A Phase 4 Study to Evaluate the Effectiveness and Safety of Siltartoxatug Injection for Tetanus Prophylaxis Following Injury
NCT ID: NCT07347938
Last Updated: 2026-01-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
6000 participants
OBSERVATIONAL
2026-01-05
2029-03-31
Brief Summary
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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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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Siltartoxatug Injection
Participants receiving siltartoxatug for tetanus prophylaxis and meeting eligibility criteria will be assigned to the siltartoxatug group (n=4,000).
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
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
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.
Interventions
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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
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* Severe cognitive impairment or other condition interfering with the assessment of tetanus development.
* Currently participating in another interventional clinical trial (observational studies are permitted).
18 Years
ALL
No
Sponsors
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Zhuhai Trinomab Pharmaceutical Co., Ltd.
INDUSTRY
Responsible Party
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Locations
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The Second Affiliated Hospital Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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TNM002-401
Identifier Type: -
Identifier Source: org_study_id
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