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

Inclusion criteria:

• Signed Patient Informed Consent Form for participation in the study;

• Men and women aged 18-65;

• Confirmed primary chronic ITP (lasting > 12 months since diagnosis);

• A full blood count should be normal except for the isolated thrombocytopenia.Patients with low hemoglobin levels (but above 90 g / l) may be included if thereare symptoms of bleeding;

• If bleeding symptoms are diagnosed, the reticulocyte count should be measured;

• Platelet count <30 x 109 / L;

• If the patient is taking corticosteroids, the treatment regimen/dose should bestable (at least 2 weeks prior to screening);

• Negative pregnancy test (for women of child-bearing potential);

• Willingness to use effective and reliable methods of contraception throughout theentire study period;

• The results of physical, instrumental, and laboratory examination of patients shouldbe within the normal range or deviations should be regarded by the researcher asclinically insignificant;

• Ability, according to the researcher, to follow all the requirements of the studyprotocol;

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 formedical use;

• Pregnancy and lactation;

• Any clinically significant hepatic impairment (increase of serum transaminase levelsby more than 3 times the upper limit of normal);

• Serum creatinine levels are more than two times higher than the upper limit ofnormal 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 tractassociated with the risk of bleeding, acute infectious diseases, pathologies of therespiratory 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 ofwhich, according to the researcher, may significantly affect the results of thestudy;

• The need to prescribe drugs that are incompatible with the administration of thedrug 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 toinclusion 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;