NCT06565078

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

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
• Phase: —
• Study type: Observational
• Enrollment: 100 (estimated)
• Sponsor: Takeda · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Conditions

• Primary Immunodeficiency Diseases (PID)

Interventions

Type	Name	Description
DRUG	Immune Globulin Subcutaneous (Human), 20% Solution	CUVITRU 20% Solution

Timeline

• Start date: 2025-02-17
• Primary completion: 2030-07-31
• Completion: 2030-07-31
• First posted: 2024-08-21
• Last updated: 2026-02-20

Locations

1 site across 1 country: Japan