What is this study trying to find out about primary immunodeficiency disease?

This study is observing the safety of Immune Globulin Subcutaneous (Human), 20% Solution in people with primary immunodeficiency disease. It uses existing patient data to identify possible side effects and better understand treatment risks. The research is sponsored by Takeda and relies on a Japanese medical database for its analysis.

Who may be eligible for this primary immunodeficiency disease clinical trial?

Eligibility includes having a diagnosis of primary immunodeficiency disease and being recorded in the PID patient registry with treatment using the study drug. There is no age or gender restriction listed. Please review eligibility criteria for more details.

Is there any cost to participate in this primary immunodeficiency disease clinical trial?

Study-related care, including the use of the study drug and all trial data review, is provided at no cost. However, personal expenses such as travel for routine medical visits may vary and are not guaranteed to be covered.

Actively Recruiting

All Genders

ID06565078

Safety Evaluation of Immune Globulin Subcutaneous Human, 20% Solution in Patients with Primary Immunodeficiency Using a Japanese Patient Registry

Led by Takeda · Updated on 2026-08-07

100

Participants Needed

Research Sites

N/A

Total Duration

AI-Summary

What this Trial Is About

Researchers are evaluating the safety of Immune Globulin Subcutaneous Human, 20% Solution in people with primary immunodeficiency disease PID using a retrospective medical database in Japan called PIDJ2. This observational study collects information about patients who have received this treatment as part of routine care to better understand potential adverse events. The study is sponsored by Takeda and uses existing patient registry data to assess safety outcomes. Participants included in this study are those with PID who have received Immune Globulin Subcutaneous Human 20% infusion following the official package instructions. The study does not administer treatments but analyzes data from the PIDJ2 database collected between January 24, 2024, and January 23, 2029. It focuses on patients whose records include details about use of the study drug and documented adverse events. During the study, researchers will review the database to identify any participants who experienced specific adverse events such as anaphylactic reactions, thromboembolism, or aseptic meningitis up to five years from the initial registration or first dose. The study involves no direct visits or interventions, as it is based on reviewing existing records. The total study period extends until March 31, 2030, allowing long-term safety observations.

CONDITIONS

Brief Title

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

Who Can Participate

All Genders

Eligibility Criteria

You may qualify if you...

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 has 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 adverse events column

You will not qualify if you...

Participant for whom study drug has not been entered in the drug name in the medical history field 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 adverse events column

Research Team

Takeda Contact

Study Director

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