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

Launched by BIOPHARMA PLASMA LLC · Feb 8, 2022

Keywords

ClinConnect Summary

This clinical trial is studying a medication called Rhesoglobin, which is designed to help prevent problems that can occur during pregnancy when a mother’s blood type (specifically Rh-negative) conflicts with her baby's blood type (Rh-positive). If this conflict happens, the mother's immune system can attack the baby's red blood cells, leading to serious health issues for the baby. The goal of the study is to see how well Rhesoglobin works, how safe it is, and to gather some information about how the body processes this medication in pregnant women.

Women who might be eligible to participate in this trial are those who are Rh-negative, not already sensitized to the RhD antigen, and between the ages of 18 and 45. They must be pregnant with a baby whose father is Rh-positive and should not have had any blood transfusions or certain medications in the last six months. Participants will be closely monitored throughout the study to ensure their safety and to gather important information about the medication's effectiveness. If you or someone you know fits these criteria and is interested, it’s a good idea to discuss it with a healthcare provider for more information.

Gender

FEMALE

Eligibility 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