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

  • STATUS
    Recruiting
  • End date
    Mar 23, 2024
  • participants needed
    281
  • sponsor
    Biopharma Plasma LLC
Updated on 23 March 2022

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.

Description

The screening stage The pregnant woman (participant) has to sign an informed consent. After the signed informed consent procedure, the patient is assessed for meeting the inclusion and non-inclusion (exclusion) criteria. Patients who were included in the study are assessed according to additional criteria for inclusion in the "Pharmacokinetics" subgroup.

The clinical stage

According to the study protocol, patients receive two prophylactic doses of the study drug at a dose of 300 mcg - at 28 weeks of gestation and within 72 hours after delivery. Patients receive the second dose only in the case of the birth of an Rh-positive child. Before and after each injection of the drug, blood will be taken to control the level of anti-Rh0 (D) antibodies. In the "Pharmacokinetics" subgroup, additional blood samples will be taken to determine the following pharmacokinetic parameters:

  • Serum clearance
  • Volume of distribution
  • AUC (area under curve)
  • Т1/2 (α and β) (half-life time)
  • Cmax (maximum/peak serum concentration)
  • Tmax (time to reach the maximum serum concentration)
  • Kel (elimination rate constant)

The final stage The patient should be monitored for 6 months ± 5 days, after the last injection of the drug, blood samples are taken after 3 and 6 months to assess sensitization to the Rh antigen.

Details
Condition Pregnancy Related
Treatment Human Anti-D (rh) immunoglobulin
Clinical Study IdentifierNCT05245734
SponsorBiopharma Plasma LLC
Last Modified on23 March 2022

Eligibility

Yes No Not Sure

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
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