Ignite Creation Date:
2025-12-24 @ 6:33 PM
Ignite Modification Date:
2026-01-18 @ 6:53 PM
Study NCT ID:
NCT01970657
Status:
COMPLETED
Last Update Posted:
2017-06-22
First Post:
2013-10-22
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Observational Study Providing 12 Months of Safety Follow-Up From First Exposure to HP802-247
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014647', 'term': 'Varicose 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'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'NONE_RETAINED', 'description': 'The treatment assignment codes and randomization schedule for the prior trial will be maintained for this observational study. The treatment assignments will not be made known to the Investigators until the present follow-up study has been completed by all consenting subjects thus keeping treating physician and subjects blind to treatment.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 221}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-06', 'completionDateStruct': {'date': '2015-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-06-21', 'studyFirstSubmitDate': '2013-10-22', 'studyFirstSubmitQcDate': '2013-10-22', 'lastUpdatePostDateStruct': {'date': '2017-06-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-10-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Assess new adverse events, and ongoing adverse events not resolved, in subjects who were exposed to a Investigational Medicinal Product in the 802-247-09-032 trial.', 'timeFrame': 'Up to 12 months from first application of test article in the 802-247-09-032 study', 'description': 'The evaluation of safety included analysis of new test article-related events, as well as continued follow-up of those adverse events that originated in the prior study.'}], 'secondaryOutcomes': [{'measure': 'Follow-up on the status of the target ulcer as open, re-opened or closed.', 'timeFrame': 'Up to 12 months from first application of test article in the 802-247-09-032 study', 'description': 'At each study visit the status of the target ulcer was assessed as remaining closed, re-opened, or a new closure.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Venous Stasis Ulcer', 'VLU'], 'conditions': ['Venous Leg Ulcer (VLU)']}, 'descriptionModule': {'briefSummary': 'This observational safety follow-up study enrolled subjects from the 802-247-09-032 study with the investigational product HP802-247 for venous leg ulcers, who received at least one application of HP802-247 or Vehicle (Placebo). 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 802-247-09-032 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 802-247-09-032 Trial.\n\nAbout 440 subjects were to participate depending upon subject enrollment from the previous study, 802-247-09-032. The study was conducted in approximately 50 sites in Europe.', 'detailedDescription': 'Subjects transitioned to this observational study immediately upon exit from the 802-247-09-032 trial. This ensured a total of 12 months of safety observations and wound status data were obtained from the time of the first application of HP802-247. This study provided consecutive visits at intervals of 8 weeks until a total of 12 months of safety follow-up had been achieved, based on the initial application of Investigational Medicinal Product in the prior study. Specifically, this study examines all new and unresolved ongoing adverse events.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* The informed consent document must be read, signed, and dated by the subject or the subject's legally authorized representative before conducting any study procedures or exams.\n* Subject was randomized in 802-247-09-032 and received at least one application of test article.\n* Subject has ended their participation in 802-247-09-032 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 for this study will be excluded from this study."}, 'identificationModule': {'nctId': 'NCT01970657', 'briefTitle': 'Observational Study Providing 12 Months of Safety Follow-Up From First Exposure to HP802-247', 'organization': {'class': 'INDUSTRY', 'fullName': 'Healthpoint'}, 'officialTitle': 'An Observational Study Providing 12 Months of Safety Follow-Up From First Exposure to HP802-247 in Subjects Who Participated in Study 802-247-09-032(EU)', 'orgStudyIdInfo': {'id': '802-247-09-033'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'HP802-247 in prior study', 'description': 'Observational safety follow up study, no treatment specified', 'interventionNames': ['Biological: No treatment specified']}, {'label': 'Vehicle Control in prior study', 'description': 'Observational safety follow up study, no treatment specified', 'interventionNames': ['Biological: No treatment']}], 'interventions': [{'name': 'No treatment specified', 'type': 'BIOLOGICAL', 'description': 'No intervention', 'armGroupLabels': ['HP802-247 in prior study']}, {'name': 'No treatment', 'type': 'BIOLOGICAL', 'description': 'None specified', 'armGroupLabels': ['Vehicle Control in prior study']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Brussels', 'country': 'Belgium', 'geoPoint': {'lat': 50.85045, 'lon': 4.34878}}, {'city': 'Edegem', 'country': 'Belgium', 'geoPoint': {'lat': 51.15662, 'lon': 4.44504}}, {'city': 'Ghent', 'country': 'Belgium', 'geoPoint': {'lat': 51.05, 'lon': 3.71667}}, {'city': 'Brno', 'country': 'Czechia', 'geoPoint': {'lat': 49.19522, 'lon': 16.60796}}, {'city': 'Hradec Králové', 'country': 'Czechia', 'geoPoint': {'lat': 50.20923, 'lon': 15.83277}}, {'city': 'Olomouc', 'country': 'Czechia', 'geoPoint': {'lat': 49.59552, 'lon': 17.25175}}, {'city': 'Pardubice', 'country': 'Czechia', 'geoPoint': {'lat': 50.04075, 'lon': 15.77659}}, {'city': 'Plzen-Bory', 'country': 'Czechia'}, {'city': 'Prague', 'country': 'Czechia', 'geoPoint': {'lat': 50.08804, 'lon': 14.42076}}, {'city': 'Třebíč', 'country': 'Czechia', 'geoPoint': {'lat': 49.21492, 'lon': 15.88166}}, {'city': 'Uherské Hradiště', 'country': 'Czechia', 'geoPoint': {'lat': 49.06975, 'lon': 17.45969}}, {'city': 'Ústí nad Labem', 'country': 'Czechia', 'geoPoint': {'lat': 50.6607, 'lon': 14.03227}}, {'city': 'Bochum', 'country': 'Germany', 'geoPoint': {'lat': 51.48165, 'lon': 7.21648}}, {'city': 'Bonn', 'country': 'Germany', 'geoPoint': {'lat': 50.73438, 'lon': 7.09549}}, {'city': 'Cologne', 'country': 'Germany', 'geoPoint': {'lat': 50.93333, 'lon': 6.95}}, {'city': 'Dresden', 'country': 'Germany', 'geoPoint': {'lat': 51.05089, 'lon': 13.73832}}, {'city': 'Düsseldorf', 'country': 'Germany', 'geoPoint': {'lat': 51.22172, 'lon': 6.77616}}, {'city': 'Essen', 'country': 'Germany', 'geoPoint': {'lat': 51.45657, 'lon': 7.01228}}, {'city': 'Freiburg im Breisgau', 'country': 'Germany', 'geoPoint': {'lat': 47.9959, 'lon': 7.85222}}, {'city': 'Göttingen', 'country': 'Germany', 'geoPoint': {'lat': 51.53443, 'lon': 9.93228}}, {'city': 'Greifswald', 'country': 'Germany', 'geoPoint': {'lat': 54.08905, 'lon': 13.40244}}, {'city': 'Hamburg', 'country': 'Germany', 'geoPoint': {'lat': 53.55073, 'lon': 9.99302}}, {'city': 'Kiel', 'country': 'Germany', 'geoPoint': {'lat': 54.32133, 'lon': 10.13489}}, {'city': 'Krefeld', 'country': 'Germany', 'geoPoint': {'lat': 51.33645, 'lon': 6.55381}}, {'city': 'Magdeburg', 'country': 'Germany', 'geoPoint': {'lat': 52.13129, 'lon': 11.63189}}, {'city': 'München', 'country': 'Germany', 'geoPoint': {'lat': 51.60698, 'lon': 13.31243}}, {'city': 'Münster', 'country': 'Germany', 'geoPoint': {'lat': 51.96236, 'lon': 7.62571}}, {'city': 'Budapest', 'country': 'Hungary', 'geoPoint': {'lat': 47.49835, 'lon': 19.04045}}, {'city': 'Debrecen', 'country': 'Hungary', 'geoPoint': {'lat': 47.53167, 'lon': 21.62444}}, {'city': 'Hatvan', 'country': 'Hungary', 'geoPoint': {'lat': 47.66667, 'lon': 19.68333}}, {'city': 'Orosháza', 'country': 'Hungary', 'geoPoint': {'lat': 46.56667, 'lon': 20.66667}}, {'city': 'Sátoraljaújhely', 'country': 'Hungary', 'geoPoint': {'lat': 48.39492, 'lon': 21.65871}}, {'city': 'Szeged', 'country': 'Hungary', 'geoPoint': {'lat': 46.253, 'lon': 20.14824}}, {'city': 'Szolnok', 'country': 'Hungary', 'geoPoint': {'lat': 47.18066, 'lon': 20.19835}}, {'city': 'Krakow', 'country': 'Poland', 'geoPoint': {'lat': 50.06143, 'lon': 19.93658}}, {'city': 'Lodz', 'country': 'Poland', 'geoPoint': {'lat': 51.77058, 'lon': 19.47395}}, {'city': 'Lublin', 'country': 'Poland', 'geoPoint': {'lat': 51.25058, 'lon': 22.57009}}, {'city': 'Poznan', 'country': 'Poland', 'geoPoint': {'lat': 52.40692, 'lon': 16.92993}}, {'city': 'Rzeszów', 'country': 'Poland', 'geoPoint': {'lat': 50.04132, 'lon': 21.99901}}, {'city': 'Studzionka', 'country': 'Poland', 'geoPoint': {'lat': 49.96232, 'lon': 18.7728}}, {'city': 'Warsaw', 'country': 'Poland', 'geoPoint': {'lat': 52.22977, 'lon': 21.01178}}, {'city': 'Wroclaw', 'country': 'Poland', 'geoPoint': {'lat': 51.10286, 'lon': 17.03006}}, {'city': 'Zabrze', 'country': 'Poland', 'geoPoint': {'lat': 50.32492, 'lon': 18.78576}}], 'overallOfficials': [{'name': 'Wolfgang Vanscheidt, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Freiburg-Practice for Dermatology'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'Publication submitted to Journal of Vascular Surgery in May 2017'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Healthpoint', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}