Actively Recruiting
Study of BP-SCIG 20% in Patients With Primary Immunodeficiency (PID)
Led by Biopharma Plasma LLC · Updated on 2026-01-16
56
Participants Needed
12
Research Sites
132 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Study of BP-SCIG 20% in Patients With Primary Immunodeficiency (PID)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent from patient or legal representative
- Children aged 0 to 18 years of any sex or adult males and females older than 18 years
- Documented diagnosis of primary immunodeficiency with impaired antibody production requiring immunoglobulin replacement therapy
- Body weight of at least 9.1 kg
- Received intravenous immunoglobulin (IVIG) at 0.4-0.8 g/kg every 21 to 28 days for at least 4 months with serum IgG levels ≥5 g/L based on at least two measurements before IVIG administration; or received subcutaneous immunoglobulin (SCIG) at 0.4-0.8 g/kg per month for at least 4 months with serum IgG levels ≥5 g/L based on at least two measurements before SCIG administration; or newly diagnosed PID patients not previously treated with IgG therapy and serum IgG ≤4 g/L
- No serious bacterial infections or hospitalizations for at least 3 months before study start and during screening
- Negative pregnancy test for females of childbearing potential and agreement to use reliable contraception during the study
- Ability to comply with study protocol requirements as judged by the Investigator
You will not qualify if you...
- Withdrawal of consent by patient or legal representative at any time
- Development of serious or unexpected adverse events requiring stopping the study drug
- Receiving blood or blood component transfusions other than the study drug
- Use of prohibited medications during the study
- Repeated non-compliance with treatment or study procedures
- Exclusion based on screening results, including serious bacterial infections or hospitalizations during screening
- Receiving BP-SCIG 20% for less than 4 months
- Presence of serious bacterial infections at the time of pharmacokinetic evaluation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 12 locations
1
Municipal Non-Profit Enterprise "Cherkasy Regional Children's Hospital" of the Cherkasy Regional Council
Cherkasy, Ukraine
Not Yet Recruiting
2
Regional Municipal Non-Profit Enterprise "Chernivtsi Regional Teaching Hospital"
Chernivtsi, Ukraine, 58001
Actively Recruiting
3
Municipal Non-Profit Enterprise "Ivano-Frankivsk Regional Teaching Hospital" of the Ivano-Frankivsk Regional Council
Ivano-Frankivsk, Ukraine, 76008
Actively Recruiting
4
Municipal Non-Profit Enterprise "Ivano-Frankivsk Regional Children's Teaching Hospital" of the Ivano-Frankivsk Regional Council
Ivano-Frankivsk, Ukraine
Not Yet Recruiting
5
Municipal Non-Profit Enterprise "Kyiv City Children's Teaching Hospital No. 1"
Kyiv, Ukraine, 04209
Not Yet Recruiting
6
LLC "Allergy and Cough Clinic"
Lutsk, Ukraine, 43000
Actively Recruiting
7
Municipal Enterprise "Volyn Regional Territorial Medical Association for the Protection of Motherhood and Childhood" of the Volyn Regional Council
Lutsk, Ukraine
Not Yet Recruiting
8
Municipal Non-Profit Enterprise of the Lviv Regional Council "Lviv Regional Teaching Diagnostic Centre"
Lviv, Ukraine, 79010
Actively Recruiting
9
Municipal Non-Profit Enterprise of the Lviv Regional Council "Clinical Centre of Children's Medicine", structural unit "West Ukrainian Specialised Centre"
Lviv, Ukraine, 79035
Not Yet Recruiting
10
Municipal Non-Profit Enterprise "Central Municipal Hospital" of Rivne City Council
Rivne, Ukraine, 33017
Actively Recruiting
11
Municipal Non-Profit Enterprise "Vinnytsia Regional Teaching Hospital named after M.I. Pyrohov" of the Vinnytsia Regional Council
Vinnytsia, Ukraine, 21018
Not Yet Recruiting
12
Municipal Non-Profit Enterprise "Vinnytsia Regional Children's Teaching Hospital" of the Vinnytsia Regional Council
Vinnytsia, Ukraine
Not Yet Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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