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Preventing Rh-immunization in Pregnant Women with Human Anti-D Immunoglobulin

Open-label, Multicenter, International Study of the Efficacy and Safety of the Drug Rhesoglobin (Human Anti-D (rh) Immunoglobulin) Manufactured by Biopharma Plasma LLC, Ukraine, in Pregnant Women in the Antenatal and Postnatal Period in Routine Clinical Practice for the Prevention of Rh Sensitization, With a Subgroup for Evaluation of Some Pharmacokinetic Parameters

Phase 4 Interventional Biopharma Plasma LLC · NCT05245734

This study is testing a new treatment to see if it can help prevent Rh-negative pregnant women from developing antibodies that could affect future pregnancies.

Quick facts

PhasePhase 4
Study typeInterventional
Enrollment281 (estimated)
Ages18 Years to 45 Years
SexFemale
SponsorBiopharma Plasma LLC Industry-sponsored
Locations16 sites (Cherkasy, Cherkasy Region and 15 other locations)
Trial IDNCT05245734 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the efficacy and safety of Human Anti-D (rh) immunoglobulin, known as Rhesoglobin, in preventing Rh sensitization in Rh-negative pregnant women. Participants will receive two doses of the drug: one at 28 weeks of gestation and another within 72 hours after delivery if they have an Rh-positive child. Blood samples will be collected to monitor anti-Rh0 (D) antibody levels and assess pharmacokinetic parameters. The study aims to ensure that mothers do not develop antibodies that could harm future pregnancies.

Who should consider this trial

Good fit: Ideal candidates are Rh-negative women aged 18 to 45 who are not sensitized to Rh0 (D) antigen and are pregnant with an Rh-positive partner.

Not a fit: Patients who are already sensitized to Rh0 (D) antigen or have underlying health conditions that disqualify them from participation may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly reduce the risk of hemolytic disease in newborns caused by Rh incompatibility.

How similar studies have performed: Previous studies have shown success in using immunoglobulin therapies for Rh sensitization prevention, indicating a promising approach.

Eligibility criteria

Show full inclusion / exclusion 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

Where this trial is running

Cherkasy, Cherkasy Region and 15 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Pregnancy RelatedRh-immunization preventionhuman anti-D immunoglobulinRh-negative womenprenatal prophylaxispostnatal prophylaxis
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.