Ignite Creation Date:
2025-12-25 @ 12:01 AM
Ignite Modification Date:
2025-12-25 @ 9:59 PM
Study NCT ID:
NCT04058158
Status:
COMPLETED
Last Update Posted:
2024-03-26
First Post:
2019-08-12
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
A Study to Compare SB12 (Proposed Eculizumab Biosimilar) to Soliris in Subjects With Paroxysmal Nocturnal Haemoglobinuria
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006457', 'term': 'Hemoglobinuria, Paroxysmal'}], 'ancestors': [{'id': 'D000743', 'term': 'Anemia, Hemolytic'}, {'id': 'D000740', 'term': 'Anemia'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D009190', 'term': 'Myelodysplastic Syndromes'}, {'id': 'D001855', 'term': 'Bone Marrow Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C034730', 'term': 'zwittergent 3-12'}, {'id': 'C481642', 'term': 'eculizumab'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'sbregistry@samsung.com', 'phone': '+82-32-728-0371', 'title': 'Director of Clinical Trials', 'organization': 'Samsung Bioepis Co., Ltd'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'From the time of signing the informed consent form until Week 58 (EOS Visit) or ET Visit', 'eventGroups': [{'id': 'EG000', 'title': 'SB12', 'description': 'SB12 treated group', 'otherNumAtRisk': 47, 'deathsNumAtRisk': 47, 'otherNumAffected': 18, 'seriousNumAtRisk': 47, 'deathsNumAffected': 0, 'seriousNumAffected': 3}, {'id': 'EG001', 'title': 'Soliris', 'description': 'Soliris treated group', 'otherNumAtRisk': 47, 'deathsNumAtRisk': 47, 'otherNumAffected': 11, 'seriousNumAtRisk': 47, 'deathsNumAffected': 1, 'seriousNumAffected': 2}], 'otherEvents': [{'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numEvents': 6, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 47, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Corona virus infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 47, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 47, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numEvents': 4, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 47, 'numEvents': 5, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Haemoglobinuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numEvents': 15, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 47, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 47, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Hand fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 47, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Haemolysis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 47, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Infusion site hypersensitivity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 47, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Portal vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 47, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 47, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Wound infection bacterial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 47, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Lactate Dehydrogenase (U/L) at Week 26', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'SB12', 'description': 'SB12 treated group'}, {'id': 'OG001', 'title': 'Soliris', 'description': 'Soliris treated group'}], 'classes': [{'categories': [{'measurements': [{'value': '284.20', 'spread': '456.73', 'groupId': 'OG000'}, {'value': '249.72', 'spread': '103.67', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Least squares mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '34.48', 'ciLowerLimit': '-47.66', 'ciUpperLimit': '116.62', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': 'Pre-defined equivalence margin was \\[-337.2 to 337.2\\].'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Week 26', 'unitOfMeasure': 'U/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Per-Protocol Set for LDH at a Single Time Point'}, {'type': 'PRIMARY', 'title': 'Time-adjusted AUEC of LDH From Week 14 to Week 26 and From Week 40 to Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'SB12', 'description': 'SB12 treated group'}, {'id': 'OG001', 'title': 'Soliris', 'description': 'Soliris treated group'}], 'classes': [{'categories': [{'measurements': [{'value': '279.65', 'spread': '325.37', 'groupId': 'OG000'}, {'value': '258.73', 'spread': '95.09', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio of geometric least squares mean', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '1.08', 'ciLowerLimit': '0.95', 'ciUpperLimit': '1.23', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': 'Pre-defined equivalence margin was \\[0.77 to 1.29\\].'}], 'paramType': 'GEOMETRIC_LEAST_SQUARES_MEAN', 'timeFrame': 'From Week 14 to Week 26 and from Week 40 to Week 52', 'unitOfMeasure': 'U/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Per-Protocol Set for AUEC of LDH'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Soliris to SB12', 'description': 'Subjects randomly assigned to treatment with Soliris received 600 mg of eculizumab intravenous (IV) infusion every week for first 4 weeks (initial phase) and 900 mg for the fifth week, followed by 900 mg every 2 weeks thereafter.'}, {'id': 'FG001', 'title': 'SB12 to Soliris', 'description': 'Subjects randomly assigned to treatment with SB12 received 600 mg of eculizumab intravenous (IV) infusion every week for first 4 weeks (initial phase) and 900 mg for the fifth week, followed by 900 mg every 2 weeks thereafter.'}], 'periods': [{'title': 'Period 1', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '25'}, {'groupId': 'FG001', 'numSubjects': '25'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '23'}, {'groupId': 'FG001', 'numSubjects': '23'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Pregnancy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}, {'title': 'Period 2', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '23'}, {'groupId': 'FG001', 'numSubjects': '23'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '23'}, {'groupId': 'FG001', 'numSubjects': '23'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '50', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Soliris to SB12', 'description': 'Subjects randomly assigned to treatment with Soliris received 600 mg of eculizumab intravenous (IV) infusion every week for first 4 weeks (initial phase) and 900 mg for the fifth week, followed by 900 mg every 2 weeks thereafter. Subjects who were randomized to initially receive Soliris were switched to receive SB12 at Week 26.'}, {'id': 'BG001', 'title': 'SB12 to Soliris', 'description': 'Subjects randomly assigned to treatment with SB12 received 600 mg of eculizumab intravenous (IV) infusion every week for first 4 weeks (initial phase) and 900 mg for the fifth week, followed by 900 mg every 2 weeks thereafter. Subjects who were randomized to initially receive SB12 were switched to receive Soliris at Week 26.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '36.3', 'spread': '13.67', 'groupId': 'BG000'}, {'value': '40.0', 'spread': '13.44', 'groupId': 'BG001'}, {'value': '38.1', 'spread': '13.55', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '28', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '27', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-11-27', 'size': 2462398, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2023-09-14T04:27', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-08-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'completionDateStruct': {'date': '2021-10-21', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-03-25', 'studyFirstSubmitDate': '2019-08-12', 'resultsFirstSubmitDate': '2023-09-14', 'studyFirstSubmitQcDate': '2019-08-13', 'lastUpdatePostDateStruct': {'date': '2024-03-26', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-03-25', 'studyFirstPostDateStruct': {'date': '2019-08-15', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-03-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-09-21', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Lactate Dehydrogenase (U/L) at Week 26', 'timeFrame': 'Week 26'}, {'measure': 'Time-adjusted AUEC of LDH From Week 14 to Week 26 and From Week 40 to Week 52', 'timeFrame': 'From Week 14 to Week 26 and from Week 40 to Week 52'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Paroxysmal Nocturnal Hemoglobinuria']}, 'descriptionModule': {'briefSummary': 'This is a randomised Phase III, double-blind, multicentre, cross-over study to compare the efficacy, safety, pharmacokinetics, and immunogenicity between SB12 and Soliris® in subjects with PNH.', 'detailedDescription': 'Subjects will be randomised in a 1:1 ratio to either treatment sequence. Subjects randomly assigned to treatment with SB12 or Soliris® will receive 600 mg of eculizumab IV every week for first 4 weeks (initial phase) and 900 mg for the fifth week, followed by 900 mg every 2 weeks until Week 52. Subjects who are randomised to initially receive SB12 will be switched to receive Soliris® and subjects who are randomised to initially receive Soliris® will be switched to receive SB12 at Week 26.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or female aged 18 or older\n* Eculizumab-naïve patients with PNH\n* Presence of the PNH white blood cell (WBC) clone ≥ 10%\n* Documented LDH level ≥ 1.5 x ULN at Screening\n* History of transfusion for anaemia within 12 months prior to Screening or having PNH-related symptoms at Screening\n* Subjects must be vaccinated against Neisseria meningitides\n\nExclusion Criteria:\n\n* Previous treatment with any complement pathway inhibitors\n* ANC ≤ 500/mm3 or Platelet count \\< 70,000/mm3\n* History of meningococcal disease\n* History of bone marrow transplantation\n* Known or suspected active bacterial/viral/fungal infection within 30 days\n* Stable use of erythropoietic, corticosteroids, heparin, warfarin before randomisation'}, 'identificationModule': {'nctId': 'NCT04058158', 'briefTitle': 'A Study to Compare SB12 (Proposed Eculizumab Biosimilar) to Soliris in Subjects With Paroxysmal Nocturnal Haemoglobinuria', 'organization': {'class': 'INDUSTRY', 'fullName': 'Samsung Bioepis Co., Ltd.'}, 'officialTitle': 'A Phase III Randomised, Double-blind, Multicentre Study to Compare the Efficacy, Safety, Pharmacokinetics, and Immunogenicity Between SB12 (Proposed Eculizumab Biosimilar) and Soliris® in Subjects With Paroxysmal Nocturnal Haemoglobinuria', 'orgStudyIdInfo': {'id': 'SB12-3003'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment Sequence I', 'description': 'Subjects who are randomised to initially receive SB12 will be switched to receive Soliris® at Week 26', 'interventionNames': ['Drug: SB12 (proposed eculizumab biosimilar)', 'Drug: Soliris (eculizumab)']}, {'type': 'EXPERIMENTAL', 'label': 'Treatment Sequence II', 'description': 'Subjects who are randomised to initially receive Soliris® will be switched to receive SB12 at Week 26', 'interventionNames': ['Drug: SB12 (proposed eculizumab biosimilar)', 'Drug: Soliris (eculizumab)']}], 'interventions': [{'name': 'SB12 (proposed eculizumab biosimilar)', 'type': 'DRUG', 'description': '600 mg IV every week for first 4 weeks and 900 mg for the fifth week, followed by 900 mg every 2 weeks thereafter', 'armGroupLabels': ['Treatment Sequence I', 'Treatment Sequence II']}, {'name': 'Soliris (eculizumab)', 'type': 'DRUG', 'description': '600 mg IV every week for first 4 weeks and 900 mg for the fifth week, followed by 900 mg every 2 weeks thereafter', 'armGroupLabels': ['Treatment Sequence I', 'Treatment Sequence II']}]}, 'contactsLocationsModule': {'locations': [{'zip': '122002', 'city': 'Gurgaon', 'state': 'Haryana', 'country': 'India', 'facility': 'Fortis Memorial Research Institute', 'geoPoint': {'lat': 28.4601, 'lon': 77.02635}}, {'city': 'Chandigarh', 'country': 'India', 'facility': 'Post Graduate Institute of Medical Education and Research (PGIMER)', 'geoPoint': {'lat': 30.73629, 'lon': 76.7884}}, {'city': 'Chennai', 'country': 'India', 'facility': 'Apollo Hospitals International Limited', 'geoPoint': {'lat': 13.08784, 'lon': 80.27847}}, {'city': 'Kochi', 'country': 'India', 'facility': 'Amrita Institute of Medical Sciences and Research Centre', 'geoPoint': {'lat': 9.93988, 'lon': 76.26022}}, {'city': 'Kolkata', 'country': 'India', 'facility': 'Nil Ratan Sircar Medical College and Hospital', 'geoPoint': {'lat': 22.56263, 'lon': 88.36304}}, {'city': 'Ampang', 'country': 'Malaysia', 'facility': 'Hospital Ampang', 'geoPoint': {'lat': 3.15, 'lon': 101.76667}}, {'city': 'Johor Bahru', 'country': 'Malaysia', 'facility': 'Hospital Sultanah Aminah', 'geoPoint': {'lat': 1.4655, 'lon': 103.7578}}, {'city': 'Kota Kinabalu', 'country': 'Malaysia', 'facility': 'Queen Elizabeth Hospital - Kota Kinabalu', 'geoPoint': {'lat': 5.9749, 'lon': 116.0724}}, {'city': 'Kuantan', 'country': 'Malaysia', 'facility': 'Hospital Tengku Ampuan Afzan', 'geoPoint': {'lat': 3.8077, 'lon': 103.326}}, {'city': 'Pulau Pinang', 'country': 'Malaysia', 'facility': 'Hospital Pulau Pinang', 'geoPoint': {'lat': 3.55, 'lon': 102.56667}}, {'city': 'Tlalpan', 'country': 'Mexico', 'facility': 'Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran', 'geoPoint': {'lat': 19.29513, 'lon': -99.16206}}, {'city': 'Bucharest', 'country': 'Romania', 'facility': 'Colentina Clinical Hospital', 'geoPoint': {'lat': 44.43225, 'lon': 26.10626}}, {'city': 'Bucharest', 'country': 'Romania', 'facility': 'Emergency University Hospital', 'geoPoint': {'lat': 44.43225, 'lon': 26.10626}}, {'city': 'Cluj-Napoca', 'country': 'Romania', 'facility': 'Prof Dr I Chiricuta Institute of Oncology', 'geoPoint': {'lat': 46.76667, 'lon': 23.6}}, {'city': 'Craiova', 'country': 'Romania', 'facility': 'Filantropia Municipal Clinical Hospital', 'geoPoint': {'lat': 44.31667, 'lon': 23.8}}, {'city': 'Seoul', 'country': 'South Korea', 'facility': 'Samsung Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Seoul', 'country': 'South Korea', 'facility': 'Seoul National University Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Tainan', 'country': 'Taiwan', 'facility': 'National Cheng Kung University Hospital', 'geoPoint': {'lat': 22.99083, 'lon': 120.21333}}, {'city': 'Taipei', 'country': 'Taiwan', 'facility': 'National Taiwan University Hospital', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}, {'city': 'Taipei', 'country': 'Taiwan', 'facility': 'Tri-Service General Hospital', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}, {'city': 'Taoyuan District', 'country': 'Taiwan', 'facility': 'Chang Gung Memorial Hospital', 'geoPoint': {'lat': 24.9896, 'lon': 121.3187}}, {'city': 'Bangkok', 'country': 'Thailand', 'facility': 'Chulalongkorn University', 'geoPoint': {'lat': 13.75398, 'lon': 100.50144}}, {'city': 'Nai Muang', 'country': 'Thailand', 'facility': 'Srinagarind Hospital', 'geoPoint': {'lat': 15.17901, 'lon': 100.1282}}, {'zip': '21018', 'city': 'Vinnytsia', 'state': 'Vinnytsia Oblast', 'country': 'Ukraine', 'facility': 'Vinnytsia Regional Clinical Hospital n.a. M.I.Pyrohov', 'geoPoint': {'lat': 49.2322, 'lon': 28.46871}}, {'zip': '18009', 'city': 'Cherkasy', 'country': 'Ukraine', 'facility': 'Municipal Institution Cherkasy Regional Oncology Dispensary of Cherkasy Regional Council', 'geoPoint': {'lat': 49.44452, 'lon': 32.05738}}, {'city': 'Kharkiv', 'country': 'Ukraine', 'facility': 'Communal Non-profit Enterprise Regional Center of Oncology', 'geoPoint': {'lat': 49.98177, 'lon': 36.25475}}, {'city': 'Poltava', 'country': 'Ukraine', 'facility': 'Poltava Regional Clinical Hospital n.a. M.V. Sklifosovskyi', 'geoPoint': {'lat': 49.58925, 'lon': 34.55367}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Samsung Bioepis Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}