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

NCT05245734 | Recruiting Phase 4

• 1 other identifier: 1901-RH-BF
• Study Type: interventional
• Target: 281
• Locations: 1 country
• Sites: 16

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.

Conditions

Pregnancy Related

Keywords

Rh-immunization prevention; human anti-D (rh) immunoglobulin; Rh-negative women; prenatal prophylaxis; postnatal prophylaxis

Outcome Measures

Primary Outcomes (1)

• The part of patients with no antibodies to Rh0 (D) antigen

  The proportion of patients with no antibodies to Rh0 (D) antigen 6 months after the last administration of the drug

  6 months after the last administration of the drug

Secondary Outcomes (4)

• Titer of anti-Rh0 (D) antibodies

  3 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 who developed adverse events and reactions (AE / AR)

  9 months from the first administration of the drug

Other Outcomes (7)

• Serum clearance

  3 months after first administration of the study drug

• volume of distribution

  3 months after first administration of the study drug

• Area under the curve (AUC)

  3 months after first administration of the study drug

Study Arms (1)

Main group

EXPERIMENTAL

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

Drug: Human Anti-D (rh) immunoglobulin

Interventions

Human Anti-D (rh) immunoglobulin 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.

Also known as: Rhesoglobin

Main group

Eligibility Criteria

• Age: 18 Years - 45 Years
• Gender Eligibility Details: The study will include pregnant women
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Biopharma Plasma LLC: lead
• State Institution, Zaporizhzhia Medical Academy of Post-Graduate Education Ministry of Health of Ukraine: collaborator
• Ivano-Frankivsk National Medical University: collaborator

Study Sites (16)

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

Cherkasy, Cherkasy Oblast, 18000, Ukraine

NOT YET RECRUITING

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

Chernihiv, 14000, Ukraine

NOT YET RECRUITING

Municipal non-profit enterprise "Chernivtsi Regional Perinatal Center"

Chernivtsi, 58000, Ukraine

RECRUITING

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

Dnipro, 49100, Ukraine

NOT YET RECRUITING

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

Ivano-Frankivsk, 76000, Ukraine

RECRUITING

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

Khmelnytskyi, 29013, Ukraine

RECRUITING

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

Kropyvnytskyi, 25000, Ukraine

RECRUITING

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

Kyiv, 04050, Ukraine

RECRUITING

Kyiv City Center for Reproductive and Perinatal Medicine

Kyiv, 04210, Ukraine

RECRUITING

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

Lutsk, 43008, Ukraine

RECRUITING

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

Lviv, 79032, Ukraine

RECRUITING

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

Mykolayiv, 54058, Ukraine

NOT YET RECRUITING

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

Poltava, 36000, Ukraine

NOT YET RECRUITING

Municipal Institution "Regional Perinatal Center" of Rivne Regional Council

Rivne, 33000, Ukraine

RECRUITING

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

Sumy, 40000, Ukraine

NOT YET RECRUITING

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

Zaporizhzhia, 69071, Ukraine

NOT YET RECRUITING

Related Links

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

MeSH Terms

Interventions

Rh-Hr Blood-Group System; Immunoglobulins

Intervention Hierarchy (Ancestors)

Blood Group Antigens; Antigens, Surface; Antigens; Biological Factors; Isoantigens; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Central Study Contacts

Yaroslav Zhebelenko, Ph.D., MD

CONTACT

+380977495979; y.zhebelenko@biopharma.ua

Iryna Stavna

CONTACT

i.stavna@biopharma.ua

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: uncontrolled, open-label, multicenter, international (From the total number of patients a subgroup for studying some pharmacokinetics parameters is formed )

Study Record Dates

• First Submitted: January 6, 2022
• First Posted: February 18, 2022
• Study Start: February 8, 2022
• Primary Completion: February 1, 2025
• Study Completion: April 1, 2025
• Last Updated: April 18, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: After the scientific publication of trial results, 3 months later
• Access Criteria: For specialists in field medicine, pharmacy, scientists

Locations

UA (16)