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A Phase 4 Study to Evaluate the Effectiveness and Safety of Siltartoxatug Injection for Tetanus Prophylaxis Following Injury

Recruitingn/aAges 18 Years - anyAllZhuhai Trinomab Pharmaceutical Co., Ltd.
NCT07347938 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

Study sites were selected from hospitals across diverse regions of China. Approximately 6,000 participants who require passive immunization against tetanus due to various injuries (including those with severe wounds or heavily contaminated injuries) will be enrolled per clinical practice: Participants receiving siltartoxatug for tetanus prophylaxis and meeting eligibility criteria will be assigned to the siltartoxatug group (n=4,000); Participants receiving other passive immunizing agents (HTIG, TAT, or F(ab')₂) for tetanus prophylaxis and meeting eligibility criteria will be assigned to the control group (n=2,000), comprising approximately 1,000 HTIG recipients and 1,000 TAT/F(ab')₂ recipients. All clinical management decisions, including concomitant tetanus vaccination, will be made by investigators per standard clinical practice at each center.

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📋 Eligibility rules (as published)
Inclusion Criteria: * Male or female aged ≥18 years. * Receiving siltartoxatug for tetanus prophylaxis per its approved labeling, or receiving another passive immunizing agent (human tetanus immunoglobulin \[HTIG\], tetanus antitoxin \[TAT\], or equine F(ab')₂ fragment \[F(ab')₂\]) for tetanus prophylaxis per its labeling. * Receiving or planned to receive standard wound management. * Providing written informed consent by the subject or their legally authorized representative. Exclusion Criteria: * Life expectancy \<3 months. * Severe cognitive impairment or other condition interfering with the assessment of tetanus development. * Currently participating in another interventional clinical trial (observational studies are permitted).
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What it tests

  • Siltartoxatug Injection
  • HTIG/TAT/F(ab')₂
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Where

1 site
The Second Affiliated Hospital Zhejiang University School of Medicine
Hangzhou, China
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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