Primary Immunodeficiency Diseases (PID)NCT06565078
A Database Survey to Evaluate the Safety of Immune Globulin Subcutaneous (Human), 20% Solution in Participants With Primary Immunodeficiency
An observational study of Primary Immunodeficiency Diseases (PID), run by Takeda at 1 site in Japan.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Primary Immunodeficiency Diseases (PID)
- What is being tested?
- Immune Globulin Subcutaneous (Human), 20% Solution
- Type of treatment
- Injection or infusion
- How many people
- 100 participants
- Where
- 1 siteJapan
- Study dates
- 17 Feb 2025to 31 Mar 2030
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: The population of this survey are all participants who meet the inclusion/exclusion criteria.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Study Director contact
About this study
Official 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
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.
- Conditions
- Primary Immunodeficiency Diseases (PID)
- Being tested
- Immune Globulin Subcutaneous (Human), 20% Solution
- Keywords
- Primary immunodeficiency disease
- Medical subject headings
- Primary Immunodeficiency Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Immune Globulin Subcutaneous (Human), 20% SolutionDrug
CUVITRU 20% Solution
| Study group | Role | What they receive |
|---|---|---|
| Immune Globulin Subcutaneous (Human), 20% Solution | Participants with primary immunodeficiency disease who received Immune Globulin Subcutaneous (Human) 20% infusion in accordance with package insert. Receives: Drug: Immune Globulin Subcutaneous (Human), 20% Solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Who Experience Anaphylactic Reaction as an Adverse Event (AE)
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2024
- Study start17 Feb 2025
- Primary completion31 Mar 2030 (estimated)
- Study completion31 Mar 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary Immunodeficiency Diseases (PID)Studies of the same condition, open and under way.
- More trials run by TakedaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Takeda
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06565078
- Sponsor's protocol ID
- SHP664-403
- Other IDs
- jRCT2031240293
- Status last verified
- Aug 2026
- First submitted
- 20 Aug 2024
- Last updated
- 7 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.