Ignite Creation Date:
2025-12-24 @ 1:56 PM
Ignite Modification Date:
2025-12-27 @ 9:38 PM
Study NCT ID:
NCT04567095
Status:
WITHDRAWN
Last Update Posted:
2020-10-23
First Post:
2020-09-01
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Evaluate Awareness and Knowledge of the Fibristal Additional Risk Minimization Measures Among Patients in Canada
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007889', 'term': 'Leiomyoma'}], 'ancestors': [{'id': 'D009379', 'term': 'Neoplasms, Muscle Tissue'}, {'id': 'D018204', 'term': 'Neoplasms, Connective and Soft Tissue'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}, 'patientRegistry': False}, 'statusModule': {'whyStopped': 'This study was cancelled before any data collection due to business reasons.', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2020-10-31', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-10', 'completionDateStruct': {'date': '2021-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-10-21', 'studyFirstSubmitDate': '2020-09-01', 'studyFirstSubmitQcDate': '2020-09-23', 'lastUpdatePostDateStruct': {'date': '2020-10-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-09-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentages of patients with correct responses to the knowledge related questions based on the contents of the Fibristal Patient Alert Card.', 'timeFrame': '18 - 24 months', 'description': 'Correct responses to knowledge-related questions (i.e, potential of fibristal to cause liver injury, signs and symptoms of liver problems, and what to do in case of signs and symptoms of liver problems.)'}], 'secondaryOutcomes': [{'measure': 'Percentages of patients that recall recieving and using the Fibristal Patient Alert Card', 'timeFrame': '18 - 24 months', 'description': 'Receipt and use of the Fibristal Patient Alert Card,'}, {'measure': "Percentage of patients that recall their HCPs' ordering of required liver function tests in accordance with the recommendations in the aRMM/CPM", 'timeFrame': '18 - 24 months', 'description': "Timing and frequency of liver testing conducted by the patients's HCP"}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Uterine Fibroids']}, 'descriptionModule': {'briefSummary': 'This is a non-interventional, cross-sectional survey study to evaluate the effectiveness of the Additional Risk Minimization Measures for Fibristal among Patients in Canada.', 'detailedDescription': 'Data will be collected via web-based data capture and paper surveys depending on patient preference. The survey will be conducted in a single wave over 6 months. All data will be maintained in compliance with local regulations.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'genderBased': True, 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The survey will endeavor to collect 150 completed patient surveys', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients who have received Fibristal within 6 months of completing the survey.\n* Patients who have provided permission to share their responses in aggregate with Health Canada.\n* Patients who have provided informed consent for their participation in the survey.\n\nExclusion Criteria:\n\n* Patients who participated in the cognitive pre-testing of the survey questionnaire to be used for the study.\n* Patients who have been direct employees of Allergan, ICON, Health Canada, or Professional Targeted Marketing (PTM) within the past year.'}, 'identificationModule': {'nctId': 'NCT04567095', 'briefTitle': 'A Study to Evaluate Awareness and Knowledge of the Fibristal Additional Risk Minimization Measures Among Patients in Canada', 'organization': {'class': 'INDUSTRY', 'fullName': 'Allergan'}, 'officialTitle': 'A Cross-sectional Study Among Patients in Canada to Assess Awareness and Knowledge of the Fibristal Patient Alert Card', 'orgStudyIdInfo': {'id': 'CMO-EPI-WH-0626'}}, 'contactsLocationsModule': {'locations': [{'zip': '92622', 'city': 'Irvine', 'state': 'California', 'country': 'United States', 'facility': 'Clinical Trials Registry Team', 'geoPoint': {'lat': 33.66946, 'lon': -117.82311}}], 'overallOfficials': [{'name': 'Ahunna Ukah', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Allergan'}]}, 'ipdSharingStatementModule': {'url': 'http://www.allerganclinicaltrials.com/', 'infoTypes': ['STUDY_PROTOCOL', 'CSR'], 'timeFrame': 'After having received regulatory approval in the United States and/or the European Union in a given indication and the primary manuscript from the trial has been published.', 'ipdSharing': 'YES', 'description': 'Allergan will share de-identified patient-level data and study-level data including protocols and clinical study reports for phase 2 - 4 trials completed after 2008 that are registered to ClinicalTrials.gov or EudraCT, have received regulatory approval in the United States and/or the European Union in a given indication and the primary manuscript from the trial has been published. To request access to the data, the researcher must sign a data use agreement and any shared data is to be used for non-commercial purposes. More information can be found on http://www.allerganclinicaltrials.com/.', 'accessCriteria': 'To request access to the data, the researcher must sign a data use agreement and any shared data is to be used for non-commercial purposes.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Allergan', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}