Pregnancy Related
Conditions
Keywords
Rh-immunization prevention, human anti-D (rh) immunoglobulin, Rh-negative women, prenatal prophylaxis, postnatal prophylaxis
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.
Interventions
DRUGHuman Anti-D (rh) immunoglobulin
prevention of Rh-sensitization in pregnant women in the antenatal and postnatal period in routine clinical practice. The study drug is administered twice at a dose of 300 mcg - at 28 weeks of gestation and within 72 hours after delivery.
Sponsors
State Institution, Zaporizhzhia Medical Academy of Post-Graduate Education Ministry of Health of Ukraine
Ivano-Frankivsk National Medical University
Biopharma Plasma LLC
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
uncontrolled, open-label, multicenter, international (From the total number of patients a subgroup for studying some pharmacokinetics parameters is formed )
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Titer of anti-Rh0 (D) antibodies | 3 months after delivery | Titer of anti-Rh0 (D) antibodies 3 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 |
Other
| Measure | Time frame | Description |
|---|---|---|
| Maximum/peak serum concentration (Cmax) | 3 months after first administration of the study drug | Pharmacokinetic parameter are determined after first administration of the study drug |
| Serum clearance | 3 months after first administration of the study drug | Pharmacokinetic parameter are determined after first administration of the study drug |
| Elimination rate constant (Kel) | 3 months after first administration of the study drug | Pharmacokinetic parameter are determined after first administration of the study drug |
| Time to reach the maximum serum concentration (Tmax) | 3 months after first administration of the study drug | Pharmacokinetic parameter are determined after first administration of the study drug |
| volume of distribution | 3 months after first administration of the study drug | Pharmacokinetic parameter are determined after first administration of the study drug |
| Area under the curve (AUC) | 3 months after first administration of the study drug | Pharmacokinetic parameter are determined after first administration of the study drug |
| Half-life time (T1/2 α and β) | 3 months after first administration of the study drug | Pharmacokinetic parameter are determined after first administration of the study drug |
Countries
Ukraine
Contacts
Primary ContactYaroslav Zhebelenko, Ph.D., MD
Backup ContactIryna Stavna
Outcome results
None listed