Ignite Creation Date:
2025-12-24 @ 9:14 PM
Ignite Modification Date:
2026-02-01 @ 8:29 PM
Study NCT ID:
NCT06481904
Status:
RECRUITING
Last Update Posted:
2025-10-23
First Post:
2024-06-26
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Registry for Stage 2 Type 1 Diabetes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003922', 'term': 'Diabetes Mellitus, Type 1'}], 'ancestors': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-09-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10', 'completionDateStruct': {'date': '2037-01-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-10-22', 'studyFirstSubmitDate': '2024-06-26', 'studyFirstSubmitQcDate': '2024-06-26', 'lastUpdatePostDateStruct': {'date': '2025-10-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-07-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2037-01-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of adverse events of special interests (AESI)', 'timeFrame': 'Throughout the study, approximately 10 years', 'description': 'Presence of AESIs including cytokine release syndrome (CRS), serious infections, hypersensitivity reactions, lymphoproliferative disorders, and malignancies'}, {'measure': 'Number of serious adverse events (SAE)', 'timeFrame': 'Throughout the study, approximately 10 years'}, {'measure': 'Number of adverse events (AE) in mothers, fetuses, and infants exposed to TZIELD during pregnancy', 'timeFrame': 'From start of pregnancy to 12 months post-partum'}, {'measure': 'Number of maternal pregnancy-related events', 'timeFrame': 'From start of pregnancy to 12 months post-partum'}, {'measure': 'Developmental outcomes of the infant', 'timeFrame': 'From birth of infant to 12 months'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True}, 'conditionsModule': {'conditions': ['Type 1 Diabetes']}, 'descriptionModule': {'briefSummary': 'Stage 2 Type 1 Diabates (T1D) is an early stage of T1D characterized by dysglycemia but not yet leading to clinical symptoms. Progression of the disease to Stage 3 (clinical T1D), leads to overt hyperglycemia requiring eventually exogenous insulin.\n\nTZIELD® (teplizumab-mzwv) has been approved to delay onset of stage 3 T1D, by the United States (US) Food and Drug Administration (FDA) for adults and children aged 8 years and older with Stage 2 T1D.\n\nThe purpose of this study is to collect general information on patients with stage 2 T1D and further information on the long-term effects of TZIELD® in patients with Stage 2 T1D, treated as per standard of care.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients in the US diagnosed with Stage 2 Type 1 Diabetes', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nTZIELD-Exposed Cohort\n\n* Patients in the US diagnosed with Stage 2 T1D who are planned to initiate TZIELD treatment according to the currently approved label or who have initiated TZIELD treatment within 6 months prior to enrollment:\n* Day 1: 65 mcg/m2\n* Day 2: 125 mcg/m2\n* Day 3: 250 mcg/m2\n* Day 4: 500 mcg/m2\n* Days 5 through 14: 1,030 mcg/m2 per day\n* Cumulative dose is approximately 11,240 mcg/m2\n* Appropriate written informed consent/assent as applicable for the age of the patient\n\nTZIELD-Unexposed Cohort\n\n* Patients in the US diagnosed with Stage 2 T1D but who are not treated with TZIELD\n* Appropriate written informed consent/assent as applicable for the age of the patient\n\nExclusion Criteria:\n\n* Patients who initiated TZIELD treatment more than 6 months prior to enrollment\n* Patients who had participated in a previous clinical trial for TZIELD\n* Patients in an ongoing clinical trial of an investigational product or who had ended participation within 6 months prior to study enrollment; patients participating in other observational studies may be enrolled'}, 'identificationModule': {'nctId': 'NCT06481904', 'briefTitle': 'Registry for Stage 2 Type 1 Diabetes', 'organization': {'class': 'INDUSTRY', 'fullName': 'Sanofi'}, 'officialTitle': 'An Observational, Long-term Safety Study of TZIELD® (Teplizumab-mzwv) in Patients With Stage 2 Type 1 Diabetes', 'orgStudyIdInfo': {'id': 'OBS18117'}, 'secondaryIdInfos': [{'id': 'U1111-1306-6690', 'type': 'REGISTRY', 'domain': 'ICTRP'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'TZIELD group', 'description': 'Patients prior to the initiation of TZIELD treatment or initiated TZIELD treatment within 6 months to study enrollment', 'interventionNames': ['Drug: TZIELD (teplizumab-mzwv)']}, {'label': 'Comparator group', 'description': 'Patients not planned to be treated'}], 'interventions': [{'name': 'TZIELD (teplizumab-mzwv)', 'type': 'DRUG', 'description': 'This study will not administer any treatment, only observe the treatment as prescribed in real-world clinical practice.', 'armGroupLabels': ['TZIELD group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90095', 'city': 'Los Angeles', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'University of California Los Angeles Health- Site Number : 8400020', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '94158', 'city': 'San Francisco', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'University of California San Francisco - Mission Bay- Site Number : 8400005', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '80045', 'city': 'Aurora', 'state': 'Colorado', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'University of Colorado Hospital- Site Number : 8400026', 'geoPoint': {'lat': 39.72943, 'lon': -104.83192}}, {'zip': '06510', 'city': 'New Haven', 'state': 'Connecticut', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Yale University School of Medicine- Site Number : 8400025', 'geoPoint': {'lat': 41.30815, 'lon': -72.92816}}, {'zip': '32207', 'city': 'Jacksonville', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'facility': "Nemours Children's Speciality Care- Jacksonville- Site Number : 8400006", 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}, {'zip': '60637', 'city': 'Chicago', 'state': 'Illinois', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'University of Chicago Medical Center- Site Number : 8400017', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '46202', 'city': 'Indianapolis', 'state': 'Indiana', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Riley Hospital for Children at IU Health- Site Number : 8400004', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}, {'zip': '40202', 'city': 'Louisville', 'state': 'Kentucky', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Norton Healthcare- Site Number : 8400030', 'geoPoint': {'lat': 38.25424, 'lon': -85.75941}}, {'zip': '21205', 'city': 'Baltimore', 'state': 'Maryland', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Johns Hopkins School of Medicine- Site Number : 8400031', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '48109', 'city': 'Ann Arbor', 'state': 'Michigan', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'University of Michigan Health System - Ann Arbor- Site Number : 8400028', 'geoPoint': {'lat': 42.27756, 'lon': -83.74088}}, {'zip': '48334', 'city': 'Farmington Hills', 'state': 'Michigan', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Associated Endocrinologists, PC- Site Number : 8400039', 'geoPoint': {'lat': 42.48531, 'lon': -83.37716}}, {'zip': '49503', 'city': 'Grand Rapids', 'state': 'Michigan', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Corewell Health- Site Number : 8400009', 'geoPoint': {'lat': 42.96336, 'lon': -85.66809}}, {'zip': '55902', 'city': 'Rochester', 'state': 'Minnesota', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Mayo Clinic- Site Number : 8400010', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}, {'zip': '64108', 'city': 'Kansas City', 'state': 'Missouri', 'status': 'RECRUITING', 'country': 'United States', 'facility': "Children's Mercy Adelle Hall Campus- Site Number : 8400014", 'geoPoint': {'lat': 39.09973, 'lon': -94.57857}}, {'zip': '14222', 'city': 'Buffalo', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'facility': "Women and Children's Hospital of Buffalo- Site Number : 8400018", 'geoPoint': {'lat': 42.88645, 'lon': -78.87837}}, {'zip': '11030', 'city': 'Manhasset', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Feinstein Institute for Medical Research (Northwell)- Site Number : 8400016', 'geoPoint': {'lat': 40.79788, 'lon': -73.69957}}, {'zip': '10306', 'city': 'Staten Island', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'facility': "Ten's Medical PC- Site Number : 8400027", 'geoPoint': {'lat': 40.56233, 'lon': -74.13986}}, {'zip': '13210', 'city': 'Syracuse', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'SUNY Upstate Medical University - Syracuse- Site Number : 8400007', 'geoPoint': {'lat': 43.04812, 'lon': -76.14742}}, {'zip': '27514', 'city': 'Chapel Hill', 'state': 'North Carolina', 'status': 'RECRUITING', 'country': 'United States', 'facility': "UNC Children's Hospital- Site Number : 8400008", 'geoPoint': {'lat': 35.9132, 'lon': -79.05584}}, {'zip': '45229', 'city': 'Cincinnati', 'state': 'Ohio', 'status': 'RECRUITING', 'country': 'United States', 'facility': "Cincinnati Children's Hospital Medical Center- Site Number : 8400024", 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'zip': '44106', 'city': 'Cleveland', 'state': 'Ohio', 'status': 'RECRUITING', 'country': 'United States', 'facility': "Rainbow Babies And Children's Hospital- Site Number : 8400011", 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'zip': '31901', 'city': 'Columbus', 'state': 'Ohio', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Columbus Regional Healthcare- Site Number : 8400013', 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}, {'zip': '43210', 'city': 'Columbus', 'state': 'Ohio', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'The Ohio State University- Site Number : 8400032', 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}, {'zip': '19104', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Hospital of The University of Pennsylvania- Site Number : 8400021', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '19104', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'status': 'RECRUITING', 'country': 'United States', 'facility': "The Children's Hospital of Philadelphia- Site Number : 8400029", 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '38133', 'city': 'Bartlett', 'state': 'Tennessee', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'AM Diabetes & Endocrinology Center- Site Number : 8400012', 'geoPoint': {'lat': 35.20453, 'lon': -89.87398}}, {'zip': '37232-5536', 'city': 'Nashville', 'state': 'Tennessee', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Vanderbilt University Medical Center- Site Number : 8400023', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'zip': '75235', 'city': 'Dallas', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'University of Texas - Southwestern Medical Center- Site Number : 8400003', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'facility': "Texas Children's Hospital- Site Number : 8400002", 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '84132-0001', 'city': 'Salt Lake City', 'state': 'Utah', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'University of Utah Health Care- Site Number : 8400019', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}, {'zip': '26505', 'city': 'Morgantown', 'state': 'West Virginia', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'United BioSource Corporation- Site Number : 8400001', 'geoPoint': {'lat': 39.62953, 'lon': -79.9559}}], 'centralContacts': [{'name': 'Trial Transparency email recommended (Toll free for US & Canada)', 'role': 'CONTACT', 'email': 'Contact-US@sanofi.com', 'phone': '800-633-1610', 'phoneExt': 'option 6'}], 'overallOfficials': [{'name': 'Clinical Sciences & Operations', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Sanofi'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': "Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org"}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sanofi', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}