Human Anti-D (rh) Immunoglobulin (Rhesoglobin) Efficacy, Safety and Some Pharmacokinetics Parameters in Pregnant Women
- Conditions
- Pregnancy Related
- Interventions
- Drug: Human Anti-D (rh) immunoglobulin
- Registration Number
- NCT05245734
- Lead Sponsor
- Biopharma Plasma LLC
- Brief 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.
- Detailed 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Female
- Target Recruitment
- 281
- 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.
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Main group Human Anti-D (rh) immunoglobulin Patients receive two prophylactic doses of the Human Anti-D (rh) immunoglobulin 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. after the last injection of the drug, blood samples are taken after 3 and 6 months to assess sensitization to the Rh antigen. 15 participants from the Main group are formed the "Pharmacokinetics" subgroup for additional blood samples taking, to determine the pharmacokinetic parameters
- Primary Outcome Measures
Name Time Method The part of patients with no antibodies to Rh0 (D) antigen 6 months after the last administration of the drug The proportion of patients with no antibodies to Rh0 (D) antigen 6 months after the last administration of the drug
- Secondary Outcome Measures
Name Time Method Titer of anti-Rh0 (D) antibodies 6 months after delivery Titer of anti-Rh0 (D) antibodies 6 months after delivery
The part of patients with no antibodies to Rh0 (D) antigen 3 months after delivery 3 months after the last administration of the drug Proportion of patients with no antibodies to Rh0 (D) antigen 3 months after the last administration of the drug
Proportion of patients who developed adverse events and reactions (AE / AR) 9 months from the first administration of the drug Proportion of patients who developed adverse events and reactions (AE / AR) associated with the administration of the drug, stratified by severity
Trial Locations
- Locations (16)
Municipal enterprise "Dnipropetrovsk Regional Perinatal Center (DRPC) with a hospital" of the Dnipropetrovsk Regional Council
🇺🇦Dnipro, Ukraine
Municipal enterprise "Volyn Regional Territorial Medical Association for the Protection of Motherhood and Childhood" Volyn Regional Council
🇺🇦Luts'k, Ukraine
Municipal enterprise "Poltava Regional Clinical Hospital named after M.V. Sklifosovsky Poltava regional council"
🇺🇦Poltava, Ukraine
Municipal non-profit enterprise "Chernivtsi Regional Perinatal Center"
🇺🇦Chernivtsi, Ukraine
Municipal non-profit enterprise "Kirovohrad Regional Hospital of the Kirovohrad Regional Council"
🇺🇦Kropyvnytskyi, Ukraine
Kyiv City Center for Reproductive and Perinatal Medicine
🇺🇦Kyiv, Ukraine
Municipal Institution "Regional Perinatal Center" of Rivne Regional Council
🇺🇦Rivne, Ukraine
Municipal non-profit enterprise Lviv Regional Council "Lviv Regional Clinical Perinatal Center"
🇺🇦Lviv, Ukraine
Municipal non-profit enterprise "Maternity hospital №3" of Zaporizhia City Council
🇺🇦Zaporizhzhia, Ukraine
Municipal non-profit enterprise "Khmelnytsky Regional Hospital" of the Khmelnytsky Regional Council
🇺🇦Khmelnytskyi, Ukraine
Municipal non-profit enterprise "Mykolayiv regional clinical hospital" of the Mykolayiv regional council
🇺🇦Mykolayiv, Ukraine
Municipal non-profit enterprise "Cherkasy Regional Hospital of Cherkasy Regional Council"
🇺🇦Cherkasy, Cherkasy Region, Ukraine
Municipal non-profit enterprise Sumy regional council "Regional Clinical Perinatal Center"
🇺🇦Sumy, Ukraine
Municipal non-profit enterprise "Ivano-Frankivsk Regional Perinatal Center Ivano-Frankivsk Regional Council"
🇺🇦Ivano-Frankivsk, Ukraine
State Institution "Institute of Pediatrics, Obstetrics and Gynecology named after academician O.M. Lukyanova National Academy of Medical Sciences of Ukraine "
🇺🇦Kyiv, Ukraine
Municipal non-profit enterprise "Maternity hospital" of the Chernihiv city council
🇺🇦Chernihiv, Ukraine