Ignite Creation Date:
2025-12-25 @ 5:00 AM
Ignite Modification Date:
2025-12-26 @ 4:00 AM
Study NCT ID:
NCT01658618
Status:
UNKNOWN
Last Update Posted:
2014-02-03
First Post:
2012-08-01
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Safety Study Providing 12 Months Follow-up From First Exposure to HP802-247 in Subjects With Venous Leg Ulcer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2016-10-31', 'releaseDate': '2016-09-13'}, {'resetDate': '2018-01-23', 'releaseDate': '2017-06-05'}], 'estimatedResultsFirstSubmitDate': '2016-09-13'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D014647', 'term': 'Varicose Ulcer'}, {'id': 'D014456', 'term': 'Ulcer'}], 'ancestors': [{'id': 'D014648', 'term': 'Varicose Veins'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D007871', 'term': 'Leg Ulcer'}, {'id': 'D012883', 'term': 'Skin Ulcer'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 440}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2012-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-01', 'completionDateStruct': {'date': '2015-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2014-01-31', 'studyFirstSubmitDate': '2012-08-01', 'studyFirstSubmitQcDate': '2012-08-02', 'lastUpdatePostDateStruct': {'date': '2014-02-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-08-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Primary Objective', 'timeFrame': '12 months', 'description': 'The objectives of this study are to identify new adverse events, examine ongoing adverse events not resolved in subjects who participated in the 802-247-09-029 trial, and record wound status.'}], 'secondaryOutcomes': [{'measure': 'Exploratory Objectives', 'timeFrame': '12 Months', 'description': 'The Health Economic objective for this study is to determine if there are differences in Health related Quality of Life (HRQoL) associated with the treatment assignment from the 802-247-09-029 Trial.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Venous leg ulcer', 'ulcer', 'venous stasis', 'compression', 'venous', 'venous stasis ulcer', 'vlu', 'hp802-247-09-029'], 'conditions': ['Venous Leg Ulcer']}, 'descriptionModule': {'briefSummary': 'This observations safety study is intended for subject who participated in the 802-247-09-029 study with the investigational product HP802-247 for venous leg ulcers and received at least one application of HP802-247 or Vehicle (an inactive substance). This study is being done for the following purposes:\n\n1. to identify new adverse events,\n2. to examine ongoing adverse events not resolved in subjects who participated in the 802-247-09-029 trial,\n3. to record wound status, and\n4. to determine if there are differences in Health Related Quality of Life (HRQoL) associated with the treatment assignment from the 802-247-09-029 Trial.\n\nInvestigational means that HP802-247 has not been approved by the U.S. Food and Drug Administration (FDA).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The cohorts will be carried over and include all subjects who were randomized in 802-247-09-029 and received at least one application of a test article. Subjects will be enrolled based on participation in the 802-247-09-029 trial, evidenced by randomization and completion (or discontinuation) in that trial and having received at least one application of test article.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Provide informed consent document\n* Subject was randomized in 802-247-09-029 and received at least one application of a test article.\n* Subject has ended their participation in 802-247-09-029 by virtue of completing the study, or by dropping out prior to completion.\n\nExclusion Criteria:\n\n* Subjects who refuse to provide written informed consent will be excluded from this trial.'}, 'identificationModule': {'nctId': 'NCT01658618', 'briefTitle': 'Safety Study Providing 12 Months Follow-up From First Exposure to HP802-247 in Subjects With Venous Leg Ulcer', 'organization': {'class': 'INDUSTRY', 'fullName': 'Healthpoint'}, 'officialTitle': 'A Non-Interventional Safety Study Providing 12 Months Follow-up From First Exposure to HP802-247 in Subjects With Venous Leg Ulcer', 'orgStudyIdInfo': {'id': '802-247-09-030'}}, 'armsInterventionsModule': {'interventions': [{'name': 'HP802-247', 'type': 'BIOLOGICAL'}]}, 'contactsLocationsModule': {'locations': [{'zip': '85306', 'city': 'Glendale', 'state': 'Arizona', 'country': 'United States', 'geoPoint': {'lat': 33.53865, 'lon': -112.18599}}, {'zip': '85006', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '85012', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '85723', 'city': 'Tucson', 'state': 'Arizona', 'country': 'United States', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}, {'zip': '85724', 'city': 'Tucson', 'state': 'Arizona', 'country': 'United States', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}, {'zip': '92009', 'city': 'Carlsbad', 'state': 'California', 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'overallOfficials': [{'name': 'Herbert B Slade, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Chief Medical Officer'}, {'name': 'Tommy Lee, MSHS', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Associate Director Clinical Operations'}, {'name': 'Robert Kirsner, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Investigator'}, {'name': 'William Marston, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Investigator'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Healthpoint', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2016-09-13', 'type': 'RELEASE'}, {'date': '2016-10-31', 'type': 'RESET'}, {'date': '2017-06-05', 'type': 'RELEASE'}, {'date': '2018-01-23', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Healthpoint'}}}}