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

Takeda100 enrolled

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.

Study Type

OBSERVATIONAL

Enrollment

100

Conditions

Primary Immunodeficiency Diseases (PID)

Interventions

Immune Globulin Subcutaneous (Human), 20% SolutionDRUG

CUVITRU 20% Solution

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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.

Locations (1)

Takeda selected site

Tokyo, Tokyo, Japan

RECRUITING

Outcomes

Primary Outcomes

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

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.

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)

Central Contacts

Takeda Contact

CONTACT

+1-877-825-3327 medinfoUS@takeda.com

Study Director

CONTACT

Data from ClinicalTrials.gov

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