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:
Participant gender:
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
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