Menu
Not yet recruiting NCT07579949

A Study of SNH-119014 in Adult Participants With Non-transfusion-dependent Thalassemia (NTDT)

Phase II Interventional Thalassemia

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: SNH-119014 dose 1, SNH-119014 dose 2, Placebo.
Who it may be relevant to
Registry conditions: Thalassemia. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Phase 2 Study to Determine the Safety, Efficacy, Pharmacokinetics, and Pharmacodynamics of SNH-119014 in Adult Subjects With Non-transfusion-dependent Thalassemia

Overview

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.

Interventions

  • Drug SNH-119014 dose 1
    Study Drug
  • Drug SNH-119014 dose 2
    Study Drug
  • Drug Placebo
    Placebo

Primary outcome measures

  • Safety evaluation [Time frame: From signing the informed consent to 4 weeks after the last dose]

Eligibility criteria

Inclusion criteria

  • 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 criteria

  • Hemoglobin S forms of thalassemia;
  • 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;
  • Poorly controlled hypertension or diabetes;
  • Markedly abnormal QTcF interval;
  • Severe arrhythmia requiring treatment as assessed by the investigator;
  • Markedly abnormal left ventricular ejection fraction;
  • Diagnosis of any other congenital or acquired hematologic disorder, or any other hemolytic process;
  • 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;
  • History of neurological or psychiatric disorders that, in the investigator's assessment, may affect the participant's ability to participate in the clinical study;
  • Post-splenectomy sepsis;
  • Severe pulmonary disease or hepatobiliary disease;
  • Abnormal laboratory tests during screening;
  • 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;
  • Pregnant or lactating women;
  • Major surgery within 6 months prior to signing informed consent or planned during the study period;
  • Splenectomy scheduled during the study treatment period;
  • Participation in another clinical trial and receipt of investigational treatment within 3 months;
  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Treatment

Study locations

China · 8 centers
  • Foshan First People's Hospital — Foshan
  • Nanfang Hospital, Southern Medical University — Guangzhou
  • Maoming People's Hospital — Maoming
  • Liuzhou People's Hospital — Liuzhou
  • 923rd Hospital of the Joint Logistics Support Force of the People's Liberation Army of Chi — Nanning
  • The First Affiliated Hospital of Guangxi Medical University — Nanning
  • The First Affiliated Hospital of Hainan Medical University — Haikou
  • Sichuan Academy of Medical Sciences & Sichuan Provincial People's Hospital — Chengdu

Identifiers

NCT: NCT07579949 · SNH-119014-II-01

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗