A Phase 4 Study to Evaluate the Effectiveness and Safety of Siltartoxatug Injection for Tetanus Prophylaxis Following Injury
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: Siltartoxatug Injection, HTIG/TAT/F(ab')₂.
- Who it may be relevant to
- Registry conditions: Tetanus. 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 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
Overview
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.
Interventions
- Drug Siltartoxatug Injection
Dosage form: Injectable solution Strength: 10 mg / 0.5 mL per vial Route and regimen: Single intramuscular injection in the gluteal muscle at a dose of 10 mg - Drug HTIG/TAT/F(ab')₂
Dosage form, strength, and administration: As specified in the respective product's approved labeling (package insert). All use will follow routine clinical practice per local guidelines.
Primary outcome measures
- Tetanus protection rate [Time frame: within 90 days]
Secondary outcome measures (2)
- Tetanus protection rate [Time frame: within 28 days and 130 days]
- Incidence rates of adverse events (AEs) and serious adverse events (SAEs) [Time frame: within 130 days]
Eligibility criteria
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).
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
China · 1 center
- The Second Affiliated Hospital Zhejiang University School of Medicine — Hangzhou
Identifiers
NCT: NCT07347938 · TNM002-401