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
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Observational
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.
Eligibility
Participation Requirements
Sex: All
Healthy Volunteers: f
View:
• 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.
Locations
Other Locations
Japan
Takeda selected site
RECRUITING
Tokyo
Contact Information
Primary
Takeda Contact
medinfoUS@takeda.com
+1-877-825-3327
Backup
Study Director
Time Frame
Start Date: 2025-02-17
Estimated Completion Date: 2030-07-31
Participants
Target number of participants: 100
Treatments
Immune Globulin Subcutaneous (Human), 20% Solution
Participants with primary immunodeficiency disease who received Immune Globulin Subcutaneous (Human) 20% infusion in accordance with package insert.
Related Therapeutic Areas
Sponsors
Leads: Takeda