Ignite Creation Date:
2025-12-24 @ 2:32 PM
Ignite Modification Date:
2026-04-22 @ 4:49 PM
Study NCT ID:
NCT05135559
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-11-19
First Post:
2021-11-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Research Study on How Well Concizumab Works for You if You Have Haemophilia A or B With or Without Inhibitors
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Russia']}, 'conditionBrowseModule': {'meshes': [{'id': 'D006467', 'term': 'Hemophilia A'}], 'ancestors': [{'id': 'D025861', 'term': 'Blood Coagulation Disorders, Inherited'}, {'id': 'D001778', 'term': 'Blood Coagulation Disorders'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D020147', 'term': 'Coagulation Protein Disorders'}, {'id': 'D006474', 'term': 'Hemorrhagic Disorders'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C574488', 'term': 'concizumab'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 153}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2022-03-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'nctId': 'NCT04921956', 'statusForNctId': 'AVAILABLE', 'hasExpandedAccess': True}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2029-11-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-18', 'studyFirstSubmitDate': '2021-11-15', 'studyFirstSubmitQcDate': '2021-11-15', 'lastUpdatePostDateStruct': {'date': '2025-11-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2021-11-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-04-21', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'For inhibitor patients with at least 26 weeks on-demand treatment during the last 52 weeks prior enrolment: Number of treated spontaneous and traumatic bleeding episodes', 'timeFrame': 'From start of treatment (week 0) up until the primary analysis cut-off (at least 32 weeks)', 'description': 'Count of episode(s)'}, {'measure': 'For non-inhibitor patients treated on demand during at least the last 52 weeks prior enrolment: Number of treated spontaneous and traumatic bleeding episodes', 'timeFrame': 'From start of treatment (week 0) up until the primary analysis cut-off (at least 32 weeks)', 'description': 'Count of episode(s)'}], 'secondaryOutcomes': [{'measure': 'For inhibitor patients with at least 26 weeks on-demand treatment during the last 52 weeks prior enrolment: Number of all bleeding episodes (spontaneous and traumatic)', 'timeFrame': 'From start of treatment (week 0) up until the primary analysis cut-off (at least 32 weeks)', 'description': 'Count of episode(s)'}, {'measure': 'For inhibitor patients with at least 26 weeks on-demand treatment during the last 52 weeks prior enrolment: Number of treated spontaneous bleeding episodes', 'timeFrame': 'From start of treatment (week 0) up until the primary analysis cut-off (at least 32 weeks)', 'description': 'Count of episode(s)'}, {'measure': 'For inhibitor patients with at least 26 weeks on-demand treatment during the last 52 weeks prior enrolment: Number of treated joint bleeding episodes', 'timeFrame': 'From start of treatment (week 0) up until the primary analysis cut-off (at least 32 weeks)', 'description': 'Count of episode(s)'}, {'measure': 'For inhibitor patients with at least 26 weeks on-demand treatment during the last 52 weeks prior enrolment: Number of treated bleeding episodes in baseline target joints', 'timeFrame': 'From start of treatment (week 0) up until the primary analysis cut-off (at least 32 weeks)', 'description': 'Count of episode(s)'}, {'measure': 'For non-inhibitor patients treated on-demand during at least the last 52 weeks prior enrolment: Number of all bleeding episodes (spontaneous and traumatic)', 'timeFrame': 'From start of treatment (week 0) up until the primary analysis cut-off (at least 32 weeks)', 'description': 'Count of episode(s)'}, {'measure': 'For non-inhibitor patients treated on-demand during at least the last 52 weeks prior enrolment: Number of treated spontaneous bleeding episodes', 'timeFrame': 'From start of treatment (week 0) up until the primary analysis cut-off (at least 32 weeks)', 'description': 'Count of episode(s)'}, {'measure': 'For non-inhibitor patients treated on-demand at least the last 52 weeks prior enrolment: Number of treated joint bleeding episodes', 'timeFrame': 'From start of treatment (week 0) up until the primary analysis cut-off (at least 32 weeks)', 'description': 'Count of episode(s)'}, {'measure': 'For non-inhibitor patients treated on-demand at least the last 52 weeks prior enrolment: Number of treated bleeding episodes in baseline target joints', 'timeFrame': 'From start of treatment (week 0) up until the primary analysis cut-off (at least 32 weeks)', 'description': 'Count of episode(s)'}, {'measure': 'For non-inhibitor patients with at least 26 weeks PPX treatment during the last 52 weeks prior enrolment: Number of treated spontaneous and traumatic bleeding episodes', 'timeFrame': 'From start of treatment (week 0) up until the primary analysis cut-off (at least 32 weeks)', 'description': 'Count of episode(s)'}, {'measure': 'For non-inhibitor patients with at least 26 weeks PPX treatment during the last 52 weeks prior enrolment: Number of all bleeding episodes (spontaneous and traumatic)', 'timeFrame': 'From start of treatment (week 0) up until the primary analysis cut-off (at least 32 weeks)', 'description': 'Count of episode(s)'}, {'measure': 'For non-inhibitor patients with at least 26 weeks PPX treatment during the last 52 weeks prior enrolment: Number of treated spontaneous bleeding episodes', 'timeFrame': 'From start of treatment (week 0) up until the primary analysis cut-off (at least 32 weeks)', 'description': 'Count of episode(s)'}, {'measure': 'For non-inhibitor patients with at least 26 weeks PPX treatment during the last 52 weeks prior enrolment: Number of treated joint bleeding episodes', 'timeFrame': 'From start of treatment (week 0) up until the primary analysis cut-off (at least 32 weeks)', 'description': 'Count of episode(s)'}, {'measure': 'For non-inhibitor patients with at least 26 weeks PPX treatment during the last 52 weeks prior enrolment: Number of treated bleeding episodes in baseline target joints', 'timeFrame': 'From start of treatment (week 0) up until the primary analysis cut-off (at least 32 weeks)', 'description': 'Count of episode(s)'}, {'measure': 'Concizumab-naïve pateints - Number of treatment emergent adverse events, reported both separately for inhibitor and non-inhibitor patients and combined', 'timeFrame': 'From start of treatment (week 0) up until the primary analysis cut-off (at least 32 weeks)', 'description': 'Count of event(s)'}, {'measure': 'Number of thromboembolic events, reported both separately for inhibitor and non-inhibitor patients and combined', 'timeFrame': 'From start of treatment (week 0) up until the primary analysis cut-off (at least 32 weeks)', 'description': 'Count of event(s)'}, {'measure': 'Number of hypersensitivity type reactions, reported both separately for inhibitor and non-inhibitor patients and combined', 'timeFrame': 'From start of treatment (week 0) up until the primary analysis cut-off (at least 32 weeks)', 'description': 'Count of event(s)'}, {'measure': 'Number of injection site reactions, reported both separately for inhibitor and non-inhibitor patients and combined', 'timeFrame': 'From start of treatment (week 0) up until the primary analysis cut-off (at least 32 weeks)', 'description': 'Count of event(s)'}, {'measure': 'Number of patients who develop antibodies to concizumab - yes/no, reported both separately for inhibitor and non-inhibitor patients and combined', 'timeFrame': 'From start of treatment (week 0) up until the primary analysis cut-off (at least 32 weeks)', 'description': 'Count of patient(s)'}, {'measure': 'Number of treatment emergent adverse events, reported both separately for inhibitor and non-inhibitor patients and combined', 'timeFrame': 'From start of treatment (week 0) up until the primary analysis cut-off (at least 32 weeks)', 'description': 'Count of event(s)'}, {'measure': 'Concizumab plasma concentrations prior to dosing, reported both separately for inhibitor and non-inhibitor patients and combined', 'timeFrame': 'Week 32', 'description': 'Measured in ng/mL'}, {'measure': 'Peak thrombin generation prior to dosing, reported both separately for inhibitor and non-inhibitor patients and combined', 'timeFrame': 'Week 32', 'description': 'Measured in nM'}, {'measure': 'Free TFPI concentration prior to dosing, reported both separately for inhibitor and non-inhibitor patients and combined', 'timeFrame': 'Week 32', 'description': 'Measured in ng/mL'}, {'measure': 'Pre-dose (trough) concizumab plasma concentration (Ctrough), reported both separately for inhibitor and non-inhibitor patients and combined', 'timeFrame': 'Prior to the concizumab administration at week 20', 'description': 'Measured in ng/mL'}, {'measure': 'Maximum concizumab plasma concentration (Cmax), reported both separately for inhibitor and non-inhibitor patients and combined', 'timeFrame': 'From 0 to 24 hours where 0 is the time of the concizumab dose at week 20', 'description': 'Measured in ng/mL'}, {'measure': 'Area under the concizumab plasma concentration-time curve (AUC), reported both separately for inhibitor and non-inhibitor patients and combined', 'timeFrame': 'From 0 to 24 hours where 0 is the time of the concizumab dose at week 20', 'description': 'Measured in ng\\*hr/mL'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Haemophilia A and B With and Without Inhibitors']}, 'descriptionModule': {'briefSummary': 'This study will test how well a new medicine called concizumab works for participants who have haemophilia A or B with or without inhibitors. The purpose is to show that concizumab can prevent bleeds and is safe to use.\n\nParticipants will have to inject the study medicine every day under the skin with a pen-injector.\n\nThe study will last for at least 2 years and up to about 4 years. The length of time the participant will be in the study depends on if the study medicine will be available for purchase in their country.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Informed consent/assent obtained before any study-related activities. Study-related activities are any procedures that are carried out as part of the study, including activities to determine suitability for the study.\n* Diagnosis of congenital severe haemophilia A (FVIII below 1%) or moderate/severe congenital haemophilia B (FIX (coagulation factor IX) below or equal to 2%), or congenital haemophilia with inhibitors.\n* For arm 1 only: Male aged below 12 years of age at the time of signing informed consent.\n* For arm 1 only: Patients with inhibitors (haemophilia A with inhibitors or haemophilia B with inhibitors)\n\n 1. Patients with HAwI (haemophilia A with inhibitors) with historical medical records of a total of at least 26 weeks of on-demand treatment (On-demand or PPX treatment qualifying for this study is understood as patient-treatment solely for bleeds with intravenous coagulation factor-containing products) within the last 52 weeks prior to enrolment (For patients below 1 year of age that have been diagnosed with haemophilia \\<1 year prior to enrolment, historical medical records from time of diagnosis will suffice as long as medical records of a total of at least 26 weeks of relevant treatment is available).\n 2. Patients with HBwI (haemophilia B with inhibitors) with historical medical records of a total of at least 26 weeks of on-demand treatment (On-demand or PPX treatment qualifying for this study is understood as patient-treatment solely for bleeds with intravenous coagulation factor-containing products) within the last 52 weeks prior to enrolment (For patients below 1 year of age that have been diagnosed with haemophilia \\<1 year prior to enrolment, historical medical records from time of diagnosis will suffice as long as medical records of a total of at least 26 weeks of relevant treatment is available).\n 3. Patients with HBwI regardless of the regimen and duration of previous haemophilia treatment (On-demand or PPX treatment qualifying for this study is understood as patient-treatment solely for bleeds with intravenous coagulation factor-containing products)\n* For arm 1 only: Patients without inhibitors (haemophilia A or haemophilia B)\n\n 1. Patients with historical medical records of at least 52 weeks of on-demand treatment (On-demand or PPX treatment qualifying for this study is understood as patient-treatment solely for bleeds with intravenous coagulation factor-containing products; Surgery related PPX or short-term PPX (e.g., in relation to a severe bleed) is not allowed) during the last year prior to enrolment and with at least 3 documented treated bleeds (For participants less than (\\<) 2 years of age there is no limitation for number of documented treated bleeds in the medical history) during this period\n 2. Patients with historical medical records of a total of at least 26 weeks of PPX (prophylaxis) treatment (On-demand or PPX treatment qualifying for this study is understood as patient-treatment solely for bleeds with intravenous coagulation factor-containing products) within the last 52 weeks prior to enrolment (For patients below 1 year of age that have been diagnosed with haemophilia \\<1 year prior to enrolment, historical medical records from time of diagnosis will suffice as long as medical records of a total of at least 26 weeks of relevant treatment is available)\n* For arm 2 only: Male patients (regardless of age) previously treated with concizumab via compassionate use.\n\nExclusion Criteria:\n\n* Known or suspected hypersensitivity to study intervention or related products.\n* Known inherited or acquired coagulation disorder other than congenital haemophilia.\n* Ongoing or planned Immune Tolerance Induction treatment.\n* History of thromboembolic disease (aIncludes arterial and venous thrombosis including myocardial infarction, pulmonary embolism, cerebral infarction/thrombosis, deep vein thrombosis, other clinically significant thromboembolic events and peripheral artery occlusion.). Current clinical signs of or treatment for thromboembolic disease. Patients who in the judgement of the investigator are considered at high risk of thromboembolic events (Thromboembolic risk factors could include, but are not limited to, hypercholesterolemia, diabetes mellitus, hypertension, obesity, smoking, family history of thromboembolic events, arteriosclerosis, other conditions associated with increased risk of thromboembolic events).'}, 'identificationModule': {'nctId': 'NCT05135559', 'acronym': 'Explorer10', 'briefTitle': 'A Research Study on How Well Concizumab Works for You if You Have Haemophilia A or B With or Without Inhibitors', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novo Nordisk A/S'}, 'officialTitle': 'Open-label Study Investigating Efficacy, Safety and Pharmacokinetics of Concizumab Prophylaxis in Children Below 12 Years With Haemophilia A or B With or Without Inhibitors', 'orgStudyIdInfo': {'id': 'NN7415-4616'}, 'secondaryIdInfos': [{'id': 'U1111-1247-7330', 'type': 'OTHER', 'domain': 'World Health Organization (WHO)'}, {'id': '2020-000504-11', 'type': 'EUDRACT_NUMBER'}, {'id': 'jRCT2031220097', 'type': 'REGISTRY', 'domain': 'JAPIC'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Concizumab-naïve patients', 'description': 'Concizumab-naïve participants below 12 years of age at the time of consent/assent', 'interventionNames': ['Drug: Concizumab']}, {'type': 'EXPERIMENTAL', 'label': 'Patients coming from compassionate use', 'description': 'Patients previously treated with concizumab via compassionate use, either on an individual patient basis or through the concizumab compassionate use programme NN7415-4807', 'interventionNames': ['Drug: Concizumab']}], 'interventions': [{'name': 'Concizumab', 'type': 'DRUG', 'description': 'Participants in Arm 1 will be assigned to concizumab prophylaxis starting with a loading dose on treatment day 0 followed by daily injections of an individual maintenance dose.\n\nParticipants in Arm 2 will be assigned to concizumab prophylaxis with daily injections of an individual maintenance dose.', 'armGroupLabels': ['Concizumab-naïve patients', 'Patients coming from compassionate use']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92123', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'Rady Childrens Hosp San Diego', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '80045', 'city': 'Aurora', 'state': 'Colorado', 'country': 'United States', 'facility': 'University of Colorado Hospital', 'geoPoint': {'lat': 39.72943, 'lon': -104.83192}}, {'zip': '32806', 'city': 'Orlando', 'state': 'Florida', 'country': 'United States', 'facility': "Arnold Palmer Children's Hospital", 'geoPoint': {'lat': 28.53834, 'lon': -81.37924}}, {'zip': '32827', 'city': 'Orlando', 'state': 'Florida', 'country': 'United States', 'facility': 'Nemours Child Orlando Hem/Onc.', 'geoPoint': {'lat': 28.53834, 'lon': -81.37924}}, {'zip': '30912', 'city': 'Augusta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Augusta Univ/Childrens Hosp-GA', 'geoPoint': {'lat': 33.47097, 'lon': -81.97484}}, {'zip': '31404', 'city': 'Savannah', 'state': 'Georgia', 'country': 'United States', 'facility': 'Memorial Health University Medical Center', 'geoPoint': {'lat': 32.08354, 'lon': -81.09983}}, {'zip': '60611', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Childrens Hospital of Chicago', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '46260', 'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'facility': 'Indiana Hemophilia-Thromb Ctr', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}, {'zip': '70118', 'city': 'New Orleans', 'state': 'Louisiana', 'country': 'United States', 'facility': "Children's Hosp-New Orleans", 'geoPoint': {'lat': 29.95465, 'lon': -90.07507}}, {'zip': '70121', 'city': 'New Orleans', 'state': 'Louisiana', 'country': 'United States', 'facility': 'Ochsner Clinic Foundation', 'geoPoint': {'lat': 29.95465, 'lon': -90.07507}}, {'zip': '64108', 'city': 'Kansas City', 'state': 'Missouri', 'country': 'United States', 'facility': "The Children's Mercy Hospital", 'geoPoint': {'lat': 39.09973, 'lon': -94.57857}}, {'zip': '68114', 'city': 'Omaha', 'state': 'Nebraska', 'country': 'United States', 'facility': "Children's Nebraska", 'geoPoint': {'lat': 41.25626, 'lon': -95.94043}}, {'zip': '27834', 'city': 'Greenville', 'state': 'North Carolina', 'country': 'United States', 'facility': 'ECU Sickle Cell Comp Clinic', 'geoPoint': {'lat': 35.61266, 'lon': -77.36635}}, {'zip': '43205', 'city': 'Columbus', 'state': 'Ohio', 'country': 'United States', 'facility': "Nationwide Children's Hospital", 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}, {'zip': '19134', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'St Christopher Hosp for Child', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '37212', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Vanderbilt Hemostasis Treatment Clinic', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'zip': '76104', 'city': 'Fort Worth', 'state': 'Texas', 'country': 'United States', 'facility': "Cook Children's Hospital-Hematology-Oncology", 'geoPoint': {'lat': 32.72541, 'lon': -97.32085}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': "Texas Children's Hospital_Houston", 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '22908', 'city': 'Charlottesville', 'state': 'Virginia', 'country': 'United States', 'facility': 'Pediatrics Hematology/Oncology Clinic Battle Building', 'geoPoint': {'lat': 38.02931, 'lon': -78.47668}}, {'zip': '16000', 'city': 'Algiers', 'country': 'Algeria', 'facility': 'Haematology and Blood Bank Department', 'geoPoint': {'lat': 36.73225, 'lon': 3.08746}}, {'zip': '25000', 'city': 'Constantine', 'country': 'Algeria', 'facility': 'CHU Constantine BEN BADIS/ Hematology department', 'geoPoint': {'lat': 36.365, 'lon': 6.61472}}, {'zip': '78000', 'city': 'Banja Luka', 'country': 'Bosnia and Herzegovina', 'facility': 'University Clinical Center of Republic Srpska (545)', 'geoPoint': {'lat': 44.77879, 'lon': 17.20629}}, {'zip': '75000', 'city': 'Tuzla', 'country': 'Bosnia and Herzegovina', 'facility': 'University Clinical Centre Tuzla', 'geoPoint': {'lat': 44.53842, 'lon': 18.66709}}, {'zip': '4002', 'city': 'Plovdiv', 'country': 'Bulgaria', 'facility': 'UMHAT Sveti Georgi EAD, Plovdiv, Clinic of Pediatrics', 'geoPoint': {'lat': 42.15387, 'lon': 24.75001}}, {'zip': '1527', 'city': 'Sofia', 'country': 'Bulgaria', 'facility': 'UMHAT Tsaritsa Yoanna-ISUL EAD', 'geoPoint': {'lat': 42.69751, 'lon': 23.32415}}, {'zip': '9010', 'city': 'Varna', 'country': 'Bulgaria', 'facility': 'UMHAT "Sveta Marina" EAD', 'geoPoint': {'lat': 43.21912, 'lon': 27.91024}}, {'zip': 'V6H 3V4', 'city': 'Vancouver', 'state': 'British Columbia', 'country': 'Canada', 'facility': "BC Children's Hospital", 'geoPoint': {'lat': 49.24966, 'lon': -123.11934}}, {'zip': 'L8N 3Z5', 'city': 'Hamilton', 'state': 'Ontario', 'country': 'Canada', 'facility': "McMaster Children's Hospital", 'geoPoint': {'lat': 43.25011, 'lon': -79.84963}}, {'zip': '13419', 'city': 'Tallinn', 'country': 'Estonia', 'facility': "Tallinn Children's Hospital", 'geoPoint': {'lat': 59.43696, 'lon': 24.75353}}, {'zip': '73000', 'city': 'Chambéry', 'country': 'France', 'facility': 'Centre Hospitalier Metropole Savoie', 'geoPoint': {'lat': 45.56628, 'lon': 5.92079}}, {'zip': '94275', 'city': 'Le Kremlin-Bicêtre', 'country': 'France', 'facility': 'Ap-Hp-Hopital de Bicetre-1', 'geoPoint': {'lat': 48.81471, 'lon': 2.36073}}, {'zip': '75015', 'city': 'Paris', 'country': 'France', 'facility': 'Ap-Hp-Hopital Necker-1', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': 'GR-11527', 'city': 'Athens', 'country': 'Greece', 'facility': "Aghia Sophia Childrens' Hospital", 'geoPoint': {'lat': 37.98376, 'lon': 23.72784}}, {'zip': '54642', 'city': 'Thessaloniki', 'country': 'Greece', 'facility': "'Ippokrateio' General Hospital of Thessaloniki", 'geoPoint': {'lat': 40.64072, 'lon': 22.93493}}, {'zip': 'GR 54642', 'city': 'Thessaloniki', 'country': 'Greece', 'facility': "'Ippokrateio' General Hospital of Thessaloniki", 'geoPoint': {'lat': 40.64072, 'lon': 22.93493}}, {'zip': '781032', 'city': 'Guwahati', 'state': 'Assam', 'country': 'India', 'facility': 'Guwahati Medical College', 'geoPoint': {'lat': 26.1844, 'lon': 91.7458}}, {'zip': '395002', 'city': 'Surat', 'state': 'Gujarat', 'country': 'India', 'facility': 'Nirmal Hospital Pvt. Ltd.', 'geoPoint': {'lat': 21.19594, 'lon': 72.83023}}, {'zip': '416005', 'city': 'Kolhāpur', 'state': 'Maharashtra', 'country': 'India', 'facility': 'SSSH_Dept. of Clinical Haematology & Haemato Oncology', 'geoPoint': {'lat': 16.69563, 'lon': 74.23167}}, {'zip': '400012', 'city': 'Mumbai', 'state': 'Maharashtra', 'country': 'India', 'facility': 'Seth GS Medical College & KEM Hospital', 'geoPoint': {'lat': 19.07283, 'lon': 72.88261}}, {'zip': '400022', 'city': 'Mumbai', 'state': 'Maharashtra', 'country': 'India', 'facility': 'K.J Somaiya Hospital and Research Centre', 'geoPoint': {'lat': 19.07283, 'lon': 72.88261}}, {'zip': '400066', 'city': 'Mumbai', 'state': 'Maharashtra', 'country': 'India', 'facility': 'MCGM - Comprehensive Thalassemia Care', 'geoPoint': {'lat': 19.07283, 'lon': 72.88261}}, {'zip': '411004', 'city': 'Pune', 'state': 'Maharashtra', 'country': 'India', 'facility': 'Sahyadri Super Speciality Hospital', 'geoPoint': {'lat': 18.51957, 'lon': 73.85535}}, {'zip': '753007', 'city': 'Cuttack', 'state': 'Odisha', 'country': 'India', 'facility': 'S.C.B. Medical College', 'geoPoint': {'lat': 20.46497, 'lon': 85.87927}}, {'zip': '302004', 'city': 'Jaipur', 'state': 'Rajasthan', 'country': 'India', 'facility': 'J K Lon Hospital', 'geoPoint': {'lat': 26.91962, 'lon': 75.78781}}, {'zip': '201303', 'city': 'Noida', 'state': 'Uttar Pradesh', 'country': 'India', 'facility': 'Post Graduate Institute of Child Health', 'geoPoint': {'lat': 28.58, 'lon': 77.33}}, {'zip': '226014', 'city': 'Lucknow', 'state': 'Uttart Pradesh', 'country': 'India', 'facility': 'SGPGI', 'geoPoint': {'lat': 26.83928, 'lon': 80.92313}}, {'zip': '95123', 'city': 'Catania', 'country': 'Italy', 'facility': 'A.O.U policlinico "G. Rodolico-San Marco"', 'geoPoint': {'lat': 37.49223, 'lon': 15.07041}}, {'zip': '50134', 'city': 'Florence', 'country': 'Italy', 'facility': 'Dipartimento di Ematologia Univ. Firenze', 'geoPoint': {'lat': 43.77925, 'lon': 11.24626}}, {'zip': '35128', 'city': 'Padua', 'country': 'Italy', 'facility': 'Azienda Ospedaliera di Padova', 'geoPoint': {'lat': 45.40797, 'lon': 11.88586}}, {'zip': '43126', 'city': 'Parma', 'country': 'Italy', 'facility': 'Azienda Ospedaliera-Universitaria Parma', 'geoPoint': {'lat': 44.79935, 'lon': 10.32618}}, {'zip': '216-8511', 'city': 'Kanagawa', 'country': 'Japan', 'facility': 'St. Marianna University School of Medicine Hospital_Pediatrics', 'geoPoint': {'lat': 37.58333, 'lon': 139.91667}}, {'zip': '330-8777', 'city': 'Saitama', 'country': 'Japan', 'facility': "Saitama Children's Med Centre_Hematology-Oncology", 'geoPoint': {'lat': 35.90807, 'lon': 139.65657}}, {'zip': '961', 'city': 'Beirut', 'country': 'Lebanon', 'facility': 'Saint George Hospital University Medical Center', 'geoPoint': {'lat': 33.89332, 'lon': 35.50157}}, {'zip': '1434', 'city': 'Tripoli', 'country': 'Lebanon', 'facility': 'Hospital Nini', 'geoPoint': {'lat': 34.43352, 'lon': 35.84415}}, {'zip': 'LT-08406', 'city': 'Vilnius', 'country': 'Lithuania', 'facility': 'Centre of Oncology and Hematology, Vilnius University', 'geoPoint': {'lat': 54.68916, 'lon': 25.2798}}, {'zip': '50300', 'city': 'Kampung Baru', 'state': 'Kuala Lumpur', 'country': 'Malaysia', 'facility': 'Hospital Tunku Azizah', 'geoPoint': {'lat': 3.16544, 'lon': 101.70394}}, {'zip': '10450', 'city': 'George Town', 'state': 'Pulau Pinang', 'country': 'Malaysia', 'facility': 'Hospital Pulau Pinang', 'geoPoint': {'lat': 5.41123, 'lon': 100.33543}}, {'zip': '93586', 'city': 'Kuching', 'state': 'Sarawak', 'country': 'Malaysia', 'facility': 'Sarawak General Hospital', 'geoPoint': {'lat': 1.55, 'lon': 110.33333}}, {'zip': '20400', 'city': 'Kuala Terengganu', 'state': 'Terengganu', 'country': 'Malaysia', 'facility': 'Hospital Sultanah Nur Zahirah', 'geoPoint': {'lat': 5.3302, 'lon': 103.1408}}, {'zip': '1000', 'city': 'Skopje', 'country': 'North Macedonia', 'facility': "PHI University Clinic for Children's Diseases Skopje", 'geoPoint': {'lat': 41.99646, 'lon': 21.43141}}, {'zip': '0372', 'city': 'Oslo', 'country': 'Norway', 'facility': 'Klinisk forskningspost', 'geoPoint': {'lat': 59.91273, 'lon': 10.74609}}, {'zip': '50-556', 'city': 'Wroclaw', 'state': 'Lower Silesian Voivodeship', 'country': 'Poland', 'facility': 'Uniwersytecki Szpital Kliniczny im. J.Mikulicza-Radeckiego', 'geoPoint': {'lat': 51.10286, 'lon': 17.03006}}, {'zip': '80-952', 'city': 'Gdansk', 'country': 'Poland', 'facility': 'Uniwersyteckie Centrum Kliniczne', 'geoPoint': {'lat': 54.35227, 'lon': 18.64912}}, {'zip': '20-093', 'city': 'Lublin', 'country': 'Poland', 'facility': 'Uniwersytecki Szpital Dzieciecy, Dzial Krwiolecznictwa', 'geoPoint': {'lat': 51.25058, 'lon': 22.57009}}, {'zip': '02-091', 'city': 'Warsaw', 'country': 'Poland', 'facility': 'Uniwersyteckie Centrum Kliniczne WUM', 'geoPoint': {'lat': 52.22977, 'lon': 21.01178}}, {'zip': '022328', 'city': 'Bucharest', 'country': 'Romania', 'facility': 'Clinic of Haematology, Fundeni Clinical Institute', 'geoPoint': {'lat': 44.43225, 'lon': 26.10626}}, {'zip': '400177', 'city': 'Cluj-Napoca', 'country': 'Romania', 'facility': 'Spitalul Clinic de Urgenta pentru Copii Cluj Napoca', 'geoPoint': {'lat': 46.76667, 'lon': 23.6}}, {'zip': '410469', 'city': 'Oradea', 'country': 'Romania', 'facility': 'Spitalul Clinic Judetean De Urgenta Bihor', 'geoPoint': {'lat': 47.0458, 'lon': 21.91833}}, {'zip': '2193', 'city': 'Parktown, Johannesburg', 'state': 'Gauteng', 'country': 'South Africa', 'facility': 'Charlotte Maxeke Johannesburg Academic Hospital'}, {'zip': '30120', 'city': 'El Palmar', 'state': 'Murcia', 'country': 'Spain', 'facility': 'Hospital Virgen de la Arrixaca - Hematología', 'geoPoint': {'lat': 37.93939, 'lon': -1.16095}}, {'zip': '08035', 'city': 'Barcelona', 'country': 'Spain', 'facility': "Hospital Vall d'Hebron", 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'zip': '28046', 'city': 'Madrid', 'country': 'Spain', 'facility': 'Hospital Universitario La Paz', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '29009', 'city': 'Málaga', 'country': 'Spain', 'facility': 'Hospital Regional Universitario de Málaga', 'geoPoint': {'lat': 36.72016, 'lon': -4.42034}}, {'zip': '413 46', 'city': 'Gothenburg', 'country': 'Sweden', 'facility': 'Koagulationscentrum', 'geoPoint': {'lat': 57.70716, 'lon': 11.96679}}, {'zip': '34000', 'city': 'Ubon Ratchathani', 'state': 'Mueang Distirct,', 'country': 'Thailand', 'facility': 'Sunpasitthiprasong Hospital', 'geoPoint': {'lat': 15.23844, 'lon': 104.84866}}, {'zip': '10330', 'city': 'Bangkok', 'country': 'Thailand', 'facility': 'King Chulalongkorn Memorial Hospital - Pediatric Hematology-Oncology', 'geoPoint': {'lat': 13.75398, 'lon': 100.50144}}, {'zip': '10330', 'city': 'Bangkok', 'country': 'Thailand', 'facility': 'King Chulalongkorn Memorial Hospital_Bangkok_0', 'geoPoint': {'lat': 13.75398, 'lon': 100.50144}}, {'zip': '10400', 'city': 'Bangkok', 'country': 'Thailand', 'facility': 'Ramathibodi Hospital', 'geoPoint': {'lat': 13.75398, 'lon': 100.50144}}, {'zip': '10700', 'city': 'Bangkok', 'country': 'Thailand', 'facility': 'Siriraj Hospital - Hematology and Oncology', 'geoPoint': {'lat': 13.75398, 'lon': 100.50144}}, {'zip': '06500', 'city': 'Ankara', 'state': 'Beşevler/Ankara', 'country': 'Turkey (Türkiye)', 'facility': 'Gazi University', 'geoPoint': {'lat': 39.91987, 'lon': 32.85427}}, {'zip': '06500', 'city': 'Ankara', 'state': 'Beşevler/Ankara', 'country': 'Turkey (Türkiye)', 'facility': 'Gazi Üniversitesi Hastanesi- Hematoloji', 'geoPoint': {'lat': 39.91987, 'lon': 32.85427}}, {'zip': '01130', 'city': 'Adana', 'country': 'Turkey (Türkiye)', 'facility': 'Acibadem Adana Hastanesi', 'geoPoint': {'lat': 36.98615, 'lon': 35.32531}}, {'zip': '01130', 'city': 'Adana', 'country': 'Turkey (Türkiye)', 'facility': 'Acıbadem Adana Hastanesi-Hematoloji', 'geoPoint': {'lat': 36.98615, 'lon': 35.32531}}, {'zip': '35100', 'city': 'Izmir', 'country': 'Turkey (Türkiye)', 'facility': 'Ege Universitesi Tip Fakultesi', 'geoPoint': {'lat': 38.41273, 'lon': 27.13838}}, {'zip': '35100', 'city': 'Izmir', 'country': 'Turkey (Türkiye)', 'facility': 'Ege Üniversitesi Hastanesi- Hematoloji', 'geoPoint': {'lat': 38.41273, 'lon': 27.13838}}, {'zip': '55139', 'city': 'Samsun', 'country': 'Turkey (Türkiye)', 'facility': 'Ondokuz Mayis University Medical Faculty Ped. Haematology', 'geoPoint': {'lat': 41.27976, 'lon': 36.3361}}, {'zip': 'B4 6NH', 'city': 'Birmingham', 'country': 'United Kingdom', 'facility': "Birmingham Children's Hospital", 'geoPoint': {'lat': 52.48142, 'lon': -1.89983}}, {'zip': 'BS2 8BJ', 'city': 'Bristol', 'country': 'United Kingdom', 'facility': 'University Hospitals Bristol & Weston NHS Foundation Trust', 'geoPoint': {'lat': 51.45523, 'lon': -2.59665}}, {'zip': 'SE1 7EH', 'city': 'London', 'country': 'United Kingdom', 'facility': "Evelina London Children's Hospital", 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'zip': 'WC1N 3HR', 'city': 'London', 'country': 'United Kingdom', 'facility': 'Great Ormond Street Hospital for Children', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}], 'overallOfficials': [{'name': 'Clinical Transparency (dept. 2834)', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Novo Nordisk A/S'}]}, 'ipdSharingStatementModule': {'url': 'http://novonordisk-trials.com', 'ipdSharing': 'YES', 'description': 'According to the Novo Nordisk disclosure commitment on novonordisk-trials.com'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Novo Nordisk A/S', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}