Status:
RECRUITING
Human Anti-D (rh) Immunoglobulin (Rhesoglobin) Efficacy, Safety and Some Pharmacokinetics Parameters in Pregnant Women
Lead Sponsor:
Biopharma Plasma LLC
Collaborating Sponsors:
State Institution, Zaporizhzhia Medical Academy of Post-Graduate Education Ministry of Health of Ukraine
Ivano-Frankivsk National Medical University
Conditions:
Pregnancy Related
Eligibility:
FEMALE
18-45 years
Phase:
PHASE4
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) ant...
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 (...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 8 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2025
Estimated Enrollment :
281 Patients enrolled
Trial Details
Trial ID
NCT05245734
Start Date
February 8 2022
End Date
April 1 2025
Last Update
April 18 2024
Active Locations (16)
Enter a location and click search to find clinical trials sorted by distance.
1
Municipal non-profit enterprise "Cherkasy Regional Hospital of Cherkasy Regional Council"
Cherkasy, Cherkasy Oblast, Ukraine, 18000
2
Municipal non-profit enterprise "Maternity hospital" of the Chernihiv city council
Chernihiv, Ukraine, 14000
3
Municipal non-profit enterprise "Chernivtsi Regional Perinatal Center"
Chernivtsi, Ukraine, 58000
4
Municipal enterprise "Dnipropetrovsk Regional Perinatal Center (DRPC) with a hospital" of the Dnipropetrovsk Regional Council
Dnipro, Ukraine, 49100