drugset / Trial / NCT04842643
An Extension Study of TAK-664 for Japanese People With Primary Immunodeficiency Disease
Non-randomizedParallel-groupOpen-labelTreatment
Summary
This study is an extension study for participants with primary immunodeficiency disorders who were previously treated with IGSC, 20% in the TAK-664-3001 study. They must have completed that study or be about to complete it before joining this study. Participants will continue treatment with IGCS, 20% in this study. The main aim of this study is to check for side effects from long-term treatment with IGSC, 20% . This medicine is not yet licensed in Japan, so participants will be treated with IGSC, 20% until it becomes commercially available.
Timeline
- Start
- 2021-04-27
- Primary completion
- 2024-04-25
- Completion
- 2024-04-25
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | IGSC | Protein / enzyme biologic | 50 mg/kg | Subcutaneous |
| Subject | IGSC | Protein / enzyme biologic | 100 mg/kg | Subcutaneous |
| Subject | IGSC | Protein / enzyme biologic | 200 mg/kg | Subcutaneous |
| Subject | IGSC | Protein / enzyme biologic | 400 mg/kg | Subcutaneous |