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

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

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Phase N/A

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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.

Eligibility

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.

Study details
    Primary Immunodeficiency Diseases (PID)

NCT06565078

Takeda

15 September 2025

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A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

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Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

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Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
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