Efficacy, Safety, and Pharmacokinetics of Shu Yang IVIG (Imunoforte)

Inclusion Criteria: Written informed consent/assent. Male or female. Ages ≤ 60 years old and ≥ 06 years old. Diagnosis of Primary Immunodeficiency Disease (PID) with a reduction in antibody production due to: a. Common Variable Immunodeficiency (CVID) as per European Immunodeficiency Society (ESID)/Pan American Immunodeficiency Group (PAGID), as defined in section 5.1, OR b. X-linked agammaglobulinemia (XLA) as per ESID/PAGID, as defined in section 5.1. Receiving replacement therapy with intravenous immunoglobulin at 21- to 28-day intervals at 300-600 mg/kg/month for a minimum of 2 months before the start of the study; Absence of episodes of serious bacterial infections with previous use of an IV immunoglobulin for at least 3 months before screening; Negative pregnancy test (in female patients with childbearing potential); readiness to use reliable methods of contraception throughout the study period; Patients who participated in a clinical trial with another experimental IVIG may be enrolled if they have a potential benefit according to Res. CNS 251/1997; Patients currently on treatment with any subcutaneous or intramuscular immunoglobulin may be enrolled switching to IVIG therapy at the investigator's discretion, considering the potential benefit to the patient. Exclusion Criteria: Known intolerance or hypersensitivity to immunoglobulins or components of the test article; Any contraindications to the use of immunoglobulins; Secondary immunodeficiency or conditions potentially causing secondary immunodeficiency such as chronic lymphoid leukemia, lymphoma, multiple myeloma, protein-losing enteropathies or nephropathies, and hypoalbuminemia; Clinically relevant changes in the safety exams are defined as: Blood count o Hb < 10.5 g/dL o Leukocytes < 3,000 /uL or >10,000 cells / uL o Absolute neutrophil count < 1,000 cells/mm3; Coagulation o TP and aPTT > 2.5 x ULN Biochemistry o 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. Leukocyturia > 10,000 cells/mL 5. Any cancer either active or resolved within the last 12 months before screening; 6. Receiving any blood products (except intravenous immunoglobulins) during the last 3 months before screening; 7. Any febrile illness within 14 days before enrollment; Note: The patient may be rescreened after recovery. 8. History of thrombotic events (including myocardial infarction, stroke, pulmonary embolism, and deep vein thrombosis) within 6 months before enrollment; 9. Previous use of live attenuated virus vaccines; 10. Selective deficiency of immunoglobulin A (IgA) or known antibodies to IgA; 11. Known drug or alcohol abuse; 12. The need to use other investigational drugs, systemic immunosuppressants, and any other immunoglobulins; 13. Pregnancy or lactation; 14. Inability to comply with the protocol activities; 15. PIDs other than CVID or X-linked agammaglobulinemia 16. Patients infected with HIV, HBV or HCV 17. Patients with AIDS, cystic fibrosis, or active hepatitis B or C. 18. Any other condition that, in the Investigator's opinion may increase the risk of participation in this study.