A Multicenter, Prospective, Non-Randomized, Open-Label, Active-Controlled Phase 4 Study to Evaluate the Effectiveness and Safety of Siltartoxatug Injection for Tetanus Prophylaxis Following Injury
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 6,000
- 试验地点
- 1
- 主要终点
- Tetanus protection rate
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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).
研究组 & 干预措施
Siltartoxatug Injection
Participants receiving siltartoxatug for tetanus prophylaxis and meeting eligibility criteria will be assigned to the siltartoxatug group (n=4,000).
干预措施: Siltartoxatug Injection (Drug)
HTIG, TAT, or F(ab')₂
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
干预措施: HTIG/TAT/F(ab')₂ (Drug)
结局指标
主要结局
Tetanus protection rate
时间窗: within 90 days
Tetanus protection rate (1 - tetanus incidence rate) within 90 days post-dosing
Primary Objective
时间窗: within 90 days
Tetanus protection rate (1 - tetanus incidence rate) within 90 days post-dosing
次要结局
- Tetanus protection rate(within 28 days and 130 days)
- Incidence rates of adverse events (AEs) and serious adverse events (SAEs)(within 130 days)
- Secondary Objective(within 28 days)
- Secondary Objective(within 90 days)