Intravenous Immunoglobulin (IVIG, Bioven) Efficacy and Safety in Chronic Primary Immune Thrombocytopenia (ITP) in Adults

Exclusion Criteria

• •Known intolerance to plasma and immunoglobulin preparations;
• •Drug allergy or hypersensitivity to immunoglobulin preparations;
• •Confirmed deficiency of immunoglobulin A (IgA) and antibodies to IgA.
• •Contraindications to immunoglobulin administration according to the instructions for medical use;
• •Pregnancy and lactation;
• •Any clinically significant hepatic impairment (increase of serum transaminase levels by more than 3 times the upper limit of normal);
• •Serum creatinine levels are more than two times higher than the upper limit of normal for a given age and sex;
• •Severe cardiovascular insufficiency (HF III);
• •History of thrombosis or presence of significant risk factors for thrombosis.
• •Patients with preventive splenectomy;
• •Hemostatic disorders other than chronic thrombocytopenia;
• •Persons with acute or exacerbation of chronic diseases of the gastrointestinal tract associated with the risk of bleeding, acute infectious diseases, pathologies of the respiratory system;
• •Proven case of primary immunodeficiency;
• •Secondary immune thrombocytopenia;
• •Virus infections (Epstein-Barr, Cytomegalovirus, Parvovirus, Hepatitis B and C);
• •Documented HIV infection
• •Positive reaction of Wassermann (RW) test result;
• •Systemic immunopathological diseases (rheumatic diseases, nephritis, etc.);
• •Oncological diseases;
• •Diabetes mellitus;
• •Thyroid diseases;
• •History of mental illness;
• •Known drug addiction;
• •Any other concomitant decompensated diseases or acute conditions, the presence of which, according to the researcher, may significantly affect the results of the study;
• •The need to prescribe drugs that are incompatible with the administration of the drug in this study: other immunoglobulin preparations in addition to the study drug, cytostatic drugs, monoclonal antibodies, Avatrombopag);
• •Experimental treatment (e.g. Rituximab therapy) for 3 months prior to screening);
• •Blood transfusions or transfusions of blood products in the last 6 months prior to inclusion in the study;
• •Administration of IVIG 30 days prior to screening;
• •Participation in any other study currently or within the last 30 days;
• •Criteria for exclusion of subjects (discontinuation of treatment with the study drug):
• •Patient's wish
• •Occurrence of severe and/or unexpected Adverse events (AE) or Adverse reactions (AR) in patient during the study, that require discontinuation of the drug;
• •The need to prescribe drugs prohibited in this study.
• •Significant deterioration of the patient's condition during the study period;
• •Failure of the patient to adhere to the treatment regimen;
• •Failure of the patient to follow the procedures established under the protocol;