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

StatusRecruiting
PhaseNot specified
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary endpoint reworded 1 of 1 changed
See other at-risk trials from Zhuhai Trinomab Pharmaceutical Co., Ltd.

Record History

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  1. Primary endpoint(s) modifiedv2 Show 4 more changesShow less
    • Recruitment opened
    • Start date changed from estimate of Jan 5, 2026 to Jan 14, 2026
    • Secondary endpoints revised (2)
    • Site details revised
  2. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07347938
Lead Sponsor Zhuhai Trinomab Pharmaceutical Co., Ltd.
Conditions
(from sponsor)		 Tetanus
Related terms Tetanus
Enrollment 6,000 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov