Actively Recruiting
Post-marketing Database Survey to Evaluate Safety of Cuvitru in Primary Immunodeficiency Using PIDJ2 Registry
Led by Takeda · Updated on 2026-02-20
100
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to evaluate the safety of Immune Globulin Subcutaneous (Human), 20% Solution in people with primary immunodeficiency diseases (PID) using data from a medical database in Japan called PIDJ2. The study is observational and involves reviewing existing patient records to learn about the treatment's safety in this group. It is sponsored by Takeda and focuses on important safety concerns related to this treatment. Participants included in the study are those with PID who have received the Immune Globulin Subcutaneous (Human), 20% Solution according to the treatment guidelines. The study collects data retrospectively from the PIDJ2 registry, which tracks patients over time. The treatment was given as an infusion following the approved package instructions. Participants' medical records will be reviewed to identify any adverse events such as anaphylactic reactions, thromboembolism, or aseptic meningitis occurring from the start of treatment up to five years. This long-term safety monitoring uses the registry data without new treatment or visits. The study period extends through July 2030, focusing on real-world safety outcomes for people with PID receiving this therapy.
CONDITIONS
Brief Title
A Database Survey to Evaluate the Safety of Immune Globulin Subcutaneous (Human), 20% Solution in Participants With Primary Immunodeficiency
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 entered with intractable disease diagnosis corresponding to PID in the intractable disease information field
- Participant with adverse event data recorded in the adverse events field
You will not qualify if you...
- Participant without study drug entry in the medical history field between January 24, 2024 and January 23, 2029
- Participant not entered with intractable disease diagnosis corresponding to PID in the disease information field
- Participant without adverse event data recorded in the adverse events field
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 5 years
Participants who receive Immune Globulin Subcutaneous (Human) 20% infusion are observed for safety outcomes over time using registry data.
Data collected during routine care visits as recorded in the registry
Trial Site Locations
Total: 1 location
1
Takeda selected site
Tokyo, Tokyo, Japan
Actively Recruiting
Research Team
T
Takeda Contact
S
Study Director
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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