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

NCT ID: NCT05245734

Last Updated: 2024-04-18

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 281 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-02-08
• Study Completion Date: 2025-04-30

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.

Conditions

Pregnancy Related

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Main group

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

Group Type: EXPERIMENTAL

Human Anti-D (rh) immunoglobulin

Intervention Type: DRUG

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.

Interventions

Human 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.

Intervention Type: DRUG

Other Intervention Names

Rhesoglobin

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.

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

State Institution, Zaporizhzhia Medical Academy of Post-Graduate Education Ministry of Health of Ukraine

OTHER

Sponsor Role: collaborator

Ivano-Frankivsk National Medical University

OTHER

Sponsor Role: collaborator

Biopharma Plasma LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Municipal non-profit enterprise "Cherkasy Regional Hospital of Cherkasy Regional Council"

Cherkasy, Cherkasy Oblast, Ukraine

Site Status: NOT_YET_RECRUITING

Municipal non-profit enterprise "Maternity hospital" of the Chernihiv city council

Chernihiv, , Ukraine

Site Status: NOT_YET_RECRUITING

Municipal non-profit enterprise "Chernivtsi Regional Perinatal Center"

Chernivtsi, , Ukraine

Site Status: RECRUITING

Municipal enterprise "Dnipropetrovsk Regional Perinatal Center (DRPC) with a hospital" of the Dnipropetrovsk Regional Council

Dnipro, , Ukraine

Site Status: NOT_YET_RECRUITING

Municipal non-profit enterprise "Ivano-Frankivsk Regional Perinatal Center Ivano-Frankivsk Regional Council"

Ivano-Frankivsk, , Ukraine

Site Status: RECRUITING

Municipal non-profit enterprise "Khmelnytsky Regional Hospital" of the Khmelnytsky Regional Council

Khmelnytskyi, , Ukraine

Site Status: RECRUITING

Municipal non-profit enterprise "Kirovohrad Regional Hospital of the Kirovohrad Regional Council"

Kropyvnytskyi, , Ukraine

Site Status: RECRUITING

State Institution "Institute of Pediatrics, Obstetrics and Gynecology named after academician O.M. Lukyanova National Academy of Medical Sciences of Ukraine "

Kyiv, , Ukraine

Site Status: RECRUITING

Kyiv City Center for Reproductive and Perinatal Medicine

Kyiv, , Ukraine

Site Status: RECRUITING

Municipal enterprise "Volyn Regional Territorial Medical Association for the Protection of Motherhood and Childhood" Volyn Regional Council

Lutsk, , Ukraine

Site Status: RECRUITING

Municipal non-profit enterprise Lviv Regional Council "Lviv Regional Clinical Perinatal Center"

Lviv, , Ukraine

Site Status: RECRUITING

Municipal non-profit enterprise "Mykolayiv regional clinical hospital" of the Mykolayiv regional council

Mykolayiv, , Ukraine

Site Status: NOT_YET_RECRUITING

Municipal enterprise "Poltava Regional Clinical Hospital named after M.V. Sklifosovsky Poltava regional council"

Poltava, , Ukraine

Site Status: NOT_YET_RECRUITING

Municipal Institution "Regional Perinatal Center" of Rivne Regional Council

Rivne, , Ukraine

Site Status: RECRUITING

Municipal non-profit enterprise Sumy regional council "Regional Clinical Perinatal Center"

Sumy, , Ukraine

Site Status: NOT_YET_RECRUITING

Municipal non-profit enterprise "Maternity hospital №3" of Zaporizhia City Council

Zaporizhzhia, , Ukraine

Site Status: NOT_YET_RECRUITING

Countries

Ukraine

Central Contacts

Yaroslav Zhebelenko, Ph.D., MD

Role: CONTACT

y.zhebelenko@biopharma.ua

+380977495979

Iryna Stavna

Role: CONTACT

i.stavna@biopharma.ua

Facility Contacts

Vladyslav Pochynok

Role: primary

Olena Trykashna

Role: primary

Vasyl Rynzhuk, Ph.D

Role: primary

Olha Maltseva, Ph.D.

Role: primary

Oksana Makarchuk

Role: primary

Olha Pukhliakova

Role: primary

Tetiana Mitieva

Role: primary

Nataliia Skrypchenko, Ph.D., MD

Role: primary

Shalko Myroslava, Ph.D.

Role: primary

Nadiia Shchuruk, Ph.D

Role: primary

Mariia Malachynska, Ph.D

Role: primary

Oleh Kandaurov

Role: primary

Viktoriia Vashchenko

Role: primary

Marharyta Tsilinska

Role: primary

Maryna Kuzomenska, Professor

Role: primary

Natalia Lutsenko, Professor

Role: primary

Related Links

https://www.ema.europa.eu/en/clinical-investigation-human-anti-d-immunoglobulin-intravenous-andor-intramuscular-use

European Medicines Agency Guideline for Clinical investigation of human anti-D immunoglobulin for intravenous and/or intramuscular use, CPMP/BPWG/575/99 Rev. 1

Other Identifiers

1901-RH-BF

Identifier Type: -

Identifier Source: org_study_id