Clinical Research Directory
Browse clinical research sites, groups, and studies.
A Phase 4 Study to Evaluate the Effectiveness and Safety of Siltartoxatug Injection for Tetanus Prophylaxis Following Injury
Sponsor: Zhuhai Trinomab Pharmaceutical Co., Ltd.
Summary
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.
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
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
OBSERVATIONAL
Enrollment
6000
Start Date
2026-01-05
Completion Date
2029-03-31
Last Updated
2026-01-16
Healthy Volunteers
No
Conditions
Interventions
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.
Locations (1)
The Second Affiliated Hospital Zhejiang University School of Medicine
Hangzhou, Zhejiang, China