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Huang","18981838236","huangxiaobing@med.uestc.edu.cn",{"type":142,"investigatorFullName":29,"investigatorTitle":29,"investigatorAffiliation":29,"oldNameTitle":29,"oldOrganization":29},"SPONSOR","100639052",false,"NCT07579949","A Study of SNH-119014 in Adult Participants With Non-transfusion-dependent Thalassemia (NTDT)","A Phase 2 Study to Determine the Safety, Efficacy, Pharmacokinetics, and Pharmacodynamics of SNH-119014 in Adult Subjects With Non-transfusion-dependent Thalassemia","Inclusion Criteria:\n\n* Male or Female;\n\n  -≥18 years;\n* Documented diagnosis of thalassemia;\n* Non-transfusion-dependent;\n* Hb concentration ≤10.0 grams per deciliter (g\u002FdL) during the screening period;\n* For women of reproductive potential: negative serum pregnancy test during the screening period;\n* Agreement to use approved contraceptive measures;\n* Informed consent;\n\nExclusion Criteria:\n\n* Hemoglobin S forms of thalassemia;\n* History of Congestive Heart Failure Within 6 months prior to signed informed consent;\n* Myocardial Infarction\u002Funstable angina Within 6 months prior to signed informed consent;\n* Deep Vein Thrombosis\u002Fstroke\u002Fthromboembolic events Within 6 months prior to signed informed consent;\n* Poorly controlled hypertension or diabetes;\n* Markedly abnormal QTcF interval;\n* Severe arrhythmia requiring treatment as assessed by the investigator;\n* Markedly abnormal left ventricular ejection fraction;\n* Diagnosis of any other congenital or acquired hematologic disorder, or any other hemolytic process;\n* Active infection requiring intravenous antibiotics or of Grade ≥3 severity within 4 weeks prior to the first dose;\n* History of primary malignancy, except for: cured non-melanoma skin cancer; curatively treated cervical or breast carcinoma in situ; or other primary tumors treated with curative intent with no known active disease and no treatment in the past 5 years;\n* History of neurological or psychiatric disorders that, in the investigator's assessment, may affect the participant's ability to participate in the clinical study;\n* Post-splenectomy sepsis;\n* Severe pulmonary disease or hepatobiliary disease;\n* Abnormal laboratory tests during screening;\n* Use of luspatercept, hydroxyurea, erythropoietin, strong CYP3A4 inhibitors, or strong CYP3A4 inducers within the prohibited period specified in the protocol;\n* Receipt of anticoagulant therapy prior to screening, or requirement for anticoagulant therapy during the study period;\n* Prior bone marrow or stem cell transplant;\n* Pregnant or lactating women;\n* Major surgery within 6 months prior to signing informed consent or planned during the study period;\n* Splenectomy scheduled during the study treatment period;\n* Participation in another clinical trial and receipt of investigational treatment within 3 months;\n* History of severe allergy, or allergy to SNH-119014 or its excipients;\n* Any other condition that, in the investigator's opinion, makes the participant unsuitable for enrollment.","ALL","18 Years",{"count":152,"type":153},30,"ESTIMATED","INTERVENTIONAL",[156],"PHASE2","This study is a multicenter study to evaluate the safety, efficacy, pharmacokinetics, and pharmacodynamics of treatment with SNH-119014 in adult participants with non-transfusion-dependent thalassemia. 30 participants with non-transfusion-dependent thalassemia were enrolled.",[159],"Thalassemia","NOT_YET_RECRUITING","2026-05-06",{"date":163,"type":164},"2026-05-12","ACTUAL",{"date":166,"type":153},"2026-06-18",{"date":168,"type":153},"2027-04-29",{"name":5,"class":6},8]