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

NCT07346859 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 56

Last updated 2026-01-16

No results posted yet for this study

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.

Conditions

  • Primary Immunodeficiency Diseases

Interventions

DRUG

BP-SCIG 20%

Human normal immunoglobulin 200 mg/mL (including immunoglobulin G (IgG) no less than 95 %) administered subcutaneously. Distribution of immunoglobulin G subclasses in the product: IgG1: 65.6 %, IgG2: 22.1 %, IgG3:10.8 %, IgG4:1.5 % The maximum content of immunoglobulin A is 100 µg/mL.

Sponsors & Collaborators

  • Biopharma Plasma LLC

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
0 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-12-17
Primary Completion
2028-04-17
Completion
2028-07-01

Countries

  • Ukraine

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07346859 on ClinicalTrials.gov