Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2026-03-26 @ 3:14 PM
Ignite Modification Date:
2026-03-26 @ 3:14 PM
NCT ID:
NCT07346859
Eligibility Criteria:
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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
0 Years
Study:
NCT07346859
Study Brief:
Protocol Section:
NCT07346859