Study of BP-SCIG 20% in Patients With Primary Immunodeficiency (PID)
NCT ID: NCT07346859
Last Updated: 2026-01-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
56 participants
INTERVENTIONAL
2025-12-17
2028-07-01
Brief Summary
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Detailed Description
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screening period: lasting up to 2 months, and involving three screening visits; treatment period (from Cycle 1 visit \[the first 4 administrations of the IMP are to be performed in a hospital setting\] during the 52 weeks to the last visit of Cycle 13).
follow-up period after completion of the last cycle of the treatment period, with a duration of 1 week.
Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Single group receiving BP-SCIG20%
Patients receive BP-SCIG 20% (human normal immunoglobulin, 200 mg/mL, IgG ≥95%) administered subcutaneously. Dosage: 0.4-0.8 g/kg per month, divided into weekly infusions. Duration: Long-term treatment as per study protoco
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* children from 0 to 18 years of age, of both sexes; or adult patients: males and females older than 18 years;
* a diagnosis of primary immunodeficiency with impaired antibody production document-supported according to the ESID criteria, requiring replacement therapy with immunoglobulins;
* patients with a body weight of no less than 9.1 kg;
* patients who received replacement therapy with intravenous immunoglobulin (IVIG) products at intervals from 21 to 28 days at the dose of 0.4-0.8 g/kg, for at least 4 months prior to the start of the study and have total serum IgG levels ≥5 g/L\*, which is confirmed by the results of no less than 2 measurements performed immediately before the scheduled IVIG administration after signing the ICF, or patients who received replacement therapy with subcutaneous immunoglobulin (SCIG) products at the dose of 0.4-0.8 g/kg per month, for at least 4 months prior to the start of the study, and have total serum IgG levels ≥5 g/L\*, based on the results of no less than 2 measurements performed immediately before the scheduled SCIG administration after signing the ICF; or patients with a newly established diagnosis of PID who have not yet received replacement therapy with IgG products (treatment-naïve patients) and have a serum IgG level ≤ 4 g/L;
* absence of episodes of serious bacterial infections (bacteraemia or sepsis, bacterial meningitis, osteomyelitis/septic arthritis, bacterial pneumonia, visceral abscess) while taking the previous medicinal product and absence of episodes of hospitalisation for at least 3 months prior to inclusion in the study and during the screening period (prior to the first administration of the IMP BP-SCIG 20%);
* a negative pregnancy test (in female patients with childbearing potential); readiness to use reliable methods of contraception throughout the study period;
* patient's ability, in the Investigator's judgement, to comply with all the requirements of the study protocol.
Exclusion Criteria
* patient developing serious and/or unexpected AEs/ARs during the study, which require discontinuation of the product;
* blood transfusions or transfusions of blood components and products, with the exception of the IMP;
* the need to use medicinal products disallowed as part of this study;
* systematic lack of patient compliance with the treatment regimen prescribed by the Investigator;
* systematic lack of patient compliance with the procedures specified in this protocol;
* exclusion based on screening results, including emergence of episodes of serious bacterial infections while receiving a previous IV immunoglobulin product and episodes of hospitalisation during the screening period (before the first administration of the IMP BP-SCIG 20%).
* Receiving the IMP BP-SCIG 20% for less than 4 months;
* Presence of episodes of serious bacterial infections (bacteraemia or sepsis, bacterial meningitis, osteomyelitis/septic arthritis, bacterial pneumonia, visceral abscess) at the time of investigation of PK parameters.
0 Years
ALL
No
Sponsors
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Biopharma Plasma LLC
INDUSTRY
Responsible Party
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Locations
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Municipal Non-Profit Enterprise "Cherkasy Regional Children's Hospital" of the Cherkasy Regional Council
Cherkasy, , Ukraine
Regional Municipal Non-Profit Enterprise "Chernivtsi Regional Teaching Hospital"
Chernivtsi, , Ukraine
Municipal Non-Profit Enterprise "Ivano-Frankivsk Regional Teaching Hospital" of the Ivano-Frankivsk Regional Council
Ivano-Frankivsk, , Ukraine
Municipal Non-Profit Enterprise "Ivano-Frankivsk Regional Children's Teaching Hospital" of the Ivano-Frankivsk Regional Council
Ivano-Frankivsk, , Ukraine
Municipal Non-Profit Enterprise "Kyiv City Children's Teaching Hospital No. 1"
Kyiv, , Ukraine
LLC "Allergy and Cough Clinic"
Lutsk, , Ukraine
Municipal Enterprise "Volyn Regional Territorial Medical Association for the Protection of Motherhood and Childhood" of the Volyn Regional Council
Lutsk, , Ukraine
Municipal Non-Profit Enterprise of the Lviv Regional Council "Lviv Regional Teaching Diagnostic Centre"
Lviv, , Ukraine
Municipal Non-Profit Enterprise of the Lviv Regional Council "Clinical Centre of Children's Medicine", structural unit "West Ukrainian Specialised Centre"
Lviv, , Ukraine
Municipal Non-Profit Enterprise "Central Municipal Hospital" of Rivne City Council
Rivne, , Ukraine
Municipal Non-Profit Enterprise "Vinnytsia Regional Teaching Hospital named after M.I. Pyrohov" of the Vinnytsia Regional Council
Vinnytsia, , Ukraine
Municipal Non-Profit Enterprise "Vinnytsia Regional Children's Teaching Hospital" of the Vinnytsia Regional Council
Vinnytsia, , Ukraine
Countries
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Facility Contacts
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Provided Documents
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Document Type: Study Protocol
Other Identifiers
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2024-SCIg-BP
Identifier Type: -
Identifier Source: org_study_id
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