Ignite Creation Date:
2025-12-25 @ 5:02 AM
Ignite Modification Date:
2025-12-26 @ 4:03 AM
Study NCT ID:
NCT06948318
Status:
RECRUITING
Last Update Posted:
2025-12-18
First Post:
2025-04-25
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Continuation Study of Mezagitamab in Adults With Chronic Primary Immune Thrombocytopenia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016553', 'term': 'Purpura, Thrombocytopenic, Idiopathic'}, {'id': 'D001791', 'term': 'Blood Platelet Disorders'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D000095542', 'term': 'Cytopenia'}, {'id': 'D011693', 'term': 'Purpura'}, {'id': 'D006474', 'term': 'Hemorrhagic Disorders'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D006470', 'term': 'Hemorrhage'}, {'id': 'D012877', 'term': 'Skin Manifestations'}, {'id': 'D011696', 'term': 'Purpura, Thrombocytopenic'}], 'ancestors': [{'id': 'D001778', 'term': 'Blood Coagulation Disorders'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D057049', 'term': 'Thrombotic Microangiopathies'}, {'id': 'D013921', 'term': 'Thrombocytopenia'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 150}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-08-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2029-07-29', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-16', 'studyFirstSubmitDate': '2025-04-25', 'studyFirstSubmitQcDate': '2025-04-28', 'lastUpdatePostDateStruct': {'date': '2025-12-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-04-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2029-07-29', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious TEAEs', 'timeFrame': 'Up to approximately 108 weeks', 'description': 'An adverse event (AE) is any untoward medical occurrence in a clinical trial participant, temporally associated with the use of the trial intervention, whether or not the occurrence is considered related to the trial intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of the trial intervention. TEAEs are defined as AEs with start dates at the time of or following the first exposure to mezagitamab in the parent trial for Cohort 1 and in this trial for Cohort 2. A serious TEAE is a TEAE that meets 1 or more of the criteria: results in death, is life threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or was otherwise considered medically important.'}, {'measure': 'Number of Participants With TEAEs Leading to Permanent Withdrawal of Mezagitamab', 'timeFrame': 'Up to approximately 108 weeks', 'description': 'An AE is any untoward medical occurrence in a clinical trial participant, temporally associated with the use of the trial intervention, whether or not the occurrence is considered related to the trial intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of the trial intervention. TEAEs are defined as AEs with start dates at the time of or following the first exposure to mezagitamab in the parent trial for Cohort 1 and in this trial for Cohort 2.'}], 'secondaryOutcomes': [{'measure': 'Duration of Platelet Response', 'timeFrame': 'Up to approximately 108 weeks', 'description': 'The duration of platelet response will be measured by the cumulative number of weeks on which platelet count was ≥30,000/microliters (μL) and ≥50,000/μL throughout the trial.'}, {'measure': 'Duration Between On-Demand Treatment Courses', 'timeFrame': 'Up to approximately 108 weeks'}, {'measure': 'Time to Initiation of the First On-Demand Treatment Course', 'timeFrame': 'Up to approximately 108 weeks'}, {'measure': 'Number of Participants With Complete Response', 'timeFrame': 'Up to approximately 108 weeks', 'description': 'Complete response is defined as achieving platelet counts ≥100,000/μL on at least 2 visits.'}, {'measure': 'Number of Participants With Immune Thrombocytopenia (ITP) Remission', 'timeFrame': 'Up to approximately 108 weeks', 'description': 'ITP Remission is defined as all platelet counts ≥50,000/μL for at least 24 weeks after any mezagitamab treatment cycle in the absence of further therapy for ITP.'}, {'measure': 'Number of Participants With Reduction in Dose and/or Frequency of Concomitant ITP Medications', 'timeFrame': 'Up to approximately 108 weeks', 'description': 'Concomitant ITP medications are defined as those given in addition to the trial intervention to treat your ITP. These medications include corticosteroids, thrombopoietin receptor agonists (TPO-RA), or fostamatinib.'}, {'measure': 'Number of Participants Requiring Rescue Therapy', 'timeFrame': 'Up to approximately 108 weeks'}, {'measure': 'Serum Concentrations of Mezagitamab', 'timeFrame': 'Pre-dose and at multiple time points post-dose up to Week 104'}, {'measure': 'Number of Participants With Anti-Drug Antibodies (ADA)', 'timeFrame': 'Pre-dose and at multiple time points post-dose up to Week 104'}, {'measure': 'Number of Participants With Neutralizing Antibody (NAb)', 'timeFrame': 'Pre-dose and at multiple time points post-dose up to Week 104'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['TAK-079', 'Immune Thrombocytopenia', 'Chronic Primary Immune Thrombocytopenia', 'Blood Platelet Disorders', 'Hematologic Diseases', 'Cytopenia', 'Purpura', 'Hemorrhagic Disorders', 'Autoimmune Diseases', 'Immune System Diseases', 'Hemorrhage', 'Skin Manifestations', 'Purpura, Thrombocytopenic, Idiopathic', 'Purpura, Thrombocytopenic'], 'conditions': ['Immune Thrombocytopenic Purpura (ITP)']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://clinicaltrials.takeda.com/study-detail/a3da95a29a994831??page=1&idFilter=TAK-079-3003', 'label': 'Click here for more information about this trial in easy-to-understand language, including a Plain Language Summary of the results if the trial has been completed.'}]}, 'descriptionModule': {'briefSummary': 'Primary immune thrombocytopenia (ITP) is a condition where the immune system mistakenly destroys platelets, which are cells that help stop bleeding. This leads to a lower number of platelets, making it easier to bruise or bleed. The main aim of this study is to check how safe mezagitamab is and how well it is tolerated by adults with chronic primary ITP, if given over a longer time. Other aims are to learn how effective treatment with mezagitamab is and how the body processes it (called pharmacokinetics or PK) over a longer time.\n\nParticipants of the following previous mezagitamab studies will be invited to join this continuation study: TAK-079-3002 and TAK-079-1004. In this continuation study, participants will receive mezagitamab when certain protocol criteria are met.\n\nDuring the study, participants will visit their study clinic several times.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': '* Key Inclusion Criteria:\n\n 1\\. The participant has completed TAK-079-3002 (end of trial \\[EOT\\]) or TAK-079-1004 (EOT).\n* Key Exclusion criteria:\n\nFor TAK-079-3002 participants:\n\n1\\. The participant has a history of severe allergic or anaphylactic reactions to recombinant proteins or excipients used in the mezagitamab formulation.\n\nFor TAK-079-1004 participants:\n\n1. The participant has had any thrombotic or embolic event within 12 months before signing the ICF.\n2. The participant has had a splenectomy within 3 months before signing the ICF.\n3. The participant has active infection with hepatitis B virus (HBV), hepatitis C virus (HCV), or human immunodeficiency virus (HIV).\n4. History of malignancy (including myelodysplastic syndrome) within 5 years of signing the ICF, except for treated non-melanoma skin cancer or cervical carcinoma in situ.\n5. In the opinion of the investigator, the participant has a serious medical or psychiatric illness that could potentially interfere with the completion of treatment according to this protocol.\n6. The participant has received anti-cluster of differentiation (CD) 20 treatment within 12 months before screening and either of the following applies:\n\n 1. The last dose was received within 6 months before screening.\n 2. The last dose was received between 6 and 12 months before screening and the participant has a CD19+ count below the lower limit of normal.\n7. The participant has received any monoclonal or polyclonal antibody for immunomodulation within 6 months before Visit 1.\n8. The participant has been exposed to another investigational agent within 4 weeks or 5 half-lives, whichever is longer, before Visit 1.\n9. The participant has used anticoagulants (for example, vitamin K antagonists, direct oral anticoagulants) within 3 weeks prior to Visit 1.\n\n10 The participant has received a live or live-attenuated vaccine within 4 weeks prior to the first dose of trial treatment or has any live or live-attenuated vaccine planned during the trial.\n\n11\\. The participant has used the following immunosuppressive agents as specified prior to Visit 1: alkylating agents (for example, cyclophosphamide) within 8 weeks, vinca alkaloids (for example, vincristine) within 4 weeks, sulfones (for example, dapsone) within 3 weeks, antiproliferative agents: (for example, mycophenolate mofetil and azathioprine) within 2 weeks, and calcineurin inhibitors: (for example, cyclosporine) within 2 weeks.\n\n12\\. The participant has a history of severe allergic or anaphylactic reactions to recombinant proteins or excipients used in the mezagitamab formulation.\n\nOther protocol defined inclusion/exclusion criteria may apply.'}, 'identificationModule': {'nctId': 'NCT06948318', 'briefTitle': 'A Continuation Study of Mezagitamab in Adults With Chronic Primary Immune Thrombocytopenia', 'organization': {'class': 'INDUSTRY', 'fullName': 'Takeda'}, 'officialTitle': 'A Phase 3, Open-label, Multicenter Continuation Trial to Evaluate the Long-term Safety and Efficacy of Mezagitamab Subcutaneous Injection in Adults With Chronic Primary Immune Thrombocytopenia', 'orgStudyIdInfo': {'id': 'TAK-079-3003'}, 'secondaryIdInfos': [{'id': '2025-521692-31-00', 'type': 'CTIS'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Mezagitamab', 'description': "Eligible participants who completed the TAK-079-3002 or TAK-079-1004 studies can receive on-demand treatment in this continuation study. The on-demand treatment course may be repeated as needed based on the pre-specified on-demand dosing criteria and investigator's clinical judgement.", 'interventionNames': ['Drug: Mezagitamab']}], 'interventions': [{'name': 'Mezagitamab', 'type': 'DRUG', 'otherNames': ['TAK-079'], 'description': 'Mezagitamab injection administered SC.', 'armGroupLabels': ['Mezagitamab']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90033', 'city': 'Los Angeles', 'state': 'California', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Site Contact', 'role': 'CONTACT'}, {'name': 'Howard Liebman', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'USC Norris Comprehensive Cancer Center - Keck Medicine of USC', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '80218', 'city': 'Denver', 'state': 'Colorado', 'status': 'WITHDRAWN', 'country': 'United States', 'facility': 'Rocky Mountain Cancer Center', 'geoPoint': {'lat': 39.73915, 'lon': -104.9847}}, {'zip': '20007', 'city': 'Washington D.C.', 'state': 'District of Columbia', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Site Contact', 'role': 'CONTACT'}, {'name': 'Catherine Broome', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Georgetown University Medical Center - Lombardi Comprehensive Cancer Center', 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}, {'zip': '30308', 'city': 'Atlanta', 'state': 'Georgia', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Site Contact', 'role': 'CONTACT'}, {'name': 'Ana Antun', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Emory University', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '52242', 'city': 'Iowa City', 'state': 'Iowa', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Site Contact', 'role': 'CONTACT'}, {'name': 'Steven Lentz', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'The University of Iowa', 'geoPoint': {'lat': 41.66113, 'lon': -91.53017}}, {'zip': '40202', 'city': 'Louisville', 'state': 'Kentucky', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Site Contact', 'role': 'CONTACT'}, {'name': 'Kamila Cisak', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University Of Louisville Brown Cancer Center', 'geoPoint': {'lat': 38.25424, 'lon': -85.75941}}, {'zip': '02114', 'city': 'Boston', 'state': 'Massachusetts', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Site Contact', 'role': 'CONTACT'}, {'name': 'David Kuter', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Massachusetts General Hospital', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '01655', 'city': 'Worcester', 'state': 'Massachusetts', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Site Contact', 'role': 'CONTACT'}, {'name': 'Daniel Winokur', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of Massachusetts Chan Medical School', 'geoPoint': {'lat': 42.26259, 'lon': -71.80229}}, {'zip': '27710', 'city': 'Durham', 'state': 'North Carolina', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Site Contact', 'role': 'CONTACT'}, {'name': 'Ara Metjian', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Duke University Hospital', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}, {'zip': '27837', 'city': 'Greenville', 'state': 'North Carolina', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Site Contact', 'role': 'CONTACT'}, {'name': 'Darla Liles', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'East Carolina University', 'geoPoint': {'lat': 35.61266, 'lon': -77.36635}}, {'zip': '97239', 'city': 'Portland', 'state': 'Oregon', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Site Contact', 'role': 'CONTACT'}, {'name': 'Joseph Shatzel', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Oregon Health & Science University', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}, {'zip': '19104', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Site Contact', 'role': 'CONTACT'}, {'name': 'Adam Cuker', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Perelman Center for Advanced Medicine (PCAM) Hospital of The University of Pennsylvania Penn Blood Disorders Program', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '19140', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Site Contact', 'role': 'CONTACT'}, {'name': 'Michael Bromberg', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Lewis Katz School of Medicine at Temple University', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Site Contact', 'role': 'CONTACT'}, {'name': 'Senthil Sukumar', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Baylor College of Medicine', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '23502', 'city': 'Norfolk', 'state': 'Virginia', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Site Contact', 'role': 'CONTACT'}, {'name': 'Bremer Celeste', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Virginia Oncology Associates', 'geoPoint': {'lat': 36.84681, 'lon': -76.28522}}, {'zip': '98109', 'city': 'Seattle', 'state': 'Washington', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Site Contact', 'role': 'CONTACT'}, {'name': 'Sandhya Panch', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of Washingto', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}, {'zip': '53226', 'city': 'Milwaukee', 'state': 'Wisconsin', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Site Contact', 'role': 'CONTACT'}, {'name': 'Lisa Kreuziger', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Versiti Wisconsin, Inc', 'geoPoint': {'lat': 43.0389, 'lon': -87.90647}}, {'zip': '2605', 'city': 'Garran', 'state': 'Australian Capital Territory', 'status': 'NOT_YET_RECRUITING', 'country': 'Australia', 'contacts': [{'name': 'Site Contact', 'role': 'CONTACT', 'email': 'phil.choi@act.gov.au', 'phone': '+61251248492'}, {'name': 'Philip Choi', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Canberra Hospital', 'geoPoint': {'lat': -35.34206, 'lon': 149.10846}}, {'zip': '2139', 'city': 'Concord', 'state': 'New South Wales', 'status': 'NOT_YET_RECRUITING', 'country': 'Australia', 'contacts': [{'name': 'Site Contact', 'role': 'CONTACT', 'email': 'vivien.chen@health.nsw.gov.au', 'phone': '+610297676348'}, {'name': 'Vivien Chen', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Concord Repatriation General Hospital', 'geoPoint': {'lat': -33.84722, 'lon': 151.10381}}, {'zip': '2217', 'city': 'Kogarah', 'state': 'New South Wales', 'status': 'RECRUITING', 'country': 'Australia', 'contacts': [{'name': 'Site Contact', 'role': 'CONTACT', 'email': 'amanda.hugman@health.nsw.gov.au', 'phone': '+61 02 9113 3089'}, {'name': 'Amanda Hugman', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'St George Hospital', 'geoPoint': {'lat': -33.9681, 'lon': 151.13564}}, {'zip': '2170', 'city': 'Liverpool', 'state': 'New South Wales', 'status': 'NOT_YET_RECRUITING', 'country': 'Australia', 'contacts': [{'name': 'Site Contact', 'role': 'CONTACT'}, {'name': 'Danny Hsu', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of New South Wales (UNSW) - Liverpool Hospital - Liverpool Cancer Therapy Centre', 'geoPoint': {'lat': -33.91938, 'lon': 150.92588}}, {'zip': '2145', 'city': 'Westmead', 'state': 'New South Wales', 'status': 'RECRUITING', 'country': 'Australia', 'contacts': [{'name': 'Site Contact', 'role': 'CONTACT', 'email': 'Jennifer.curnow@health.nsw.gov.au', 'phone': '+610288905200'}, {'name': 'Jennifer Curnow', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Westmead Hospital', 'geoPoint': {'lat': -33.80383, 'lon': 150.98768}}, {'zip': '3000', 'city': 'Melbourne', 'state': 'Victoria', 'status': 'NOT_YET_RECRUITING', 'country': 'Australia', 'contacts': [{'name': 'Site Contact', 'role': 'CONTACT'}, {'name': 'Isaac Goncalves', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Peter MacCallum Cancer Centre', 'geoPoint': {'lat': -37.814, 'lon': 144.96332}}, {'zip': '3004', 'city': 'Melbourne', 'state': 'Victoria', 'status': 'NOT_YET_RECRUITING', 'country': 'Australia', 'contacts': [{'name': 'Site Contact', 'role': 'CONTACT'}, {'name': 'Zane Kaplan', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Monash University - Australian Centre for Blood Diseases (ACBD)', 'geoPoint': {'lat': -37.814, 'lon': 144.96332}}, {'zip': '3005', 'city': 'Melbourne', 'state': 'Victoria', 'status': 'RECRUITING', 'country': 'Australia', 'contacts': [{'name': 'Site Contact', 'role': 'CONTACT'}, {'name': 'Huyen Tran', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'The Alfred Hospital', 'geoPoint': {'lat': -37.814, 'lon': 144.96332}}, {'zip': '6150', 'city': 'Murdoch', 'state': 'Western Australia', 'status': 'NOT_YET_RECRUITING', 'country': 'Australia', 'contacts': [{'name': 'Site Contact', 'role': 'CONTACT'}, {'name': 'Dominic Pepperell', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Fiona Stanley Hospital', 'geoPoint': {'lat': -32.06987, 'lon': 115.83757}}, {'zip': '6005', 'city': 'West Perth', 'state': 'Western Australia', 'status': 'RECRUITING', 'country': 'Australia', 'contacts': [{'name': 'Site Contact', 'role': 'CONTACT', 'email': 'ross@pbi.org.au', 'phone': '+61892005300'}, {'name': 'Ross Baker', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Perth Blood Institute', 'geoPoint': {'lat': -31.94896, 'lon': 115.84199}}, {'zip': '1606', 'city': 'Sofia', 'state': 'Sofia-Grad', 'status': 'NOT_YET_RECRUITING', 'country': 'Bulgaria', 'contacts': [{'name': 'Site Contact', 'role': 'CONTACT', 'email': 'viktoriia1982@abv.bg', 'phone': '(359) 884-6741 x60'}, {'name': 'Viktoria Barbukova', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Military Medical Academy Multiprofile Hospital for Active Treatment - Sofia', 'geoPoint': {'lat': 42.69751, 'lon': 23.32415}}, {'zip': '4002', 'city': 'Plovdiv', 'status': 'NOT_YET_RECRUITING', 'country': 'Bulgaria', 'contacts': [{'name': 'Site Contact', 'role': 'CONTACT', 'email': 'kasapunarova@yahoo.com', 'phone': '+359887860806'}, {'name': 'Katya Sapunarova', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Medical Center "Fama Medical"', 'geoPoint': {'lat': 42.15387, 'lon': 24.75001}}, {'zip': '1431', 'city': 'Sofia', 'status': 'NOT_YET_RECRUITING', 'country': 'Bulgaria', 'contacts': [{'name': 'Site Contact', 'role': 'CONTACT'}, {'name': 'Atanas Radinoff', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'UMHAT Sv. Ivan Rilski', 'geoPoint': {'lat': 42.69751, 'lon': 23.32415}}, {'zip': '1750', 'city': 'Sofia', 'status': 'NOT_YET_RECRUITING', 'country': 'Bulgaria', 'contacts': [{'name': 'Site Contact', 'role': 'CONTACT', 'email': 'dr.alaikov@gmail.com', 'phone': '+359888627955'}, {'name': 'Tzvetan Alaykov', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'UMHAT SofiaMed, OOD', 'geoPoint': {'lat': 42.69751, 'lon': 23.32415}}, {'zip': '6003', 'city': 'Stara Zagora', 'status': 'NOT_YET_RECRUITING', 'country': 'Bulgaria', 'contacts': [{'name': 'Site Contact', 'role': 'CONTACT'}, {'name': 'Mariya Todorova', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University Multiprofile Hospital for Active Treatment - Prof. Dr. Stoyan Kirkovich AD', 'geoPoint': {'lat': 42.43205, 'lon': 25.64262}}, {'zip': '100730', 'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Site Contact', 'role': 'CONTACT', 'email': 'zhutn@pumch.cn', 'phone': 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