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

• Status: Recruiting
• Trial end date: 2024-03-01
• Target enrollment: 0
• Participant gender: Female

Summary

Rhesus conflict between mother and fetus is due to the different antigenic composition of erythrocytes. During the first pregnancy, sensitization of the mother to fetal erythrocytes rhesus D (RhD) antigens is formed. During the next pregnancy, fetal red blood cells are attacked by the mother's antibodies, and fetal/newborn hemolytic disease develops. The drug Rhesoglobin blocks the interaction of the fetal erythrocytes RhD antigen and the immune system of the mother and prevents the development of Rhesus sensitization.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Biopharma Plasma LLC
• Collaborators: Ivano-Frankivsk National Medical University; State Institution, Zaporizhzhia Medical Academy of Post-Graduate Education Ministry of Health of Ukraine
• Treatments: Antibodies; gamma-Globulins; Immunoglobulins; Immunoglobulins, Intravenous; Rho(D) Immune Globulin

Criteria

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 with the 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 products containing 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 be within the norma or deviations should be regarded by the researcher as clinically insignificant;

• the ability, according to the researcher, to comply with all the requirements of the study protocol.

Exclusion Criteria:

• sensitization to Rh0 (D) antigen;

• the absence of reliable anamnestic data on the prevention of Rh incompatibility in previous 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 protein preparations;

• 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 of which, according to the researcher, can significantly affect the study results;

• participation in any other clinical trial in the last 3 months and throughout the study.

Additional exclusion criteria:

Subgroup "Pharmacokinetics" (patients included in the additional study of some pharmacokinetic parameters):

• any previous disease or intervention that, according to the researcher, may affect the pharmacokinetics of the study drug, in particular, organ and bone marrow transplantation, cancers;

• presence of HIV, hepatitis B, or C viruses;

• presence of severe clinical and laboratory manifestations of impaired liver and kidney function