Human Anti-D (rh) Immunoglobulin (Rhesoglobin) Efficacy, Safety and Some Pharmacokinetics Parameters in Pregnant Women

Inclusion Criteria:

• Rh-negative women who are not sensitized to Rh0 (D) antigen between the ages of 18 and 45;
• signed informed patient consent to participate in the study;
• pregnancy from a Rh-positive man;
• immunocompetent patients (CD 4+ counts above 200 per μl, HIV negative, or those withthe virus particle count of less than 200 per μl or 400000 per ml);
• body mass index should be within normal limits (> 18.5 kg / m2 and <30.0 kg / m2);
• patients who have not received blood transfusions and / or medicinal productscontaining immunoglobulins in the last 6 months, in particular antibodies to Rh0 (D)antigen;
• persons who do not have acute and chronic cardiovascular, neuroendocrine, kidney,liver diseases, diseases of gastrointestinal tract, respiratory system;
• the results of physical, instrumental and laboratory examination of patients should bewithin the norma or deviations should be regarded by the researcher as clinicallyinsignificant;
• the ability, according to the researcher, to comply with all the requirements of thestudy protocol.

Exclusion Criteria:

• sensitization to Rh0 (D) antigen;
• the absence of reliable anamnestic data on the prevention of Rh incompatibility inprevious pregnancy (s) with the birth of a Rh-positive child;
• selective IgA deficiency in the presence of antibodies against immunoglobulin A (IgA);
• history of severe allergic reactions to the administration of human blood proteinpreparations;
• hypersensitivity reactions to human donor immunoglobulins;
• severe thrombocytopenia and other hemostatic disorders;
• life-threatening conditions and / or complications that require intensive care /surgery, the presence of any other bleeding at the time of screening;
• Rh-negative fetus;
• any other concomitant decompensated diseases or acute conditions, the presence ofwhich, according to the researcher, can significantly affect the study results;
• participation in any other clinical trial in the last 3 months and throughout thestudy. Additional exclusion criteria: Subgroup "Pharmacokinetics" (patients included in the additional study of somepharmacokinetic parameters):
• any previous disease or intervention that, according to the researcher, may affect thepharmacokinetics of the study drug, in particular, organ and bone marrowtransplantation, cancers;
• presence of HIV, hepatitis B, or C viruses;
• presence of severe clinical and laboratory manifestations of impaired liver and kidneyfunction