Ignite Creation Date:
2025-12-26 @ 10:58 AM
Ignite Modification Date:
2025-12-29 @ 2:39 PM
Study NCT ID:
NCT00945906
Status:
COMPLETED
Last Update Posted:
2012-10-12
First Post:
2009-07-23
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
An Open Enrollment Study of Factor XIII Concentrate in Subjects With Congenital Factor XIII Deficiency
Sponsor:
Organization:
Raw JSON
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CSL supports the publication of results from all centers of a multi-center trial and generally requires that reports based on single-site data not precede the primary publication of the entire clinical trial.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'After the first infusion until study completion. Study completion is up to 2 years or until Factor XIII Concentrate (Human) is commercially available in the USA.', 'description': 'The Safety Population consisted of all subjects who received a dose of Factor XIII Concentrate (Human) during the study.', 'eventGroups': [{'id': 'EG000', 'title': 'FXIII', 'description': 'Subjects were administered FXIII Concentrate (Human) by intravenous (IV) infusion approximately every 28 days to maintain a trough FXIII level of approximately 5 to 20%.', 'otherNumAtRisk': 61, 'otherNumAffected': 19, 'seriousNumAtRisk': 61, 'seriousNumAffected': 2}], 'otherEvents': [{'term': 'Upper respiratory infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numEvents': 5, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Fever', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numEvents': 7, 'numAffected': 6}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Bruising', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numEvents': 5, 'numAffected': 4}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numEvents': 4, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}], 'seriousEvents': [{'term': 'Factor XIII inhibition', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Pelvic inflammatory disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Pyelonephritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Fever', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}], 'frequencyThreshold': '4'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'FXIII', 'description': 'Subjects were administered FXIII Concentrate (Human) by intravenous (IV) infusion approximately every 28 days to maintain a trough FXIII level of approximately 5 to 20%.'}], 'classes': [{'title': 'Any treatment-emergent AE', 'categories': [{'measurements': [{'value': '42', 'groupId': 'OG000'}]}]}, {'title': 'Treatment-emergent and related AE', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Serious AE', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'After the first infusion until study completion. Study completion is up to 2 years or until Factor XIII Concentrate (Human) is commercially available in the USA.', 'description': 'Number of subjects with any treatment-emergent adverse event (AE), treatment-related AE or serious AE (SAE). Treatment-related AEs are defined as AEs whose relationship to treatment is related, or possibly related and AEs with missing relationship.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The Safety Population consisted of all subjects who received a dose of Factor XIII Concentrate (Human) during the study. Treatment related AEs are events whose relationship to study treatment is related, or possibly related, in the opinion of the investigator. AEs with missing relationship are considered related to treatment.'}, {'type': 'SECONDARY', 'title': 'Hematology and Chemistry Testing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'FXIII', 'description': 'Subjects were administered FXIII Concentrate (Human) by intravenous (IV) infusion approximately every 28 days to maintain a trough FXIII level of approximately 5 to 20%.'}], 'classes': [{'title': 'Clinically significant hematology test result', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Clinically significant chemistry test result', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'After the first infusion and at the end-of-study (or withdrawal) visit.', 'description': 'Number of participants with treatment-emergent clinically significant hematology and/or chemistry laboratory parameter values.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The Safety Population consisted of all subjects who received a dose of Factor XIII Concentrate (Human) during the study.'}, {'type': 'SECONDARY', 'title': 'FXIII Antibody Testing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'FXIII', 'description': 'Subjects were administered FXIII Concentrate (Human) by intravenous (IV) infusion approximately every 28 days to maintain a trough FXIII level of approximately 5 to 20%.'}], 'classes': [{'title': 'Subjects with Factor XIII antibodies', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Subjects without Factor XIII antibodies', 'categories': [{'measurements': [{'value': '60', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Before the first infusion, then every 48 weeks, at the end-of-study (or withdrawal) visit and after a bleeding episode requiring treatment with a Factor XIII -containing product.', 'description': 'Number of participants with serum Factor XIII antibodies.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The Safety Population consisted of all subjects who received a dose of Factor XIII Concentrate (Human) during the study.'}, {'type': 'SECONDARY', 'title': 'FXIII Concentration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'FXIII', 'description': 'Subjects were administered FXIII Concentrate (Human) by intravenous (IV) infusion approximately every 28 days to maintain a trough FXIII level of approximately 5 to 20%.'}], 'classes': [{'title': 'Baseline (n = 35)', 'categories': [{'measurements': [{'value': '0.0987', 'spread': '0.03695', 'groupId': 'OG000'}]}]}, {'title': 'Week 4 (n = 28)', 'categories': [{'measurements': [{'value': '0.1177', 'spread': '0.03484', 'groupId': 'OG000'}]}]}, {'title': 'Week 8 (n = 8)', 'categories': [{'measurements': [{'value': '0.1238', 'spread': '0.02973', 'groupId': 'OG000'}]}]}, {'title': 'Week 12 (n = 8)', 'categories': [{'measurements': [{'value': '0.1075', 'spread': '0.03196', 'groupId': 'OG000'}]}]}, {'title': 'Week 16 (n = 4)', 'categories': [{'measurements': [{'value': '0.1025', 'spread': '0.04573', 'groupId': 'OG000'}]}]}, {'title': 'Week 20 (n = 5)', 'categories': [{'measurements': [{'value': '0.1160', 'spread': '0.03578', 'groupId': 'OG000'}]}]}, {'title': 'Week 24 (n = 41)', 'categories': [{'measurements': [{'value': '0.1341', 'spread': '0.03346', 'groupId': 'OG000'}]}]}, {'title': 'Week 28 (n = 3)', 'categories': [{'measurements': [{'value': '0.1667', 'spread': '0.06658', 'groupId': 'OG000'}]}]}, {'title': 'Week 32 (n = 2)', 'categories': [{'measurements': [{'value': '0.0950', 'spread': '0.02121', 'groupId': 'OG000'}]}]}, {'title': 'Week 36 (n = 3)', 'categories': [{'measurements': [{'value': '0.1083', 'spread': '0.07489', 'groupId': 'OG000'}]}]}, {'title': 'Week 40 (n = 3)', 'categories': [{'measurements': [{'value': '0.0933', 'spread': '0.04509', 'groupId': 'OG000'}]}]}, {'title': 'Week 44 (n = 1)', 'categories': [{'measurements': [{'value': '0.0500', 'spread': '0', 'groupId': 'OG000'}]}]}, {'title': 'Week 48 (n = 13)', 'categories': [{'measurements': [{'value': '0.1246', 'spread': '0.02961', 'groupId': 'OG000'}]}]}, {'title': 'Week 72 (n = 2)', 'categories': [{'measurements': [{'value': '0.1400', 'spread': '0.01414', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Before the first infusion, at 24 and 48 weeks after the first infusion, and at the end-of-study (or withdrawal) visit.', 'description': 'Trough Factor XIII concentration.', 'unitOfMeasure': 'Units/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The Safety Population consisted of all subjects who received a dose of Factor XIII Concentrate (Human) during the study.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With at Least One Bleeding Episode', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'FXIII', 'description': 'Subjects were administered FXIII Concentrate (Human) by intravenous (IV) infusion approximately every 28 days to maintain a trough FXIII level of approximately 5 to 20%.'}], 'classes': [{'title': 'At least one bleeding episode (after treatment)', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}]}]}, {'title': 'At least one bleeding episode requiring treatment', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'After the first infusion until study completion. Study completion is up to 2 years or until Factor XIII Concentrate (Human) is commercially available in the USA.', 'description': 'Number of subjects with at least one bleeding episode at any time after the first infusion in the study, and the number of subjects with at least one bleeding episode requiring Factor XIII treatment.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The Safety Population consisted of all subjects who received a dose of Factor XIII Concentrate (Human) during the study.'}, {'type': 'SECONDARY', 'title': 'Number of Bleeding Episodes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'FXIII', 'description': 'Subjects were administered FXIII Concentrate (Human) by intravenous (IV) infusion approximately every 28 days to maintain a trough FXIII level of approximately 5 to 20%.'}], 'classes': [{'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'After the first infusion until study completion. Study completion is up to 2 years or until Factor XIII Concentrate (Human) is commercially available in the USA.', 'description': 'Number of bleeding episodes at any time after the first infusion in the study.', 'unitOfMeasure': 'Episodes', 'reportingStatus': 'POSTED', 'populationDescription': 'The Safety Population consisted of all subjects who received a dose of Factor XIII Concentrate (Human) during the study.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'FXIII', 'description': 'Subjects were administered FXIII Concentrate (Human) by intravenous (IV) infusion approximately every 28 days to maintain a trough FXIII level of approximately 5 to 20%.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '61'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '54'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Did not want to return for last visit', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}]}, {'type': 'Unable to return for last visit', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}]}, {'type': 'Moved to another country', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'FXIII', 'description': 'Subjects were administered FXIII Concentrate (Human) by intravenous (IV) infusion approximately every 28 days to maintain a trough FXIII level of approximately 5 to 20%.'}], 'measures': [{'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '18.5', 'spread': '12.48', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Age, Customized', 'classes': [{'title': '< 16 years', 'categories': [{'measurements': [{'value': '29', 'groupId': 'BG000'}]}]}, {'title': '16 to < 65 years', 'categories': [{'measurements': [{'value': '32', 'groupId': 'BG000'}]}]}, {'title': '>=65 years', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '26', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '35', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 61}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-09', 'completionDateStruct': {'date': '2011-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-09-12', 'studyFirstSubmitDate': '2009-07-23', 'resultsFirstSubmitDate': '2012-09-12', 'studyFirstSubmitQcDate': '2009-07-23', 'lastUpdatePostDateStruct': {'date': '2012-10-12', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2012-09-12', 'studyFirstPostDateStruct': {'date': '2009-07-24', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2012-10-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Adverse Events', 'timeFrame': 'After the first infusion until study completion. Study completion is up to 2 years or until Factor XIII Concentrate (Human) is commercially available in the USA.', 'description': 'Number of subjects with any treatment-emergent adverse event (AE), treatment-related AE or serious AE (SAE). Treatment-related AEs are defined as AEs whose relationship to treatment is related, or possibly related and AEs with missing relationship.'}], 'secondaryOutcomes': [{'measure': 'Hematology and Chemistry Testing', 'timeFrame': 'After the first infusion and at the end-of-study (or withdrawal) visit.', 'description': 'Number of participants with treatment-emergent clinically significant hematology and/or chemistry laboratory parameter values.'}, {'measure': 'FXIII Antibody Testing', 'timeFrame': 'Before the first infusion, then every 48 weeks, at the end-of-study (or withdrawal) visit and after a bleeding episode requiring treatment with a Factor XIII -containing product.', 'description': 'Number of participants with serum Factor XIII antibodies.'}, {'measure': 'FXIII Concentration', 'timeFrame': 'Before the first infusion, at 24 and 48 weeks after the first infusion, and at the end-of-study (or withdrawal) visit.', 'description': 'Trough Factor XIII concentration.'}, {'measure': 'Number of Subjects With at Least One Bleeding Episode', 'timeFrame': 'After the first infusion until study completion. Study completion is up to 2 years or until Factor XIII Concentrate (Human) is commercially available in the USA.', 'description': 'Number of subjects with at least one bleeding episode at any time after the first infusion in the study, and the number of subjects with at least one bleeding episode requiring Factor XIII treatment.'}, {'measure': 'Number of Bleeding Episodes', 'timeFrame': 'After the first infusion until study completion. Study completion is up to 2 years or until Factor XIII Concentrate (Human) is commercially available in the USA.', 'description': 'Number of bleeding episodes at any time after the first infusion in the study.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Hereditary Factor XIII deficiency', 'Factor XIII'], 'conditions': ['Factor XIII Deficiency']}, 'descriptionModule': {'briefSummary': 'Congenital deficiency of factor XIII is an extremely rare inherited disorder associated with potentially life-threatening bleeding. Factor XIII Concentrate is given to patients whose blood is lacking factor XIII. Factor XIII Concentrate works by assisting blood in the usual clotting process, thereby preventing bleeding.\n\nIn this study, patients will be treated with FXIII Concentrate (Human) and followed closely to determine that they receive the dose of FXIII Concentrate (Human) that will best minimize the chance of bruising and bleeding. The purpose of the study is to provide FXIII Concentrate (Human) to patients until the product becomes commercially available in the United States.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Written informed consent/assent for study participation obtained before undergoing any study specific procedures\n* Diagnosed with congenital FXIII deficiency requiring prophylactic treatment\n* Males and females of any age\n\nExclusion Criteria:\n\n* Diagnosis of acquired FXIII deficiency\n* Administration of a FXIII-containing product, including blood transfusions or other blood products, within 3 weeks prior to the Baseline/Day 0 Visit\n* Any known congenital or acquired coagulation disorder other than congenital FXIII deficiency\n* Use of any other IMP within 4 weeks prior to Baseline/Day 0 Visit\n* Female subjects of childbearing potential not using, or not willing to use, a medically reliable method of contraception for the entire duration of the study\n* Suspected inability (e.g., language problems) or unwillingness to comply with study procedures or history of noncompliance\n* Any laboratory finding or medical condition which, in the opinion of the Investigator, would put the subject or subject's disease management at risk"}, 'identificationModule': {'nctId': 'NCT00945906', 'briefTitle': 'An Open Enrollment Study of Factor XIII Concentrate in Subjects With Congenital Factor XIII Deficiency', 'organization': {'class': 'INDUSTRY', 'fullName': 'CSL Behring'}, 'officialTitle': 'A Prospective, Multicenter, Open Enrollment Study of Human Plasma-Derived Factor XIII Concentrate in Subjects With Congenital Factor XIII Deficiency', 'orgStudyIdInfo': {'id': 'BI71023_3002'}, 'secondaryIdInfos': [{'id': '1488', 'type': 'OTHER', 'domain': 'CSL Behring'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'FXIII', 'description': 'Subjects were administered FXIII Concentrate (Human) by intravenous (IV) infusion approximately every 28 days to maintain a trough FXIII level of approximately 5 to 20%.', 'interventionNames': ['Biological: FXIII Concentrate (Human) (FXIII)']}], 'interventions': [{'name': 'FXIII Concentrate (Human) (FXIII)', 'type': 'BIOLOGICAL', 'otherNames': ['Fibrogammin-P®', 'Corifact®'], 'description': "Doses will be guided by the individual subject's most recent FXIII activity levels, with the objective of dosing every 28 days to maintain a trough FXIII activity level of approximately 5 to 20%.\n\nSubjects enrolled in this study who have not received at least 3 doses of FXIII Concentrate in a previous study of this product (i.e., NCT00640289, NCT00885742, or NCT00883090) will initially receive a dose of 40 U/kg by intravenous (IV) infusion.", 'armGroupLabels': ['FXIII']}]}, 'contactsLocationsModule': {'locations': [{'zip': '36301', 'city': 'Dothan', 'state': 'Alabama', 'country': 'United States', 'facility': 'Study Site', 'geoPoint': {'lat': 31.22323, 'lon': -85.39049}}, {'zip': '94609', 'city': 'Oakland', 'state': 'California', 'country': 'United States', 'facility': 'Study Site', 'geoPoint': {'lat': 37.80437, 'lon': -122.2708}}, {'zip': '92868', 'city': 'Orange', 'state': 'California', 'country': 'United States', 'facility': 'Study Site', 'geoPoint': {'lat': 33.78779, 'lon': -117.85311}}, {'zip': '94118', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'Study Site', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '95204', 'city': 'Stockton', 'state': 'California', 'country': 'United States', 'facility': 'Study Site', 'geoPoint': {'lat': 37.9577, 'lon': -121.29078}}, {'zip': '33908', 'city': 'Fort Myers', 'state': 'Florida', 'country': 'United States', 'facility': 'Study Site', 'geoPoint': {'lat': 26.62168, 'lon': -81.84059}}, {'zip': '33136', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Study 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-87.90647}}], 'overallOfficials': [{'name': 'Program Director, Clinical R&D', 'role': 'STUDY_DIRECTOR', 'affiliation': 'CSL Behring'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'CSL Behring', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}