Human Anti-D (rh) Immunoglobulin (Rhesoglobin) Efficacy, Safety and Some Pharmacokinetics Paramet… (NCT05245734) | Clinical Trial Compass
UnknownPhase 4
Human Anti-D (rh) Immunoglobulin (Rhesoglobin) Efficacy, Safety and Some Pharmacokinetics Parameters in Pregnant Women
Ukraine281 participantsStarted 2022-02-08
Plain-language 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.
Who can participate
Age range18 Years – 45 Years
SexFEMALE
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 hu…
What they're measuring
1
The part of patients with no antibodies to Rh0 (D) antigen
Timeframe: 6 months after the last administration of the drug