Ignite Creation Date:
2025-12-25 @ 2:34 AM
Ignite Modification Date:
2025-12-30 @ 10:24 AM
Study NCT ID:
NCT05245734
Status:
RECRUITING
Last Update Posted:
2024-04-18
First Post:
2022-01-06
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Human Anti-D (rh) Immunoglobulin (Rhesoglobin) Efficacy, Safety and Some Pharmacokinetics Parameters in Pregnant Women
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D012204', 'term': 'Rh-Hr Blood-Group System'}, {'id': 'D007136', 'term': 'Immunoglobulins'}], 'ancestors': [{'id': 'D001789', 'term': 'Blood Group Antigens'}, {'id': 'D000954', 'term': 'Antigens, Surface'}, {'id': 'D000941', 'term': 'Antigens'}, {'id': 'D001685', 'term': 'Biological Factors'}, {'id': 'D007519', 'term': 'Isoantigens'}, {'id': 'D007162', 'term': 'Immunoproteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'uncontrolled, open-label, multicenter, international (From the total number of patients a subgroup for studying some pharmacokinetics parameters is formed )'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 281}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-02-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2025-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-04-17', 'studyFirstSubmitDate': '2022-01-06', 'studyFirstSubmitQcDate': '2022-02-08', 'lastUpdatePostDateStruct': {'date': '2024-04-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-02-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Serum clearance', 'timeFrame': '3 months after first administration of the study drug', 'description': 'Pharmacokinetic parameter are determined after first administration of the study drug'}, {'measure': 'volume of distribution', 'timeFrame': '3 months after first administration of the study drug', 'description': 'Pharmacokinetic parameter are determined after first administration of the study drug'}, {'measure': 'Area under the curve (AUC)', 'timeFrame': '3 months after first administration of the study drug', 'description': 'Pharmacokinetic parameter are determined after first administration of the study drug'}, {'measure': 'Half-life time (T1/2 α and β)', 'timeFrame': '3 months after first administration of the study drug', 'description': 'Pharmacokinetic parameter are determined after first administration of the study drug'}, {'measure': 'Maximum/peak serum concentration (Cmax)', 'timeFrame': '3 months after first administration of the study drug', 'description': 'Pharmacokinetic parameter are determined after first administration of the study drug'}, {'measure': 'Time to reach the maximum serum concentration (Tmax)', 'timeFrame': '3 months after first administration of the study drug', 'description': 'Pharmacokinetic parameter are determined after first administration of the study drug'}, {'measure': 'Elimination rate constant (Kel)', 'timeFrame': '3 months after first administration of the study drug', 'description': 'Pharmacokinetic parameter are determined after first administration of the study drug'}], 'primaryOutcomes': [{'measure': 'The part of patients with no antibodies to Rh0 (D) antigen', 'timeFrame': '6 months after the last administration of the drug', 'description': 'The proportion of patients with no antibodies to Rh0 (D) antigen 6 months after the last administration of the drug'}], 'secondaryOutcomes': [{'measure': 'Titer of anti-Rh0 (D) antibodies', 'timeFrame': '3 months after delivery', 'description': 'Titer of anti-Rh0 (D) antibodies 3 months after delivery'}, {'measure': 'Titer of anti-Rh0 (D) antibodies', 'timeFrame': '6 months after delivery', 'description': 'Titer of anti-Rh0 (D) antibodies 6 months after delivery'}, {'measure': 'The part of patients with no antibodies to Rh0 (D) antigen 3 months after delivery', 'timeFrame': '3 months after the last administration of the drug', 'description': 'Proportion of patients with no antibodies to Rh0 (D) antigen 3 months after the last administration of the drug'}, {'measure': 'Proportion of patients who developed adverse events and reactions (AE / AR)', 'timeFrame': '9 months from the first administration of the drug', 'description': 'Proportion of patients who developed adverse events and reactions (AE / AR) associated with the administration of the drug, stratified by severity'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Rh-immunization prevention', 'human anti-D (rh) immunoglobulin', 'Rh-negative women', 'prenatal prophylaxis', 'postnatal prophylaxis'], 'conditions': ['Pregnancy Related']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.ema.europa.eu/en/clinical-investigation-human-anti-d-immunoglobulin-intravenous-andor-intramuscular-use', 'label': 'European Medicines Agency Guideline for Clinical investigation of human anti-D immunoglobulin for intravenous and/or intramuscular use, CPMP/BPWG/575/99 Rev. 1'}]}, 'descriptionModule': {'briefSummary': "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.", 'detailedDescription': '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.\n\nThe clinical stage\n\nAccording 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:\n\n* Serum clearance\n* Volume of distribution\n* AUC (area under curve)\n* Т1/2 (α and β) (half-life time)\n* Cmax (maximum/peak serum concentration)\n* Tmax (time to reach the maximum serum concentration)\n* Kel (elimination rate constant)\n\nThe 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.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': 'The study will include pregnant women', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Rh-negative women who are not sensitized to Rh0 (D) antigen between the ages of 18 and 45;\n* signed informed patient consent to participate in the study;\n* pregnancy from a Rh-positive man;\n* 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);\n* body mass index should be within normal limits (\\> 18.5 kg / m2 and \\<30.0 kg / m2);\n* 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;\n* persons who do not have acute and chronic cardiovascular, neuroendocrine, kidney, liver diseases, diseases of gastrointestinal tract, respiratory system;\n* 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;\n* the ability, according to the researcher, to comply with all the requirements of the study protocol.\n\nExclusion Criteria:\n\n* sensitization to Rh0 (D) antigen;\n* the absence of reliable anamnestic data on the prevention of Rh incompatibility in previous pregnancy (s) with the birth of a Rh-positive child;\n* selective IgA deficiency in the presence of antibodies against immunoglobulin A (IgA);\n* history of severe allergic reactions to the administration of human blood protein preparations;\n* hypersensitivity reactions to human donor immunoglobulins;\n* severe thrombocytopenia and other hemostatic disorders;\n* life-threatening conditions and / or complications that require intensive care / surgery, the presence of any other bleeding at the time of screening;\n* Rh-negative fetus;\n* any other concomitant decompensated diseases or acute conditions, the presence of which, according to the researcher, can significantly affect the study results;\n* participation in any other clinical trial in the last 3 months and throughout the study.\n\nAdditional exclusion criteria:\n\nSubgroup "Pharmacokinetics" (patients included in the additional study of some pharmacokinetic parameters):\n\n* 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;\n* presence of HIV, hepatitis B, or C viruses;\n* presence of severe clinical and laboratory manifestations of impaired liver and kidney function'}, 'identificationModule': {'nctId': 'NCT05245734', 'briefTitle': 'Human Anti-D (rh) Immunoglobulin (Rhesoglobin) Efficacy, Safety and Some Pharmacokinetics Parameters in Pregnant Women', 'organization': {'class': 'INDUSTRY', 'fullName': 'Biopharma Plasma LLC'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': '1901-RH-BF'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Main group', 'description': '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.\n\nBefore 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.\n\n15 participants from the Main group are formed the "Pharmacokinetics" subgroup for additional blood samples taking, to determine the pharmacokinetic parameters', 'interventionNames': ['Drug: Human Anti-D (rh) immunoglobulin']}], 'interventions': [{'name': 'Human Anti-D (rh) immunoglobulin', 'type': 'DRUG', 'otherNames': ['Rhesoglobin'], 'description': '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.', 'armGroupLabels': ['Main group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '18000', 'city': 'Cherkasy', 'state': 'Cherkasy Oblast', 'status': 'NOT_YET_RECRUITING', 'country': 'Ukraine', 'contacts': [{'name': 'Vladyslav Pochynok', 'role': 'CONTACT'}, {'name': 'Vladyslav Pochynok', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Nataliia Lakusta, Ph.D', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Nataliia Oleksyna', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Municipal non-profit enterprise "Cherkasy Regional Hospital of Cherkasy Regional Council"', 'geoPoint': {'lat': 49.44452, 'lon': 32.05738}}, {'zip': '14000', 'city': 'Chernihiv', 'status': 'NOT_YET_RECRUITING', 'country': 'Ukraine', 'contacts': [{'name': 'Olena Trykashna', 'role': 'CONTACT'}, {'name': 'Olena Trykashna', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Vasyl Husak', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Ivan Lysenko', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Municipal non-profit enterprise "Maternity hospital" of the Chernihiv city council', 'geoPoint': {'lat': 51.50541, 'lon': 31.28656}}, {'zip': '58000', 'city': 'Chernivtsi', 'status': 'RECRUITING', 'country': 'Ukraine', 'contacts': [{'name': 'Vasyl Rynzhuk, Ph.D', 'role': 'CONTACT'}, {'name': 'Vasyl Rynzhuk, Ph.D', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Svitlana Koliandretska', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Natalia Bukh', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Municipal non-profit enterprise "Chernivtsi Regional Perinatal Center"', 'geoPoint': {'lat': 48.29045, 'lon': 25.93241}}, {'zip': '49100', 'city': 'Dnipro', 'status': 'NOT_YET_RECRUITING', 'country': 'Ukraine', 'contacts': [{'name': 'Olha Maltseva, Ph.D.', 'role': 'CONTACT'}, {'name': 'Olha Maltseva, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Oksana Shchyrova, Professor', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Olena Zaiats', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Municipal enterprise "Dnipropetrovsk Regional Perinatal Center (DRPC) with a hospital" of the Dnipropetrovsk Regional Council', 'geoPoint': {'lat': 48.46664, 'lon': 35.04066}}, {'zip': '76000', 'city': 'Ivano-Frankivsk', 'status': 'RECRUITING', 'country': 'Ukraine', 'contacts': [{'name': 'Oksana Makarchuk', 'role': 'CONTACT'}, {'name': 'Oksana Makarchuk', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Volodymyr Liubinets', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Andrii Cheredarchuk', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Municipal non-profit enterprise "Ivano-Frankivsk Regional Perinatal Center Ivano-Frankivsk Regional Council"', 'geoPoint': {'lat': 48.92312, 'lon': 24.71248}}, {'zip': '29013', 'city': 'Khmelnytskyi', 'status': 'RECRUITING', 'country': 'Ukraine', 'contacts': [{'name': 'Olha Pukhliakova', 'role': 'CONTACT'}, {'name': 'Olha Pukhliakova', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Olena Malysh', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Anna Zholkevska', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Municipal non-profit enterprise "Khmelnytsky Regional Hospital" of the Khmelnytsky Regional Council', 'geoPoint': {'lat': 49.41835, 'lon': 26.97936}}, {'zip': '25000', 'city': 'Kropyvnytskyi', 'status': 'RECRUITING', 'country': 'Ukraine', 'contacts': [{'name': 'Tetiana Mitieva', 'role': 'CONTACT'}, {'name': 'Tetiana Mitieva', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Oksana Sliusarenko', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Municipal non-profit enterprise "Kirovohrad Regional Hospital of the Kirovohrad Regional Council"', 'geoPoint': {'lat': 48.50834, 'lon': 32.26618}}, {'zip': '04050', 'city': 'Kyiv', 'status': 'RECRUITING', 'country': 'Ukraine', 'contacts': [{'name': 'Nataliia Skrypchenko, Ph.D., MD', 'role': 'CONTACT'}, {'name': 'Nataliia Skrypchenko, Ph.D., MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Viktoriia Fatiuk, Ph.D', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Oleksandra Khokhlova', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'State Institution "Institute of Pediatrics, Obstetrics and Gynecology named after academician O.M. Lukyanova National Academy of Medical Sciences of Ukraine "', 'geoPoint': {'lat': 50.45466, 'lon': 30.5238}}, {'zip': '04210', 'city': 'Kyiv', 'status': 'RECRUITING', 'country': 'Ukraine', 'contacts': [{'name': 'Shalko Myroslava, Ph.D.', 'role': 'CONTACT'}, {'name': 'Vyacheslav Kaminsky, Professor', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Shalko Myroslava, Ph.D.', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Kyiv City Center for Reproductive and Perinatal Medicine', 'geoPoint': {'lat': 50.45466, 'lon': 30.5238}}, {'zip': '43008', 'city': 'Lutsk', 'status': 'RECRUITING', 'country': 'Ukraine', 'contacts': [{'name': 'Nadiia Shchuruk, Ph.D', 'role': 'CONTACT'}, {'name': 'Nadiia Shchuruk', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Anna Khoronzhuk', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Municipal enterprise "Volyn Regional Territorial Medical Association for the Protection of Motherhood and Childhood" Volyn Regional Council', 'geoPoint': {'lat': 50.75784, 'lon': 25.35024}}, {'zip': '79032', 'city': 'Lviv', 'status': 'RECRUITING', 'country': 'Ukraine', 'contacts': [{'name': 'Mariia Malachynska, Ph.D', 'role': 'CONTACT'}, {'name': 'Mariia Malachynska, Ph.D', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Natalia Veresniuk, Ph.D', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Anzhela Misiura, Ph.D, docent', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Municipal non-profit enterprise Lviv Regional Council "Lviv Regional Clinical Perinatal Center"', 'geoPoint': {'lat': 49.83826, 'lon': 24.02324}}, {'zip': '54058', 'city': 'Mykolayiv', 'status': 'NOT_YET_RECRUITING', 'country': 'Ukraine', 'contacts': [{'name': 'Oleh Kandaurov', 'role': 'CONTACT'}, {'name': 'Oleh Kandaurov', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Kateryna Tivon', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Anzhelika Liubimova', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Municipal non-profit enterprise "Mykolayiv regional clinical hospital" of the Mykolayiv regional council', 'geoPoint': {'lat': 46.97625, 'lon': 31.99296}}, {'zip': '36000', 'city': 'Poltava', 'status': 'NOT_YET_RECRUITING', 'country': 'Ukraine', 'contacts': [{'name': 'Viktoriia Vashchenko', 'role': 'CONTACT'}, {'name': 'Viktoriia Vashchenko', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Olha Kostenko', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Oleksandra Steshenko', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Municipal enterprise "Poltava Regional Clinical Hospital named after M.V. Sklifosovsky Poltava regional council"', 'geoPoint': {'lat': 49.58925, 'lon': 34.55367}}, {'zip': '33000', 'city': 'Rivne', 'status': 'RECRUITING', 'country': 'Ukraine', 'contacts': [{'name': 'Marharyta Tsilinska', 'role': 'CONTACT'}, {'name': 'Marharyta Tsilinska', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Oleh Melnychuk', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Municipal Institution "Regional Perinatal Center" of Rivne Regional Council', 'geoPoint': {'lat': 50.62036, 'lon': 26.23695}}, {'zip': '40000', 'city': 'Sumy', 'status': 'NOT_YET_RECRUITING', 'country': 'Ukraine', 'contacts': [{'name': 'Maryna Kuzomenska, Professor', 'role': 'CONTACT'}, {'name': 'Maryna Kuzomenska, Professor', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Valentyna Kalashnyk', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Tetiana Briazkalo', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Municipal non-profit enterprise Sumy regional council "Regional Clinical Perinatal Center"', 'geoPoint': {'lat': 50.91741, 'lon': 34.79906}}, {'zip': '69071', 'city': 'Zaporizhzhia', 'status': 'NOT_YET_RECRUITING', 'country': 'Ukraine', 'contacts': [{'name': 'Natalia Lutsenko, Professor', 'role': 'CONTACT'}, {'name': 'Natalia Lutsenko, Professor', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Inna Yevterieva, Ph.D.', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Municipal non-profit enterprise "Maternity hospital №3" of Zaporizhia City Council', 'geoPoint': {'lat': 47.15214, 'lon': 35.74246}}], 'centralContacts': [{'name': 'Yaroslav Zhebelenko, Ph.D., MD', 'role': 'CONTACT', 'email': 'y.zhebelenko@biopharma.ua', 'phone': '+380977495979'}, {'name': 'Iryna Stavna', 'role': 'CONTACT', 'email': 'i.stavna@biopharma.ua'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'CSR'], 'timeFrame': 'After the scientific publication of trial results, 3 months later', 'ipdSharing': 'YES', 'description': 'The results will be published after trial completion. Access to parts of Clinical Study Report (CSR) planned after the release of scientific publications.\n\nIndividual participant data (IPD) with the code of each patient will be available In CSR', 'accessCriteria': 'For specialists in field medicine, pharmacy, scientists'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Biopharma Plasma LLC', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'State Institution, Zaporizhzhia Medical Academy of Post-Graduate Education Ministry of Health of Ukraine', 'class': 'OTHER'}, {'name': 'Ivano-Frankivsk National Medical University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}