BP-SCIG 20% treatment for primary immunodeficiency

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

The trial enrolls children (≥9.1 kg) and adults with primary immunodeficiency and impaired antibody production who require immunoglobulin replacement and have prior IVIG or SCIG treatment. After a screening period of up to two months, participants may receive a loading dose of BP-SCIG 20% spread over several days, followed by weekly maintenance doses targeting a cumulative monthly dose of 0.4–0.8 g/kg for 52 weeks. The first four administrations are performed in a hospital setting, treatment is organized into 13 cycles, and there is a one-week follow-up after the final cycle. Safety, tolerability, and maintenance of IgG levels will be monitored throughout the treatment period.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* a signed informed written consent of the patient/patient's parents or legally authorised representative to take part in the study;
* 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:

* at the request of the patient/patient's parents/patient's legally authorised representative at any time and for any reason;
* 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.

Where it's running

• Regional Municipal Non-Profit Enterprise "Chernivtsi Regional Teaching Hospital"
  Chernivtsi, Ukraine Recruiting
• Municipal Non-Profit Enterprise "Ivano-Frankivsk Regional Teaching Hospital" of the Ivano-Frankivsk Regional Council
  Ivano-Frankivsk, Ukraine Recruiting
• LLC "Allergy and Cough Clinic"
  Lutsk, Ukraine Recruiting
• Municipal Non-Profit Enterprise of the Lviv Regional Council "Lviv Regional Teaching Diagnostic Centre"
  Lviv, Ukraine Recruiting
• Municipal Non-Profit Enterprise "Central Municipal Hospital" of Rivne City Council
  Rivne, Ukraine Recruiting
• Municipal Non-Profit Enterprise "Cherkasy Regional Children's Hospital" of the Cherkasy Regional Council
  Cherkasy, Ukraine Not yet recruiting

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.