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A Prospective, Multicenter Study of Siltartoxatug Injection for the Prevention of Post-Traumatic Tetanus

A Prospective, Multicenter Study of Siltartoxatug Injection for the Prevention of Post-Traumatic Tetanus

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600117128
Enrollment
Unknown
Registered
2026-01-20
Start date
2026-01-23
Completion date
Unknown
Last updated
2026-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Tetanus

Interventions

Siltartoxatug Group:Siltartoxatug injection

Sponsors

Fuzhou University Affiliated Provincial Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1..Age >= 18 years and voluntarily signed informed-consent form; 2. Open injury requiring urgent passive immunisation against tetanus.

Exclusion criteria

Exclusion criteria: 1. Low-risk tetanus group or tetanus already manifest; 2. Fever within the past 3 days (body temperature > 38 °C); 3. Severe hepatic or renal disease, high bleeding risk (unless caused by the trauma itself), immunodeficiency or immunosuppression, history of severe allergic reaction; 4. Pregnant or lactating women; 5. Use of any blood product within the past 3 months or participation in another clinical trial; 6. History of psychiatric disorder with current medication.

Design outcomes

Primary

MeasureTime frame
Tetanus antitoxin neutralizing antibody titer;

Secondary

MeasureTime frame
Tetanus protection rate;Occurrence of adverse reactions;

Countries

China

Contacts

Public ContactHe Wubing

Fuzhou University Affiliated Provincial Hospital

hewb120@sina.com+86 591 88217321

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026