drugset / Trial / NCT07346859
Study of BP-SCIG 20% in Patients With Primary Immunodeficiency (PID)
Non-randomizedSingle-groupOpen-labelTreatment
Summary
All patients will receive the investigational medicinal product BP-SCIG 20%, solution for subcutaneous administration, manufactured by BIOPHARMA PLASMA LLC. A loading dose of IMP may be required (at the Investigator's decision): at least 0.2-0.5 g/kg (1.0-2.5 mL/kg) of body weight. This dose is distributed across several days, with a maximum daily dose of 0.1 to 0.15 g/kg. After achieving a steady-state (minimal) level of IgG, maintenance doses are administered at repeated intervals (approximately once a week) to achieve a cumulative monthly dose of 0.4-0.8 g/kg.
Timeline
- Start
- 2025-12-17
- Primary completion
- 2028-04-17
- Completion
- 2028-07-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Immune Globulin Intravenous (Human) | Protein / enzyme biologic | 0.4 g/kg | Subcutaneous |
| Subject | Immune Globulin Intravenous (Human) | Protein / enzyme biologic | 0.8 g/kg | Subcutaneous |