RecruitingNot Applicable

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

Japan100 participantsStarted 2025-02-17

Plain-language 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.

Who can participate

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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 criteria

✕. 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.

What they're measuring

Number of Participants Who Experience Anaphylactic Reaction as an Adverse Event (AE)

Timeframe: From initial registration in the database or first dose of study drug, whichever came late, up to end date of data period (up to 5 years)

Number of Participants Who Experience Thromboembolism as an AE

Timeframe: From initial registration in the database or first dose of study drug, whichever came late, up to end date of data period (up to 5 years)

Number of Participants Who Experience Aseptic Meningitis as an AE

Timeframe: From initial registration in the database or first dose of study drug, whichever came late, up to end date of data period (up to 5 years)

Trial details

NCT IDNCT06565078

SponsorTakeda

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2030-07-31

Contact for this trial

Takeda Contact

+1-877-825-3327 medinfoUS@takeda.com

View on ClinicalTrials.gov More Primary Immunodeficiency Diseases (PID) trials

Who can participate

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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 criteria

✕. 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.

What they're measuring

Number of Participants Who Experience Anaphylactic Reaction as an Adverse Event (AE)

Timeframe: From initial registration in the database or first dose of study drug, whichever came late, up to end date of data period (up to 5 years)

Number of Participants Who Experience Thromboembolism as an AE

Timeframe: From initial registration in the database or first dose of study drug, whichever came late, up to end date of data period (up to 5 years)

Number of Participants Who Experience Aseptic Meningitis as an AE

Timeframe: From initial registration in the database or first dose of study drug, whichever came late, up to end date of data period (up to 5 years)