Ignite Creation Date:
2025-12-24 @ 4:35 PM
Ignite Modification Date:
2025-12-27 @ 2:49 PM
Study NCT ID:
NCT05039866
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2025-05-25
First Post:
2021-08-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Long-Term Follow-up of Subjects Who Were Treated With ST-920
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000795', 'term': 'Fabry Disease'}, {'id': 'C567062', 'term': 'Fabry Disease, Cardiac Variant'}], 'ancestors': [{'id': 'D013106', 'term': 'Sphingolipidoses'}, {'id': 'D020140', 'term': 'Lysosomal Storage Diseases, Nervous System'}, {'id': 'D020739', 'term': 'Brain Diseases, Metabolic, Inborn'}, {'id': 'D001928', 'term': 'Brain Diseases, Metabolic'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D059345', 'term': 'Cerebral Small Vessel Diseases'}, {'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D040181', 'term': 'Genetic Diseases, X-Linked'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D008661', 'term': 'Metabolism, Inborn Errors'}, {'id': 'D008064', 'term': 'Lipidoses'}, {'id': 'D008052', 'term': 'Lipid Metabolism, Inborn Errors'}, {'id': 'D016464', 'term': 'Lysosomal Storage Diseases'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D052439', 'term': 'Lipid Metabolism Disorders'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'plasma, serum'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 48}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2021-08-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2039-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-05-21', 'studyFirstSubmitDate': '2021-08-20', 'studyFirstSubmitQcDate': '2021-09-01', 'lastUpdatePostDateStruct': {'date': '2025-05-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-09-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2029-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To evaluate long-term safety of ST-920', 'timeFrame': '4 years', 'description': 'To evaluate long-term safety of ST-920 by assessment of incidence and severity of adverse events (AEs)'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Fabry Disease', 'Gene Therapy', 'ST-920', 'Rare', 'Genetic', 'DNA', 'Sangamo', 'Long Term'], 'conditions': ['Fabry Disease', 'Fabry Disease, Cardiac Variant']}, 'descriptionModule': {'briefSummary': 'Long-term follow-up of subjects who received ST-920 in a previous trial (ST-920-201) and completed at least 52 weeks post-infusion follow-up in their primary protocol. Enrolled subjects will be followed for a total of up to 5 years following ST-920 infusion.', 'detailedDescription': 'Non-interventional, multi-center, long-term follow-up (LTFU) study of subjects dosed with ST-920 in the clinical study ST-920-201. All subjects dosed in the study who completed at least 52 weeks post-infusion follow-up in their primary protocol will be offered to participate. Subjects who enroll will be monitored for a total of up to 5 years following ST-920 infusion.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All subjects who have received ST-920 in separate parent trial and who have consented to participate in this Long Term Follow-up study.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subjects who received ST-920 therapy in a separate parent trial\n* Subjects who have consented to participate in this LTFU study.\n\nExclusion Criteria:\n\n-This study has no exclusion criteria'}, 'identificationModule': {'nctId': 'NCT05039866', 'briefTitle': 'Long-Term Follow-up of Subjects Who Were Treated With ST-920', 'organization': {'class': 'INDUSTRY', 'fullName': 'Sangamo Therapeutics'}, 'officialTitle': 'Long-Term Follow-up of Fabry Disease Subjects Who Were Treated With ST-920, an AAV2/6 Human Alpha Galactosidase A Gene Therapy', 'orgStudyIdInfo': {'id': 'ST-920-LT01'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Subjects who received ST-920', 'description': 'Subjects who received ST-920 in a separate parent trial', 'interventionNames': ['Biological: ST-920']}], 'interventions': [{'name': 'ST-920', 'type': 'BIOLOGICAL', 'description': 'No study drug is administered in this study. Subjects who received ST-920 in a separate parent trial will be evaluated in this trial for long-term safety.', 'armGroupLabels': ['Subjects who received ST-920']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92697', 'city': 'Irvine', 'state': 'California', 'country': 'United States', 'facility': 'University of California, Irvine', 'geoPoint': {'lat': 33.66946, 'lon': -117.82311}}, {'zip': '33620', 'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'facility': 'University of South Florida', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'zip': '30322', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Emory University School of Medicine', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '52242', 'city': 'Iowa City', 'state': 'Iowa', 'country': 'United States', 'facility': 'University of Iowa Hospital and Clinics', 'geoPoint': {'lat': 41.66113, 'lon': -91.53017}}, {'zip': '55455', 'city': 'Minneapolis', 'state': 'Minnesota', 'country': 'United States', 'facility': 'University of Minnesota Medical Center', 'geoPoint': {'lat': 44.97997, 'lon': -93.26384}}, {'zip': '10029', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Mt. Sinai Hospital', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '45229', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': "Cincinnati Children's Hospital Medical Center", 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'zip': '22030', 'city': 'Fairfax', 'state': 'Virginia', 'country': 'United States', 'facility': 'Lysosomal & Rare Disorders Research & Treatment Center (LDRTC)', 'geoPoint': {'lat': 38.84622, 'lon': -77.30637}}, {'zip': '3050', 'city': 'Parkville', 'state': 'Victoria', 'country': 'Australia', 'facility': 'The Royal Melbourne Hospital', 'geoPoint': {'lat': -37.78333, 'lon': 144.95}}, {'zip': 'T2E 7Z4', 'city': 'Calgary', 'state': 'Alberta', 'country': 'Canada', 'facility': 'M.A.G.I.C. Clinic Ltd.', 'geoPoint': {'lat': 51.05011, 'lon': -114.08529}}, {'city': 'Würzburg', 'country': 'Germany', 'facility': 'University Hospital of Würzburg', 'geoPoint': {'lat': 49.79391, 'lon': 9.95121}}, {'zip': 'CB2 0QQ', 'city': 'Cambridge', 'country': 'United Kingdom', 'facility': "Addenbrooke's Hospital", 'geoPoint': {'lat': 52.2, 'lon': 0.11667}}, {'city': 'London', 'country': 'United Kingdom', 'facility': 'Royal Free Hospital', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}], 'overallOfficials': [{'name': 'Medical Monitor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Sangamo Therapeutics, Inc.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sangamo Therapeutics', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}