Ignite Creation Date:
2025-12-25 @ 4:23 AM
Ignite Modification Date:
2026-02-26 @ 12:41 AM
Study NCT ID:
NCT01949220
Status:
COMPLETED
Last Update Posted:
2018-08-08
First Post:
2013-09-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Willebrand International Non-interventional Global Surveillance
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014842', 'term': 'von Willebrand Diseases'}], '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': 'D001791', 'term': 'Blood Platelet Disorders'}, {'id': 'D006474', 'term': 'Hemorrhagic Disorders'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 80}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-12', 'completionDateStruct': {'date': '2017-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-08-07', 'studyFirstSubmitDate': '2013-09-10', 'studyFirstSubmitQcDate': '2013-09-19', 'lastUpdatePostDateStruct': {'date': '2018-08-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-09-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Documentation of product consumption data', 'timeFrame': 'at each follow-up visit, up to 24 months', 'description': 'Product consumption (VWF International Units) by analysis of posology, frequency in relation to the severity of bleeding, type of surgery and other clinical situations.'}], 'secondaryOutcomes': [{'measure': 'Collection and analysis of adverse events and VWF immunological safety', 'timeFrame': 'at each follow-up visit, up to 24 months', 'description': 'Adverse event (type, seriousness, severity, frequency, outcome), anti VWF-antibody and anti FVIII-antibody.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Inherited', 'Von Willebrand disease', 'Von Willebrand factor', 'Deficiency', 'safety'], 'conditions': ['Von Willebrand Disease']}, 'descriptionModule': {'briefSummary': 'Collect information about WILLFACT or WILFACTIN in their real life clinical use and identify the therapeutic practices in an international environment.', 'detailedDescription': 'Non-interventional, prospective, non comparative, international, multicentre study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Any patient, whatever their age, with inherited von Willebrand disease', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with inherited von Willebrand disease\n* Patients treated with WILLFACT or WILFACTIN\n* Patient or parent/legal representative who has provided written signed and dated informed consent before any data collection.\n\nExclusion Criteria:\n\n* Patients who usually do not keep injection log up to date, when treated.'}, 'identificationModule': {'nctId': 'NCT01949220', 'briefTitle': 'Willebrand International Non-interventional Global Surveillance', 'organization': {'class': 'INDUSTRY', 'fullName': 'Laboratoire français de Fractionnement et de Biotechnologies'}, 'officialTitle': 'International Post-Marketing Surveillance of Willfact-Wilfactin in Patients With Inherited Von Willebrand Disease.', 'orgStudyIdInfo': {'id': 'WINGS'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Von Willebrand factor deficient patient', 'description': 'Inherited von Willebrand disease'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Antwerp', 'country': 'Belgium', 'facility': 'Hopital des enfants Reine Fabiola', 'geoPoint': {'lat': 51.22047, 'lon': 4.40026}}, {'zip': '2650', 'city': 'Edegem', 'country': 'Belgium', 'facility': 'UZA hopital universitaire', 'geoPoint': {'lat': 51.15662, 'lon': 4.44504}}, {'zip': '625 00', 'city': 'Brno', 'country': 'Czechia', 'facility': 'University Hospital', 'geoPoint': {'lat': 49.19522, 'lon': 16.60796}}, {'city': 'Helsinki', 'country': 'Finland', 'facility': 'University Central Hospital', 'geoPoint': {'lat': 60.16952, 'lon': 24.93545}}, {'city': 'Berlin', 'country': 'Germany', 'facility': 'Charité Universitätsmedizin', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'city': 'Duisburg', 'country': 'Germany', 'facility': 'GZRR Gerinnungszentrum Rhein/ Ruhr', 'geoPoint': {'lat': 51.43247, 'lon': 6.76516}}, {'city': 'Essen', 'country': 'Germany', 'facility': 'Universitatsklinikum', 'geoPoint': {'lat': 51.45657, 'lon': 7.01228}}, {'zip': '60590', 'city': 'Frankfurt', 'country': 'Germany', 'facility': 'Goethe Universitat', 'geoPoint': {'lat': 49.68333, 'lon': 10.53333}}, {'city': 'Hanover', 'country': 'Germany', 'facility': 'Medizinische Hochschule Hannover', 'geoPoint': {'lat': 52.37052, 'lon': 9.73322}}, {'city': 'Hanover', 'country': 'Germany', 'facility': 'Werlhof-Institut für Hämostaseologie GmbH', 'geoPoint': {'lat': 52.37052, 'lon': 9.73322}}, {'city': 'Kiel', 'country': 'Germany', 'facility': 'Universitätsklinikum Schleswig-Holstein', 'geoPoint': {'lat': 54.32133, 'lon': 10.13489}}, {'city': 'Mainz', 'country': 'Germany', 'facility': 'Universitatsklinikum', 'geoPoint': {'lat': 49.98185, 'lon': 8.28008}}, {'city': 'München', 'country': 'Germany', 'facility': 'Klinikum der Universität', 'geoPoint': {'lat': 51.60698, 'lon': 13.31243}}, {'city': 'Athens', 'country': 'Greece', 'facility': 'Hemophilia center "LAIKO" general hospital', 'geoPoint': {'lat': 37.98376, 'lon': 23.72784}}, {'city': 'Catania', 'country': 'Italy', 'facility': 'Centro di Riferimento Regionale per Emofilia e Trombosi', 'geoPoint': {'lat': 37.49223, 'lon': 15.07041}}, {'city': 'Florence', 'country': 'Italy', 'facility': 'AOUC- Azienda Ospedaliero-Universitaria Carregi', 'geoPoint': {'lat': 43.77925, 'lon': 11.24626}}, {'zip': '20122', 'city': 'Milan', 'country': 'Italy', 'facility': 'University of Milan', 'geoPoint': {'lat': 45.46427, 'lon': 9.18951}}, {'city': 'Oslo', 'country': 'Norway', 'facility': 'Oslo University Hospital', 'geoPoint': {'lat': 59.91273, 'lon': 10.74609}}], 'overallOfficials': [{'name': 'Wolfgang MIESBACH, Dr', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Medizinische Klinik III, Goethe Universitat, D-60590 Frankfurt/Main (Germany)'}, {'name': 'Flora PEYVANDI, Prof.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Faculty of Medicine, University of Milan, 20122 Milan (Italy)'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Laboratoire français de Fractionnement et de Biotechnologies', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}