[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100533546":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":24,"centralContacts":24,"locations":24,"responsibleParty":27,"collaborators":24,"id":31,"slug":32,"hasResults":33,"nctId":34,"briefTitle":35,"officialTitle":36,"acronym":24,"eligibilityCriteria":37,"healthyVolunteers":33,"sex":38,"minAge":39,"maxAge":40,"enrollmentInfo":41,"targetDuration":24,"studyType":44,"phases":45,"briefSummary":47,"conditions":48,"keywords":24,"overallStatus":50,"whyStopped":24,"lastUpdateSubmitDate":51,"lastUpdatePostDateStruct":52,"startDateStruct":55,"completionDateStruct":57,"leadSponsor":59,"locationsCount":24},{"fullName":5,"class":6},"Second Xiangya Hospital of Central South University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Sorafenib","EXPERIMENTAL","Subjects receive sorafenib 400mg once daily. Insulin therapy will be continued as a routine therapy.",[13],"Drug: Sorafenib",{"label":15,"type":16,"description":17,"interventionNames":18},"Placebo","PLACEBO_COMPARATOR","Subjects receive placebo 400mg once daily. Insulin therapy will be continued as a routine therapy.",[19],"Drug: Placebo",[21,25],{"type":22,"name":9,"description":11,"armGroupLabels":23,"otherNames":24},"DRUG",[9],null,{"type":22,"name":15,"description":17,"armGroupLabels":26,"otherNames":24},[15],{"type":28,"investigatorFullName":29,"investigatorTitle":30,"investigatorAffiliation":5,"oldNameTitle":24,"oldOrganization":24},"PRINCIPAL_INVESTIGATOR","Zhiguang Zhou","Professor","100533546","phase-2-efficacy-and-safety-of-sorafenib-in-new-onset-type-1-diabetes-mellitus-100533546",false,"NCT06227221","Efficacy and Safety of Sorafenib in New-Onset Type 1 Diabetes Mellitus","A Phase 2, Randomized, Placebo Controlled Study Investigating the Efficacy and Safety of Sorafenib in New-Onset Type 1 Diabetes Mellitus","Inclusion Criteria:\n\n1. Subjects with written informed consent;\n2. Age: 18-60 years;\n3. Diagnosis of T1DM according to ADA criteria within 1 year prior to starting study drug;\n4. Islet autoantibody positivity (one or more of GADA, IA-2A, ZnT8A);\n5. Stimulated C-peptide \\> 200 pmol\u002FL;\n6. Participants of childbearing age who are sexually active must agree to use of effective birth control until the end of the study\n\nExclusion Criteria:\n\n1. Non-Type 1 Diabetes Mellitus.\n2. Signs of chronic active infection (e.g., hepatitis, tuberculosis, cytomegalovirus, Epstein-Barr virus, herpes zoster, or toxoplasmosis), or screening laboratory evidence consistent with chronic active infection:\n\n   * Positivity for human immunodeficiency virus\n   * Positive purified protein derivative or interferon-γ release assay suggestive of tuberculosis\n   * Positivity for hepatitis B surface antigen And acute infections (e.g., respiratory, urinary tract, or gastrointestinal infections) must be resolved before reevaluation;\n3. Severe hypertension (systolic blood pressure \\> 200 mmHg and\u002For diastolic blood pressure \\> 110 mmHg, or those requiring the concurrent use of 3 or more antihypertensive medications);\n4. Previous or current cerebro-cardiovascular diseases:\n\n   * Congestive heart failure (NYHA Class III-IV)\n   * Myocardial infarction\n   * unstable ischemic heart disease,\n   * Arrhythmia\n   * Syncope of cardiac or unknown origin\n   * Structural defects\n   * Signs of QT prolongation on electrocardiogram (450 ms in men, 470 ms in women)\n   * Stroke\n   * Transient Ischemic Attack\n5. Hematological conditions:\n\n   * Anemia (hemoglobin below 120 g\u002FL in men and 110 g\u002FL in women)\n   * Leukopenia (\\\u003C4000 leukocytes per μL)\n   * Thrombocytopenia (\\\u003C100,000 platelets per μL)\n   * Neutropenia (\\\u003C1500 neutrophils per μL)\n6. Abnormal coagulation function during the screening period: Prothrombin time (PT) is prolonged beyond the upper limit of normal for 3 seconds and\u002For activated partial thromboplastin time (APTT) is prolonged beyond the upper limit of normal for 10 seconds;\n7. Liver and renal dysfunction:\n\n   * acute or chronic active hepatitis\n   * alanine aminotransferase or aspartate aminotransferase \\>2·0 times the upper limit of normal persisting for persisting for more than one week\n   * impaired renal function defined by estimated glomerular filtration rate (according to the CKD-EPI) of \\\u003C 60 mL\u002Fmin\u002F1.73 m2\n8. History of severe gastrointestinal diseases such as gastrointestinal ulcers, gastrointestinal hemorrhage, pyloric stenosis, gastric bypass surgery, acute or chronic pancreatitis, etc;\n9. Have had any major surgery within 8 weeks prior to screening or will require major surgery during the study;\n10. Anticipated ongoing use of diabetes medications other than insulin;\n11. Known hypersensitivity to sorafenib, or history of severe allergic reactions to other medications (e.g., anaphylaxis, angio-edema, or serious cutaneous drug reactions);\n12. Use of medications in the last month known to cause an ongoing change in the course of type 1 diabetes or immunological status (e.g., high-dose inhaled, extensive topical, or systemic glucocorticoids);\n13. Previous treatment with sorefenib or related multikinase inhibitor;\n14. Concurrent use of medications that affect cytochrome P450 3A4 or use of drugs that interact with sorefenib, leading to altered plasma concentrations of the drugs;\n15. For men: unwilling to adopt contraception during the whole study period;\n16. For women:\n\n    * Pregnancy or breastfeeding\n    * Less than 100 days postpartum before enrollment\n    * Unwilling to defer pregnancy during the 1-year study period\n17. Known coagulation disorders or use of anticoagulants (e.g., warfarin, rivaroxaban, or low molecular weight heparin);\n18. Other situations in which the investigator considers it inappropriate to participate in this trial.","ALL","18 Years","60 Years",{"count":42,"type":43},10,"ESTIMATED","INTERVENTIONAL",[46],"PHASE2","The purpose of this study is to investigate the therapeutic effect and safety of Sorafenib in T1DM patients.",[49],"Type 1 Diabetes","NOT_YET_RECRUITING","2026-02-09",{"date":53,"type":54},"2026-02-12","ACTUAL",{"date":56,"type":43},"2026-02",{"date":58,"type":43},"2029-06",{"name":5,"class":6}]