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

NCT05245734 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 281

Last updated 2024-04-18

No results posted yet for this study

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.

Conditions

  • Pregnancy Related

Interventions

DRUG

Human Anti-D (rh) immunoglobulin

prevention of Rh-sensitization in pregnant women in the antenatal and postnatal period in routine clinical practice. The study drug is administered twice at a dose of 300 mcg - at 28 weeks of gestation and within 72 hours after delivery.

Sponsors & Collaborators

  • State Institution, Zaporizhzhia Medical Academy of Post-Graduate Education Ministry of Health of Ukraine

    collaborator OTHER

  • Ivano-Frankivsk National Medical University

    collaborator OTHER

  • Biopharma Plasma LLC

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-02-08
Primary Completion
2025-02-28
Completion
2025-04-30

Countries

  • Ukraine

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05245734 on ClinicalTrials.gov