[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100422855":3},{"organization":4,"outcomesModule":7,"designInfo":29,"detailedDescription":11,"studyPopulation":11,"armGroups":35,"interventions":41,"overallOfficials":11,"centralContacts":49,"locations":55,"responsibleParty":327,"collaborators":11,"id":329,"slug":11,"hasResults":330,"nctId":331,"briefTitle":332,"officialTitle":333,"acronym":11,"eligibilityCriteria":334,"healthyVolunteers":330,"sex":335,"minAge":336,"maxAge":337,"enrollmentInfo":338,"targetDuration":11,"studyType":341,"phases":342,"briefSummary":344,"conditions":345,"keywords":11,"overallStatus":58,"whyStopped":11,"lastUpdateSubmitDate":349,"lastUpdatePostDateStruct":350,"startDateStruct":353,"completionDateStruct":355,"leadSponsor":357,"locationsCount":358},{"fullName":5,"class":6},"Vertex Pharmaceuticals Incorporated","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":16,"otherOutcomes":11},[9,13],{"measure":10,"description":11,"timeFrame":12},"Part A: Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs)",null,"From VX-880 infusion to end of study (up to 5 years)",{"measure":14,"description":11,"timeFrame":15},"Parts B and C: Proportion of Participants who are Insulin Independent with Absence of Severe Hypoglycemic Events (SHEs)","1 year after achieving insulin independence",[17,20,22,24,26],{"measure":18,"description":11,"timeFrame":19},"Parts B and C: Proportion of Participants who are Insulin Independent","At 1 year after VX-880 infusion",{"measure":21,"description":11,"timeFrame":19},"Parts B and C: Proportion of Participants Free from SHEs with a Glycosylated Hemoglobin (HbA1c) less than (\u003C) 7.0%",{"measure":23,"description":11,"timeFrame":19},"Parts B and C: Change From Baseline in Glycosylated Hemoglobin (HbA1c)",{"measure":25,"description":11,"timeFrame":12},"Parts B and C: Proportion of Participants Who Maintain Insulin Independence for at least 1 year",{"measure":27,"description":11,"timeFrame":28},"Parts B and C: Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs)","From Signing of informed consent to end of study (up to 5 years)",{"allocation":30,"interventionModel":31,"interventionModelDescription":11,"primaryPurpose":32,"observationalModel":11,"timePerspective":11,"maskingInfo":33},"NA","SINGLE_GROUP","TREATMENT",{"masking":34,"maskingDescription":11,"whoMasked":11},"NONE",[36],{"label":37,"type":38,"description":11,"interventionNames":39},"VX-880","EXPERIMENTAL",[40],"Biological: VX-880",[42],{"type":43,"name":37,"description":44,"armGroupLabels":45,"otherNames":46},"BIOLOGICAL","Infused into the hepatic portal vein.",[37],[47,48],"Zimislecel","Formerly known as STx-02",[50],{"name":51,"role":52,"phone":53,"phoneExt":11,"email":54},"Medical Information","CONTACT","617-341-6777","medicalinfo@vrtx.com",[56,70,79,89,100,106,116,126,136,145,155,165,175,185,193,201,209,219,227,237,247,257,267,277,282,292,303,311,319],{"facility":57,"status":58,"city":59,"state":60,"zip":61,"country":62,"countryCode":63,"cosmosGeoPoint":64,"geoPoint":69,"contacts":11},"City of Hope","RECRUITING","Duarte","California","91010","United States","US",{"type":65,"coordinates":66},"Point",[67,68],-117.97729,34.13945,{"lat":68,"lon":67},{"facility":71,"status":58,"city":72,"state":60,"zip":73,"country":62,"countryCode":63,"cosmosGeoPoint":74,"geoPoint":78,"contacts":11},"University of California San Francisco","San Francisco","94143",{"type":65,"coordinates":75},[76,77],-122.41942,37.77493,{"lat":77,"lon":76},{"facility":80,"status":58,"city":81,"state":82,"zip":83,"country":62,"countryCode":63,"cosmosGeoPoint":84,"geoPoint":88,"contacts":11},"UHealth Diabetes Research Institute","Miami","Florida","33136",{"type":65,"coordinates":85},[86,87],-80.19366,25.77427,{"lat":87,"lon":86},{"facility":90,"status":91,"city":92,"state":93,"zip":94,"country":62,"countryCode":63,"cosmosGeoPoint":95,"geoPoint":99,"contacts":11},"Northwestern Organ Transplant Center","COMPLETED","Chicago","Illinois","60611",{"type":65,"coordinates":96},[97,98],-87.65005,41.85003,{"lat":98,"lon":97},{"facility":101,"status":58,"city":92,"state":93,"zip":102,"country":62,"countryCode":63,"cosmosGeoPoint":103,"geoPoint":105,"contacts":11},"University of Chicago","60637",{"type":65,"coordinates":104},[97,98],{"lat":98,"lon":97},{"facility":107,"status":58,"city":108,"state":109,"zip":110,"country":62,"countryCode":63,"cosmosGeoPoint":111,"geoPoint":115,"contacts":11},"Johns Hopkins University","Baltimore","Maryland","21287",{"type":65,"coordinates":112},[113,114],-76.61219,39.29038,{"lat":114,"lon":113},{"facility":117,"status":58,"city":118,"state":119,"zip":120,"country":62,"countryCode":63,"cosmosGeoPoint":121,"geoPoint":125,"contacts":11},"Massachusetts General Hospital","Boston","Massachusetts","02114",{"type":65,"coordinates":122},[123,124],-71.05977,42.35843,{"lat":124,"lon":123},{"facility":127,"status":58,"city":128,"state":129,"zip":130,"country":62,"countryCode":63,"cosmosGeoPoint":131,"geoPoint":135,"contacts":11},"Hospital of the University of Pennsylvania","Philadelphia","Pennsylvania","19104",{"type":65,"coordinates":132},[133,134],-75.16362,39.95238,{"lat":134,"lon":133},{"facility":137,"status":58,"city":138,"state":129,"zip":139,"country":62,"countryCode":63,"cosmosGeoPoint":140,"geoPoint":144,"contacts":11},"University of Pittsburgh Medical Center Montefiore","Pittsburgh","15213",{"type":65,"coordinates":141},[142,143],-79.99589,40.44062,{"lat":143,"lon":142},{"facility":146,"status":58,"city":147,"state":148,"zip":149,"country":62,"countryCode":63,"cosmosGeoPoint":150,"geoPoint":154,"contacts":11},"Baylor Scott and White Research Institute","Dallas","Texas","75246",{"type":65,"coordinates":151},[152,153],-96.80667,32.78306,{"lat":153,"lon":152},{"facility":156,"status":58,"city":157,"state":158,"zip":159,"country":62,"countryCode":63,"cosmosGeoPoint":160,"geoPoint":164,"contacts":11},"VCU Medical Center, Richmond","Richmond","Virginia","23298",{"type":65,"coordinates":161},[162,163],-77.46026,37.55376,{"lat":163,"lon":162},{"facility":166,"status":58,"city":167,"state":168,"zip":169,"country":62,"countryCode":63,"cosmosGeoPoint":170,"geoPoint":174,"contacts":11},"University of Wisconsin","Madison","Wisconsin","53792",{"type":65,"coordinates":171},[172,173],-89.40123,43.07305,{"lat":173,"lon":172},{"facility":176,"status":58,"city":177,"state":11,"zip":11,"country":178,"countryCode":179,"cosmosGeoPoint":180,"geoPoint":184,"contacts":11},"University of Alberta, Edmonton","Edmonton","Canada","CA",{"type":65,"coordinates":181},[182,183],-113.46871,53.55014,{"lat":183,"lon":182},{"facility":186,"status":58,"city":187,"state":11,"zip":11,"country":178,"countryCode":179,"cosmosGeoPoint":188,"geoPoint":192,"contacts":11},"McGill University Health Centre","Montreal",{"type":65,"coordinates":189},[190,191],-73.58781,45.50884,{"lat":191,"lon":190},{"facility":194,"status":58,"city":195,"state":11,"zip":11,"country":178,"countryCode":179,"cosmosGeoPoint":196,"geoPoint":200,"contacts":11},"Toronto General Hospital (TGH)","Toronto",{"type":65,"coordinates":197},[198,199],-79.39864,43.70643,{"lat":199,"lon":198},{"facility":202,"status":58,"city":203,"state":11,"zip":11,"country":178,"countryCode":179,"cosmosGeoPoint":204,"geoPoint":208,"contacts":11},"Vancouver General Hospital","Vancouver",{"type":65,"coordinates":205},[206,207],-123.11934,49.24966,{"lat":207,"lon":206},{"facility":210,"status":58,"city":211,"state":11,"zip":11,"country":212,"countryCode":213,"cosmosGeoPoint":214,"geoPoint":218,"contacts":11},"CHU Lille","Lille","France","FR",{"type":65,"coordinates":215},[216,217],3.05512,50.63391,{"lat":217,"lon":216},{"facility":220,"status":58,"city":221,"state":11,"zip":11,"country":212,"countryCode":213,"cosmosGeoPoint":222,"geoPoint":226,"contacts":11},"Centre de recherche en Biomédecine de Strasbourg","Strasbourg",{"type":65,"coordinates":223},[224,225],7.74553,48.58392,{"lat":225,"lon":224},{"facility":228,"status":58,"city":229,"state":11,"zip":11,"country":230,"countryCode":231,"cosmosGeoPoint":232,"geoPoint":236,"contacts":11},"Dresden Center for Islet Transplantation","Dresden","Germany","DE",{"type":65,"coordinates":233},[234,235],13.73832,51.05089,{"lat":235,"lon":234},{"facility":238,"status":58,"city":239,"state":11,"zip":11,"country":240,"countryCode":241,"cosmosGeoPoint":242,"geoPoint":246,"contacts":11},"IRCCS Ospedale San Raffaele","Milan","Italy","IT",{"type":65,"coordinates":243},[244,245],9.18951,45.46427,{"lat":245,"lon":244},{"facility":248,"status":58,"city":249,"state":11,"zip":11,"country":250,"countryCode":251,"cosmosGeoPoint":252,"geoPoint":256,"contacts":11},"Leiden University","Leiden","Netherlands","NL",{"type":65,"coordinates":253},[254,255],4.49306,52.15833,{"lat":255,"lon":254},{"facility":258,"status":58,"city":259,"state":11,"zip":11,"country":260,"countryCode":261,"cosmosGeoPoint":262,"geoPoint":266,"contacts":11},"Oslo University Hospital","Oslo","Norway","NO",{"type":65,"coordinates":263},[264,265],10.74609,59.91273,{"lat":265,"lon":264},{"facility":268,"status":58,"city":269,"state":11,"zip":11,"country":270,"countryCode":271,"cosmosGeoPoint":272,"geoPoint":276,"contacts":11},"King Abdullah International Medical Research Center (KAIMRC) - Riyadh - Endocrinology","Riyadh","Saudi Arabia","SA",{"type":65,"coordinates":273},[274,275],46.72185,24.68773,{"lat":275,"lon":274},{"facility":278,"status":58,"city":269,"state":11,"zip":11,"country":270,"countryCode":271,"cosmosGeoPoint":279,"geoPoint":281,"contacts":11},"King Faisal Specialist Hospital & Research Centre - Riyadh - Endocrinology",{"type":65,"coordinates":280},[274,275],{"lat":275,"lon":274},{"facility":283,"status":91,"city":284,"state":11,"zip":11,"country":285,"countryCode":286,"cosmosGeoPoint":287,"geoPoint":291,"contacts":11},"Hopiteaux Universitaires de Geneve","Geneva","Switzerland","CH",{"type":65,"coordinates":288},[289,290],6.14569,46.20222,{"lat":290,"lon":289},{"facility":293,"status":58,"city":294,"state":295,"zip":11,"country":296,"countryCode":297,"cosmosGeoPoint":298,"geoPoint":302,"contacts":11},"Churchill Hospital","Headington","Oxford","United Kingdom","UK",{"type":65,"coordinates":299},[300,301],-1.21974,51.75737,{"lat":301,"lon":300},{"facility":304,"status":58,"city":305,"state":11,"zip":11,"country":296,"countryCode":297,"cosmosGeoPoint":306,"geoPoint":310,"contacts":11},"Royal Infirmary of Edinburgh","Edinburgh",{"type":65,"coordinates":307},[308,309],-3.19648,55.95206,{"lat":309,"lon":308},{"facility":312,"status":58,"city":313,"state":11,"zip":11,"country":296,"countryCode":297,"cosmosGeoPoint":314,"geoPoint":318,"contacts":11},"Cardiovascular, Metabolic Medicine and Sciences, King's College London","London",{"type":65,"coordinates":315},[316,317],-0.12574,51.50853,{"lat":317,"lon":316},{"facility":320,"status":58,"city":321,"state":11,"zip":11,"country":296,"countryCode":297,"cosmosGeoPoint":322,"geoPoint":326,"contacts":11},"The Newcastle upon Tyne Hospitals NHS Foundation Trust","Newcastle upon Tyne",{"type":65,"coordinates":323},[324,325],-1.61396,54.97328,{"lat":325,"lon":324},{"type":328,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100422855",false,"NCT04786262","A Safety, Tolerability, and Efficacy Study of VX-880 in Participants With Type 1 Diabetes","A Phase 1\u002F2\u002F3 Study to Evaluate the Safety, Tolerability, and Efficacy of VX-880 in Subjects Who Have Type 1 Diabetes Mellitus With Impaired Hypoglycemic Awareness and Severe Hypoglycemia","Key Inclusion Criteria:\n\n* Clinical history of T1D with \\> 5 years of duration of insulin dependence\n* At least two episodes of documented severe hypoglycemia in the 12 months prior to enrollment\n* Stable diabetic treatment\n* Consistent use of continuous glucose monitor (CGM) for at least 3 months before Screening and willingness to use CGM for the duration of the study\n\nKey Exclusion Criteria:\n\n-Prior islet cell transplant, organ transplant, or cell therapy\n\nOther protocol defined Inclusion\u002FExclusion criteria may apply","ALL","18 Years","65 Years",{"count":339,"type":340},52,"ESTIMATED","INTERVENTIONAL",[343],"PHASE3","This study will evaluate the safety, tolerability and efficacy of VX-880 infusion in participants with Type 1 diabetes (T1D) and impaired awareness of hypoglycemia (IAH) and severe hypoglycemia.",[346,347,348],"Diabetes Mellitus, Type 1","Impaired Hypoglycemic Awareness","Severe Hypoglycemia","2026-06-26",{"date":351,"type":352},"2026-06-30","ACTUAL",{"date":354,"type":352},"2021-03-29",{"date":356,"type":340},"2030-06-30",{"name":5,"class":6},29]