Status:

RECRUITING

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

Lead Sponsor:

Takeda

Conditions:

Primary Immunodeficiency Diseases (PID)

Eligibility:

All Genders

Brief 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 sur...

Eligibility Criteria

Inclusion

  • 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 is 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 been entered in the column of adverse events.

Exclusion

  • 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.
  • 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 column of adverse events.

Key Trial Info

Start Date :

February 17 2025

Trial Type :

OBSERVATIONAL

Allocation :

ESTIMATED

End Date :

July 31 2030

Estimated Enrollment :

100 Patients enrolled

Trial Details

Trial ID

NCT06565078

Start Date

February 17 2025

End Date

July 31 2030

Last Update

February 20 2025

Active Locations (1)

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Page 1 of 1 (1 locations)

1

Takeda selected site

Tokyo, Tokyo, Japan

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