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Pregnancy RelatedPhase 4NCT05245734

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

A Phase 4 study testing Human Anti-D (rh) immunoglobulin in people with Pregnancy Related, run by Biopharma Plasma LLC at 16 sites in Ukraine.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 45 years, women only
Conditions the study is for
Pregnancy Related
What is being tested?
Human Anti-D (rh) immunoglobulin
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
281 participants
Where
16 sitesUkraine
Study dates
8 Feb 2022to Apr 2025
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 45 years
  • Women only
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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;
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  • 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.

Who cannot join

  • 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;
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  • 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

Trial locations and contacts

16 sites in 1 country.

Yaroslav Zhebelenko, Ph.D., MD contact

+380977495979

y.zhebelenko@biopharma.ua

Iryna Stavna contact

i.stavna@biopharma.ua

16 sites in 1 country

Ukraine16 sites, 16 recruiting

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

    Cherkasy, Cherkasy Oblast, 18000

    Vladyslav Pochynok

    Vladyslav Pochynok

    Not yet recruiting

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

    Chernihiv, 14000

    Olena Trykashna

    Olena Trykashna

    Not yet recruiting

  • Municipal non-profit enterprise "Chernivtsi Regional Perinatal Center"

    Chernivtsi, 58000

    Vasyl Rynzhuk, Ph.D

    Vasyl Rynzhuk, Ph.D

    Recruiting

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

    Dnipro, 49100

    Olha Maltseva, Ph.D.

    Olha Maltseva, Ph.D.

    Not yet recruiting

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

    Ivano-Frankivsk, 76000

    Oksana Makarchuk

    Oksana Makarchuk

    Recruiting

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

    Khmelnytskyi, 29013

    Olha Pukhliakova

    Olha Pukhliakova

    Recruiting

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

    Kropyvnytskyi, 25000

    Tetiana Mitieva

    Tetiana Mitieva

    Recruiting

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

    Kyiv, 04050

    Nataliia Skrypchenko, Ph.D., MD

    Nataliia Skrypchenko, Ph.D., MD

    Recruiting

  • Kyiv City Center for Reproductive and Perinatal Medicine

    Kyiv, 04210

    Shalko Myroslava, Ph.D.

    Vyacheslav Kaminsky, Professor

    Recruiting

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

    Lutsk, 43008

    Nadiia Shchuruk, Ph.D

    Nadiia Shchuruk

    Recruiting

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

    Lviv, 79032

    Mariia Malachynska, Ph.D

    Mariia Malachynska, Ph.D

    Recruiting

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

    Mykolayiv, 54058

    Oleh Kandaurov

    Oleh Kandaurov

    Not yet recruiting

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

    Poltava, 36000

    Viktoriia Vashchenko

    Viktoriia Vashchenko

    Not yet recruiting

  • Municipal Institution "Regional Perinatal Center" of Rivne Regional Council

    Rivne, 33000

    Marharyta Tsilinska

    Marharyta Tsilinska

    Recruiting

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

    Sumy, 40000

    Maryna Kuzomenska, Professor

    Maryna Kuzomenska, Professor

    Not yet recruiting

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

    Zaporizhzhya, 69071

    Natalia Lutsenko, Professor

    Natalia Lutsenko, Professor

    Not yet recruiting

Other trials in Ukraine

About this study

Official title: Open-label, Multicenter, International Study of the Efficacy and Safety of the Drug Rhesoglobin (Human Anti-D (rh) Immunoglobulin) Manufactured by Biopharma Plasma LLC, Ukraine, in Pregnant Women in the Antenatal and Postnatal Period in Routine Clinical Practice for the Prevention of Rh Sensitization, With a Subgroup for Evaluation of Some Pharmacokinetic Parameters

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.

Read the 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.

Being tested
Human Anti-D (rh) immunoglobulin
Keywords
Rh-immunization prevention, human anti-D (rh) immunoglobulin, Rh-negative women, prenatal prophylaxis, postnatal prophylaxis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Human Anti-D (rh) immunoglobulinDrug

    Also called Rhesoglobin

    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.

Study groups in NCT05245734
Study groupRoleWhat they receive
Main groupExperimentalPatients 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
Receives: Drug: Human Anti-D (rh) immunoglobulin

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 6 months after the last administration of the drug

Secondary outcomes (4)

  1. Titer of anti-Rh0 (D) antibodies

    Titer of anti-Rh0 (D) antibodies 3 months after delivery

    Measured: 3 months after delivery

  2. Titer of anti-Rh0 (D) antibodies

    Titer of anti-Rh0 (D) antibodies 6 months after delivery

    Measured: 6 months after delivery

  3. The part of patients with no antibodies to Rh0 (D) antigen 3 months after delivery

    Proportion of patients with no antibodies to Rh0 (D) antigen 3 months after the last administration of the drug

    Measured: 3 months after the last administration of the drug

  4. Proportion of patients who developed adverse events and reactions (AE / AR)

    Proportion of patients who developed adverse events and reactions (AE / AR) associated with the administration of the drug, stratified by severity

    Measured: 9 months from the first administration of the drug

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Feb 2022
  2. Study start8 Feb 2022
  3. Primary completionFeb 2025 (estimated)
  4. Study completionApr 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Model description
uncontrolled, open-label, multicenter, international (From the total number of patients a subgroup for studying some pharmacokinetics parameters is formed )
Masking
None (open label)
Enrolment
281 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05245734
Sponsor's protocol ID
1901-RH-BF
Status last verified
Apr 2024
First submitted
6 Jan 2022
Last updated
18 Apr 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: The results will be published after trial completion. Access to parts of Clinical Study Report (CSR) planned after the release of scientific publications. Individual participant data (IPD) with the code of each patient will be available In CSR

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Human Anti-D (rh) immunoglobulin in people with Pregnancy Related, run by Biopharma Plasma LLC at 16 sites in Ukraine.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 18 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 16 sites in Ukraine. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Yaroslav Zhebelenko, Ph.D., MD (+380977495979, y.zhebelenko@biopharma.ua), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The part of patients with no antibodies to Rh0 (D) antigen (time frame: 6 months after the last administration of the drug). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05245734.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Apr 2024.

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