[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"impaired-hypoglycemic-awareness\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:impaired-hypoglycemic-awareness":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,43],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":42},"100422855","phase-3-a-safety-tolerability-and-efficacy-study-of-vx-880-in-participants-with-type-1-diabetes-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":20,"type":21},52,"ESTIMATED","INTERVENTIONAL",[24],"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.",[27,28,29],"Diabetes Mellitus, Type 1","Impaired Hypoglycemic Awareness","Severe Hypoglycemia","RECRUITING","2026-06-26",{"date":33,"type":34},"2026-06-30","ACTUAL",{"date":36,"type":34},"2021-03-29",{"date":38,"type":21},"2030-06-30",{"name":40,"class":41},"Vertex Pharmaceuticals Incorporated","INDUSTRY",29,{"id":44,"slug":45,"hasResults":11,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":4,"eligibilityCriteria":49,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":50,"enrollmentInfo":51,"targetDuration":4,"studyType":22,"phases":53,"briefSummary":56,"conditions":57,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":58,"lastUpdatePostDateStruct":59,"startDateStruct":61,"completionDateStruct":63,"leadSponsor":65,"locationsCount":68},"100602696","phase-1-a-safety-tolerability-and-efficacy-study-of-e-islet-01-in-participants-with-type-1-diabetes-100602696","NCT07126873","A Safety, Tolerability, and Efficacy Study of E-islet 01 in Participants With Type 1 Diabetes","A Phase 1\u002F2a Study to Evaluate the Safety, Tolerability, and Efficacy of E-islet 01 in Subjects Who Have Type 1 Diabetes Mellitus With Impaired Hypoglycemic Awareness and Severe Hypoglycemia","Inclusion Criteria:\n\n* Clinical history of Type 1 Diabetes with \\> 5 years of duration\n* 2-hour C-peptide level \\\u003C0.3 ng\u002FmL after a mixed meal stimulation test\n* Under continuous insulin therapy, Participants have at least one of the following conditions:\n\n  1. At least one episode of documented severe hypoglycemia in the 12 months prior to enrollment;\n  2. Unaware hypoglycemia evaluated using the Clarke scoring system\n* Willing and able to conduct self-blood glucose monitoring as required, with good compliance\n* Voluntarily participate and sign the informed consent form\n\nExclusion Criteria:\n\n* Uncontrolled systemic infections, including but not limited to pulmonary tuberculosis, active hepatitis, a history of positive hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV-Ab), human immunodeficiency virus antibody (HIV-Ab), or Treponema pallidum antibody (TP-Ab).\n* History of malignancy within the past 5 years or undergoing antitumor treatment\n* Participation in other clinical trials in the 3 months or islet cell transplant, organ transplant, or cell therapy in the 12 months prior to enrollment\n* Other situations judged by the investigator as unsuitable for participation in the trial","75 Years",{"count":52,"type":21},21,[54,55],"PHASE1","PHASE2","This study will evaluate the safety, tolerability and efficacy of E-islet 01 in participants with Type 1 diabetes mellitus (T1D) and impaired awareness of hypoglycemia (IAH) and severe hypoglycemia",[27,28,29],"2025-08-17",{"date":60,"type":34},"2025-08-22",{"date":62,"type":21},"2025-08-11",{"date":64,"type":21},"2029-12-31",{"name":66,"class":67},"EndoCell Therapeutics, Inc.","OTHER",1]