions: Primary Immunodeficiency Diseases (PID)

Treatments: Drug: Immune Globulin Subcutaneous (Human), 20% Solution

Study type: Observational

Funder types: Industry

Identifiers

NCT06565078

jRCT2031240293 (Registry Identifier)

SHP664-403

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

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.

Trial design

100 participants in 1 patient group

Immune Globulin Subcutaneous (Human), 20% Solution

Description:

Participants with primary immunodeficiency disease who received Immune Globulin Subcutaneous (Human) 20% infusion in accordance with package insert.

Treatment:

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