Evaluating the safety of a 20% Immune Globulin solution in patients with primary immunodeficiency

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study conducts a retrospective database survey in Japan to assess the safety of Immune Globulin Subcutaneous (Human), 20% Solution in individuals diagnosed with primary immunodeficiency diseases (PID). Utilizing the PIDJ2 medical database, the study will analyze data from patients enrolled in a PID patient registry, focusing on the presence or absence of adverse events related to the treatment. The study aims to provide insights into the safety profile of this therapeutic intervention over a specified period.

Why it matters

Who can join: the full rules

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.

Where it's running

• Takeda selected site
  Tokyo, Tokyo, Japan Recruiting

Study contacts

• Study coordinator: Takeda Contact
• Email: medinfoUS@takeda.com
• Phone: +1-877-825-3327

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.