A Registry: Siltartoxatug Injection for Tetanus Prophylaxis Following Injury

NCT ID: NCT07107932

Last Updated: 2026-01-06

Study Results

Results pending

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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Recruitment Status

RECRUITING

Total Enrollment

10000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-07-31

Study Completion Date

2029-03-30

Brief Summary

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The injury and wound conditions of the enrolled patients will be documented. A follow-up at 90 days post-administration will determine the clinical outcome of tetanus prophylaxis, specifically whether tetanus occurred. The registry will also employ selective safety data collection to record adverse reactions and serious adverse events following Siltartoxatug adminstration.

Detailed Description

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Conditions

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Tetanus

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Siltartoxatug Injection (Brand name: Sintetol®)

Siltartoxatug Injection (Brand name: Sintetol®)

Intervention Type DRUG

The injury and wound conditions of the enrolled patients will be documented. A follow-up at 90 days post-administration will determine the clinical outcome of tetanus prophylaxis, specifically whether tetanus occurred. The registry will also employ selective safety data collection to record adverse reactions and serious adverse events following Siltartoxatug adminstration.

Interventions

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Siltartoxatug Injection (Brand name: Sintetol®)

The injury and wound conditions of the enrolled patients will be documented. A follow-up at 90 days post-administration will determine the clinical outcome of tetanus prophylaxis, specifically whether tetanus occurred. The registry will also employ selective safety data collection to record adverse reactions and serious adverse events following Siltartoxatug adminstration.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 1.Having received or will receive Siltartoxatug for tetanus prophylaxis following injury;
* 2\. Provided signed informed consent by themselves or their legal representatives.

Exclusion Criteria

* None
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Zhuhai Trinomab Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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The Second Affiliated Hospital of Shantou University

Shantou, Guangdong, China

Site Status NOT_YET_RECRUITING

Xiangyun County People's Hospital

Xiangyun, Yunnan, China

Site Status NOT_YET_RECRUITING

Shaoxing Central Hospital

Shaoxing, Zhejiang, China

Site Status RECRUITING

Zhoushan Putuo District People's Hospital

Zhoushan, Zhejiang, China

Site Status NOT_YET_RECRUITING

Countries

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China

Central Contacts

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Xia Qu, Master

Role: CONTACT

+86 0756 726399

xinyu Liu, Doctor

Role: CONTACT

+86 0756 7263999

Facility Contacts

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Tianliang Huang, Doctor

Role: primary

+86 13531168261

Yuanzuo Zhang

Role: primary

+86 13769215316

Liyun Wang

Role: primary

+86 0575-85580999

Li Hu

Role: primary

+86 0580-3030785

Other Identifiers

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TNM002-402

Identifier Type: -

Identifier Source: org_study_id

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