drugset / Trial / NCT05245734
Human Anti-D (rh) Immunoglobulin (Rhesoglobin) Efficacy, Safety and Some Pharmacokinetics Parameters in Pregnant Women
Phase 4
Unknown
281 enrolled
Biopharma Plasma LLC
Ivano-Frankivsk National Medical University · collabState Institution, Zaporizhzhia Medical Academy of Post-Graduate Education Ministry of Health of Ukraine · collab
NaSingle-groupOpen-labelPrevention
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.
Timeline
- Start
- 2022-02-08
- Primary completion
- 2025-02
- Completion
- 2025-04
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Human Anti-D (rh) immunoglobulin | Unknown | 300 ug | — |