Ignite Creation Date:
2025-12-24 @ 3:27 PM
Ignite Modification Date:
2026-01-02 @ 8:22 AM
Study NCT ID:
NCT05580692
Status:
TERMINATED
Last Update Posted:
2024-08-19
First Post:
2022-09-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Prospective Study Evaluating Seroprevalence and Seroconversion of Antibodies Against Adeno-associated Virus (AAV)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, '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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 321}}, 'statusModule': {'whyStopped': 'Sponsor decision to terminate; sufficient sample size for statistical analysis has been achieved.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2023-03-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2024-07-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-08-15', 'studyFirstSubmitDate': '2022-09-16', 'studyFirstSubmitQcDate': '2022-10-11', 'lastUpdatePostDateStruct': {'date': '2024-08-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-10-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-07-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To qunatify Seroprevalence of antibodies to selected AAV serotypes', 'timeFrame': '52 weeks', 'description': 'Number of patients with detectable antibodies to selected AAV serotypes'}], 'secondaryOutcomes': [{'measure': 'To describe and characterize selected AAV serotypes antibody responses in adult subjects with Hemophilia A', 'timeFrame': '52 weeks', 'description': 'Antibody titer levels measured in target population to selected AAV serotypes'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hemophilia A']}, 'descriptionModule': {'briefSummary': 'A prospective cohort study utilizing biospecimen sample collection from adult Hemophilia A subjects to evaluate and characterize seroprevalence and the seroconversion of antibodies against AAV serotypes', 'detailedDescription': 'This is a multinational, multi-center, prospective cohort study utilizing biospecimen sample collection from adult Hemophilia A subjects to evaluate and characterize seroprevalence and the seroconversion of antibodies against AAV serotypes'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult Subjects with Hemophilia A\n\nExclusion Criteria:\n\n* Subject previously treated with AAV vector gene therapy'}, 'identificationModule': {'nctId': 'NCT05580692', 'briefTitle': 'A Prospective Study Evaluating Seroprevalence and Seroconversion of Antibodies Against Adeno-associated Virus (AAV)', 'organization': {'class': 'INDUSTRY', 'fullName': 'BioMarin Pharmaceutical'}, 'officialTitle': 'A Multinational, Multi-center, Prospective Cohort Study Evaluating Seroprevalence and Seroconversion of Antibodies Against Adeno-associated Virus (AAV) Serotypes in Subjects With Hemophilia A', 'orgStudyIdInfo': {'id': '270-702'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Patient Cohort', 'description': 'All Patients are within the same arm', 'interventionNames': ['Procedure: Biospecimen Collection']}], 'interventions': [{'name': 'Biospecimen Collection', 'type': 'PROCEDURE', 'description': 'Biospecimen Sample Collection', 'armGroupLabels': ['Patient Cohort']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'M5504FKD', 'city': 'Godoy Cruz', 'state': 'Mendoza Province', 'country': 'Argentina', 'facility': 'Instituto Hematologia Arbesu', 'geoPoint': {'lat': -32.92533, 'lon': -68.84428}}, {'zip': 'W3410 FND', 'city': 'Corrientes', 'country': 'Argentina', 'facility': 'Hospital Ramon Jose Vidal', 'geoPoint': {'lat': -27.46784, 'lon': -58.8344}}, {'city': 'Mendoza', 'country': 'Argentina', 'facility': 'Medico Hematologo', 'geoPoint': {'lat': -32.88946, 'lon': -68.84582}}, {'zip': 'S2000 CFK', 'city': 'Rosario', 'country': 'Argentina', 'facility': 'Instituto de Hematologia y Medicina Clinica Dr. RUben Davoli', 'geoPoint': {'lat': -32.94682, 'lon': -60.63932}}, {'zip': '2050', 'city': 'Camperdown', 'country': 'Australia', 'facility': 'Royal Prince Alfred Hospital', 'geoPoint': {'lat': -33.88965, 'lon': 151.17642}}, {'zip': '6150', 'city': 'Murdoch', 'country': 'Australia', 'facility': 'Haemophilia and Haemostasis Centre Level 1 Cancer Centre South Metropolitan Health Service Fiona Stanley Hospital', 'geoPoint': {'lat': -32.06987, 'lon': 115.83757}}, {'zip': '1090', 'city': 'Vienna', 'country': 'Austria', 'facility': 'Medical University of Vienna', 'geoPoint': {'lat': 48.20849, 'lon': 16.37208}}, {'zip': '11211', 'city': 'Riyadh', 'country': 'Saudi Arabia', 'facility': 'King Faisal Specialist Hospital & Research Center', 'geoPoint': {'lat': 24.68773, 'lon': 46.72185}}, {'zip': '12372', 'city': 'Riyadh', 'country': 'Saudi Arabia', 'facility': 'King Saud University Medical City King Saud University', 'geoPoint': {'lat': 24.68773, 'lon': 46.72185}}, {'zip': '205 02', 'city': 'Malmo', 'country': 'Sweden', 'facility': 'Skane University Hospital', 'geoPoint': {'lat': 55.60587, 'lon': 13.00073}}, {'zip': 'SE-171 76', 'city': 'Solna', 'country': 'Sweden', 'facility': 'ME Centrum för kliniska cancerstudier - House H3', 'geoPoint': {'lat': 59.36004, 'lon': 18.00086}}, {'zip': '01130', 'city': 'Adana', 'country': 'Turkey (Türkiye)', 'facility': 'Acibadem Adana Hospital', 'geoPoint': {'lat': 36.98615, 'lon': 35.32531}}, {'zip': '06100', 'city': 'Ankara', 'country': 'Turkey (Türkiye)', 'facility': 'Hacettepe University', 'geoPoint': {'lat': 39.91987, 'lon': 32.85427}}, {'zip': '27310', 'city': 'Gaziantep', 'country': 'Turkey (Türkiye)', 'facility': 'Gaziantep University Medical Faculty Sahinbey Educational Research Hospital', 'geoPoint': {'lat': 37.05944, 'lon': 37.3825}}, {'zip': '34098', 'city': 'Istanbul', 'country': 'Turkey (Türkiye)', 'facility': 'Istanbul University Cerrahpasa - Cerrahpasa Medical Faculty', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}, {'zip': '35040', 'city': 'Izmir', 'country': 'Turkey (Türkiye)', 'facility': 'Ege University Medical Faculty', 'geoPoint': {'lat': 38.41273, 'lon': 27.13838}}, {'zip': '55270', 'city': 'Samsun', 'country': 'Turkey (Türkiye)', 'facility': 'Ondokuz Mayis Univ. Med. Fac.', 'geoPoint': {'lat': 41.27976, 'lon': 36.3361}}, {'zip': '11393', 'city': 'Abu Dhabi', 'country': 'United Arab Emirates', 'facility': 'Sheikh Shakhbout Medical City', 'geoPoint': {'lat': 24.45118, 'lon': 54.39696}}], 'overallOfficials': [{'name': 'Medinfo Medinfo', 'role': 'STUDY_DIRECTOR', 'affiliation': 'BioMarin Pharmaceutical'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'BioMarin Pharmaceutical', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}