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NCT Number: NCT06565078

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

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.

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Key information

Conditions

Primary Immunodeficiency Diseases (PID) Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Immune System Diseases Immunologic Deficiency Syndromes Primary Immunodeficiency Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Takeda selected site

Tokyo, Japan

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Immune Globulin Subcutaneous (Human), 20% Solution

Drug

CUVITRU 20% Solution

Primary outcomes

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

    Time frame: 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)

    An AE is defined as any untoward event that occurred in a participant after the first dose of study drug, which does not necessarily have a causal relationship with primary immunodeficiency disease. Number of participants who experience anaphylactic reaction as an AE will be reported.

  2. Number of Participants Who Experience Thromboembolism as an AE

    Time frame: 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)

    An AE is defined as any untoward event that occurred in a participant after the first dose of study drug, which does not necessarily have a causal relationship with primary immunodeficiency disease. Number of participants who experience thromboembolism as an AE will be reported.

  3. Number of Participants Who Experience Aseptic Meningitis as an AE

    Time frame: 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)

    An AE is defined as any untoward event that occurred in a participant after the first dose of study drug, which does not necessarily have a causal relationship with primary immunodeficiency disease. Number of participants who experience aseptic meningitis as an AE will be reported.

Study contacts

Contact information is provided by the study sponsor or research team.

Study Director

CONTACT

Takeda Contact

CONTACT

[email protected]

+1-877-825-3327

Sponsors and collaborators

Lead sponsor

Takeda

Industry

Registry information

Official study title

Post-marketing Database Survey: A Cohort Study to Evaluate the Safety of Cuvitru in Patients With Primary Immunodeficiency Using the PIDJ2 (Primary Immunodeficiency Database in Japan) Registry

Important dates

Study start
2025
Primary completion
2030
Study completion
2030
First posted
Aug 21, 2024
Registry last updated
Feb 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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