Ignite Creation Date:
2025-12-25 @ 3:44 AM
Ignite Modification Date:
2026-02-06 @ 3:11 PM
Study NCT ID:
NCT02568202
Status:
COMPLETED
Last Update Posted:
2016-01-12
First Post:
2015-09-18
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Bridging Hemophilia B Experiences, Results and Opportunities Into Solutions (B-HERO-S)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002836', 'term': 'Hemophilia B'}], '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'}, {'id': 'D040181', 'term': 'Genetic Diseases, X-Linked'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 449}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-01', 'completionDateStruct': {'date': '2015-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-01-11', 'studyFirstSubmitDate': '2015-09-18', 'studyFirstSubmitQcDate': '2015-10-01', 'lastUpdatePostDateStruct': {'date': '2016-01-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-10-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'An online survey of Prevalence and characteristics of adults with hemophilia B', 'timeFrame': 'At day 0'}, {'measure': 'An online survey of Prevalence and characteristics of children with hemophilia B (and their parents)', 'timeFrame': 'At day 0'}, {'measure': 'An online survey of Prevalence of psychosocial and other comorbidities in patients with hemophilia B', 'timeFrame': 'At day 0'}], 'secondaryOutcomes': [{'measure': 'Percentage of participants reporting difficulty with access to treatment (e.g. factor)', 'timeFrame': 'At day 0'}, {'measure': 'An online survey of Percentage of participants reporting difficulty with access to treatment centers', 'timeFrame': 'At day 0'}, {'measure': 'Percentage of participants reporting hemophilia interference with employment/education', 'timeFrame': 'At day 0'}, {'measure': 'Percentage of participants reporting hemophilia interference with physical activities', 'timeFrame': 'At day 0'}, {'measure': 'Percentage of participants reporting hemophilia interference with relationships', 'timeFrame': 'At day 0'}, {'measure': 'Health related quality of life: EuroQol', 'timeFrame': 'At day 0'}, {'measure': 'Health related quality of life:EQ-5D-5L', 'timeFrame': 'At day 0'}, {'measure': 'Health related quality of life: VAS (Visual Analog Scale)', 'timeFrame': 'At day 0'}, {'measure': 'Health related quality of life: BPI (Brief Pain Inventory) short form - Pain severity and interference', 'timeFrame': 'At day 0'}, {'measure': 'Health related quality of life: HAL (Hemophilia Activities List)', 'timeFrame': 'At day 0'}, {'measure': 'Health related quality of life: HemoCAB (Caregiver Hemophilia Burden Scale', 'timeFrame': 'At day 0'}, {'measure': 'Drivers of psychosocial impact (e.g. hemophilia severity, age, weight, prior treatment history, education)', 'timeFrame': 'At day 0'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Haemostasis', 'Congenital Bleeding Disorder', 'Haemophilia B']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://novonordisk-trials.com', 'label': 'Clinical Trials at Novo Nordisk'}]}, 'descriptionModule': {'briefSummary': 'This study is conducted in the United States of America (USA). Tha aim of this study is bridging Hemophilia B Experiences, Results and Opportunities into Solutions (B-HERO-S).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'This study will investigate adult patients at least 18 years of age with mild-severe hemophilia B and caregivers of children (current age below 18 years) with hemophilia B.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adults aged below or equal to 18 years with hemophilia B (any severity, with or without inhibitors)\n* Caregivers of children currently aged below 18 years with hemophilia B (any severity, with or without inhibitors)\n* Subjects must have access to the internet, either at home or at a location convenient to them\n* Provision of informed consent before the start of any survey-related activities\n\nExclusion Criteria:\n\n* Inability to understand and comply with written instructions in English\n* Previous completion of the B-HERO-S study with receipt of compensation\n* Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation'}, 'identificationModule': {'nctId': 'NCT02568202', 'briefTitle': 'Bridging Hemophilia B Experiences, Results and Opportunities Into Solutions (B-HERO-S)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novo Nordisk A/S'}, 'officialTitle': 'Bridging Hemophilia B Experiences, Results and Opportunities Into Solutions (B-HERO-S)', 'orgStudyIdInfo': {'id': 'HAEM-4268'}, 'secondaryIdInfos': [{'id': 'U1111-1171-8168', 'type': 'OTHER', 'domain': 'WHO'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Survey', 'interventionNames': ['Other: No treatment given']}], 'interventions': [{'name': 'No treatment given', 'type': 'OTHER', 'description': 'This is an online web-based cross-sectional survey in which participants will complete one of two questionnaires.\n\nThere will be no treatment.', 'armGroupLabels': ['Survey']}]}, 'contactsLocationsModule': {'locations': [{'zip': '08536', 'city': 'Plainsboro', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Novo Nordisk Clinical Trial Call Center', 'geoPoint': {'lat': 40.33344, 'lon': -74.60043}}], 'overallOfficials': [{'name': 'Global Clinical Registry (GCR, 1452)', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Novo Nordisk A/S'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Novo Nordisk A/S', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}