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

Last updated: February 18, 2025
Sponsor: Takeda
Overall Status: Active - Recruiting

Phase

N/A

Condition

Primary Immunodeficiency Disorders

Hiv Infections

Treatment

Immune Globulin Subcutaneous (Human), 20% Solution

Clinical Study ID

NCT06565078
SHP664-403
jRCT2031240293
  • All Genders

Study 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 Criteria

Inclusion

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 dataset.

  3. Participant who is entered the intractable disease diagnosis corresponding to PID inthe intractable disease information field.

  4. Participant for whom the presence or absence of adverse events has been entered inthe column of adverse events.

Exclusion

Exclusion Criteria:

  1. Participant for whom study drug has not been entered in the drug name in the medicalhistory field during the period from January 24, 2024 to January 23, 2029.

  2. Participant who is not entered the intractable disease diagnosis corresponding toPID in the intractable disease information field.

  3. Participant for whom the presence or absence of adverse events has not been enteredin the column of adverse events.

Study Design

Total Participants: 100
Treatment Group(s): 1
Primary Treatment: Immune Globulin Subcutaneous (Human), 20% Solution
Phase:
Study Start date:
February 17, 2025
Estimated Completion Date:
July 31, 2030

Connect with a study center

  • Takeda selected site

    Tokyo,
    Japan

    Active - Recruiting

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