Clinical Trial

Study of BP-SCIG 20% in Patients With Primary Immunodeficiency (PID)

Recruiting Phase 3
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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.
Trial Details
NCT Number NCT07346859
Lead Sponsor Biopharma Plasma LLC
Conditions Primary Immunodeficiency Diseases
Enrollment 56 participants
Start Date 2025-12-17
Primary Completion 2028-04-17 (estimated)
Study Completion 2028-07-01 (estimated)
Updated on ClinicalTrials.gov 2026-01-16