A Study of Immune Globulin Subcutaneous (Human), 20% Solution (IGSC, 20%) in Japanese Participants With Primary Immunodeficiency Diseases (PID)
Summary
In this study, Japanese participants with primary immunodeficiency diseases were treated with Immune Globulin Subcutaneous (Human), 20% solution, (IGSC, 20%). This study will be in 3 parts: Part 1: Infusions with Immunoglobulin Intravenous (IGIV) every 3 or 4 weeks for 13 weeks. Part 2: Participants will switch to weekly subcutaneous infusions with IGSC, 20% for 24 weeks. Part 3: A subset will receive biweekly subcutaneous infusions with IGSC, 20% for 12 weeks. The main aim of the study is to assess base levels of Immunoglobulin globulin G (IgG) levels in the blood of the participants after weekly and biweekly treatment with IGSC, 20% (in Parts 2 and 3 of the study). Their PID will be treated by their doctor according to their doctor's usual clinical practice.
Timeline
- Start
- 2020-08-11
- Primary completion
- 2021-12-22
- Completion
- 2021-12-22
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Immune Globulin Intravenous (Human) | Protein / enzyme biologic | 50 mg/kg | Subcutaneous |
| Subject | Immune Globulin Intravenous (Human) | Protein / enzyme biologic | 100 mg/kg | Subcutaneous |
| Subject | Immune Globulin Intravenous (Human) | Protein / enzyme biologic | 200 mg/kg | Subcutaneous |
| Subject | Immune Globulin Intravenous (Human) | Protein / enzyme biologic | 400 mg/kg | Subcutaneous |
| Subject | Immune Globulin Intravenous (Human) | Protein / enzyme biologic | 200 mg/kg | Intravenous |
| Subject | Immune Globulin Intravenous (Human) | Protein / enzyme biologic | 600 mg/kg | Intravenous |