Testing SNH-119014 in Adults With Non-transfusion-dependent Thalassemia
Tests SNH-119014 against placebo in adults with non-transfusion-dependent thalassemia.
Plain-language title generated from the registry record
Registry title: A Study of SNH-119014 in Adult Participants With Non-transfusion-dependent Thalassemia (NTDT)
Key facts
- Where
- Chengdu, Foshan, Guangzhou, Haikou, Liuzhou, Maoming, and Nanning, ChinaSee the 8 sites
- Phase
- Phase 2
Where in China
- Sichuan Academy of Medical Sciences sichuan Provincial People's HospitalChengdu, ChinaNo longer taking part
- Foshan First People's HospitalFoshan, ChinaNo longer taking part
- Nanfang Hospital, Southern Medical UniversityGuangzhou, ChinaNo longer taking part
- The First Affiliated Hospital of Hainan Medical UniversityHaikou, ChinaNo longer taking part
- Liuzhou People's HospitalLiuzhou, ChinaNo longer taking part
- Maoming people's hospitalMaoming, ChinaNo longer taking part
- 923rd Hospital of the Joint Logistics Support Force of the People's Liberation Army of ChinaNanning, ChinaNo longer taking part
- The First Affiliated Hospital of Guangxi Medical UniversityNanning, ChinaNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- ScinnoHub Pharmaceutical Co., Ltd.
- Trial code
- NCT07579949
- Record updated
- 12 May 2026
- Original description
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.Read full original descriptionShow less
A Phase 2 Study to Determine the Safety, Efficacy, Pharmacokinetics, and Pharmacodynamics of SNH-119014 in Adult Subjects With Non-transfusion-dependent Thalassemia
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.
Inclusion: Male or Female; -≥18 years; Documented diagnosis of thalassemia; Non-transfusion-dependent; Hb concentration ≤10.0 grams per deciliter (g/dL) during the screening period; For women of reproductive potential: negative serum pregnancy test during the screening period; Agreement to use approved contraceptive measures; Informed consent.
Exclusion: History of Congestive Heart Failure Within 6 months prior to signed informed consent; Myocardial Infarction/unstable angina Within 6 months prior to signed informed consent; Deep Vein Thrombosis/stroke/thromboembolic events Within 6 months prior to signed informed consent; Active infection requiring intravenous antibiotics or of Grade ≥3 severity within 4 weeks prior to the first dose; 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; Use of luspatercept, hydroxyurea, erythropoietin, strong CYP3A4 inhibitors, or strong CYP3A4 inducers within the prohibited period specified in the protocol; Receipt of anticoagulant therapy prior to screening, or requirement for anticoagulant therapy during the study period; Prior bone marrow or stem cell transplant; Major surgery within 6 months prior to signing informed consent or planned during the study period; Poorly controlled hypertension or diabetes; Severe arrhythmia requiring treatment as assessed by the investigator; Diagnosis of any other congenital or acquired hematologic disorder, or any other hemolytic process; History of neurological or psychiatric disorders that, in the investigator's assessment, may affect the participant's ability to participate in the clinical study; Severe pulmonary disease or hepatobiliary disease; History of severe allergy, or allergy to SNH-119014 or its excipients; Any other condition that, in the investigator's opinion, makes the participant unsuitable for enrollment; Hemoglobin S forms of thalassemia; Markedly abnormal left ventricular ejection fraction; Abnormal laboratory tests during screening; Markedly abnormal QTcF interval; Post-splenectomy sepsis; Pregnant or lactating women; Splenectomy scheduled during the study treatment period; Participation in another clinical trial and receipt of investigational treatment within 3 months.