New IVIG aims to slash infection risk for immune-deficient patients

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria 1. Men or women; age between 02 and 60 years; written informed consent/assent. 2. Diagnosis of primary immunodeficiency disease (PID) with decreased antibody production due to common variable immunodeficiency (CVID) or X-linked agammaglobulinemia (XLA). 3. Treatment-naïve patients and those receiving intravenous immunoglobulin replacement therapy at 21- to 28-day intervals, with doses ranging from 300 to 800 mg/kg per infusion. 4. Negative pregnancy test in females of childbearing potential; willingness to use effective contraceptive methods throughout the study. 5. Subjects currently receiving any subcutaneous or intramuscular immunoglobulin may be enrolled by switching to IVIG therapy at the investigator's discretion, considering the potential benefit to the participant. Exclusion Criteria Patients who meet any of the following criteria will be disqualified from participating. 1. Known intolerance or hypersensitivity to immunoglobulins or components of the study drug. 2. Any contraindications to the use of immunoglobulins. 3. Patients with a BMI \< 18.5 or \> 40 kg/m2. 4. Secondary immunodeficiency or clinical conditions that potentially cause secondary immunodeficiency, such as chronic lymphocytic leukemia, lymphoma, multiple myeloma, enteropathies, or nephropathies with protein loss and hypoalbuminemia. 5. Clinically significant changes in safety assessments, defined as: * Blood count * Hb \< 10,5 g/dL * Leukocytes \< 3,000 cells/mm3 or \> 11,000 cells/mm3 * Absolute neutrophil count \< 1,000 cells/mm3 * Coagulation: o PT and aPTT\> 2,5 x ULN. * Biochemistry: * glycated hemoglobin \> 6.5% * total bilirubin and fractions, alkaline phosphatase, ALT, AST, GGT \> 2.5 x ULN * creatinine above 3mg/dL or creatinine clearance \<30mL/min * Urine I: * Clinically significant leukocyturia at the discretion of the investigator. 6. History of serious bacterial infections within three months before screening, presence of an active infection at the time of inclusion, and failure to fully resolve any non-serious infection at least two weeks before screening. 7. Any febrile illness in the 14 days before inclusion. 8. Any active or resolved cancer in the last 12 months before screening. 9. Receiving any blood products (except intravenous immunoglobulins) during the last 3 months before screening. 10. History of thrombotic events (including myocardial infarction, cerebral vascular accident \[including stroke\], pulmonary embolism, and deep vein thrombosis) within the last 6 months before enrollment or the presence of significant risk factors for thrombosis events. 11. Previous use of live attenuated virus vaccines within 3 months before enrollment. 12. Selective immunoglobulin A (IgA) deficiency or the presence of known antibodies against IgA. 13. Pregnancy, unreliable contraceptive methods, or lactation period (women only) 14. Known alcohol or drug abuse. 15. Patients with mental disorders that, in the investigator's opinion, may affect adherence to the protocol. 16. Other primary immunodeficiencies (PIDs) besides CVID or XLA. 17. Inability to comply with protocol activities. 18. Patients who are infected with HIV, HBV, HCV, or syphilis. 19. Any surgery scheduled to occur during the trial period. 20. Patients with cystic fibrosis 21. Patients with poorly controlled epilepsy, migraine, or hypertension (SBP ≥ 160 and/or DBP ≥ 100) managed with medication. 22. Subjects who have finished participation in a clinical trial with another experimental IVIG, less than one year before enrollment, may be included if they have a potential benefit as per CNS Res. 251/1997. 23. Any other medical condition that, in the investigator's opinion, may increase the risk of participation in this study.