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A Phase III Clinical Trail to Evaluate the Efficacy, Safety, Pharmacokinetics and Immunogenicity Characteristics of GR2001 Injection
Sponsor: Genrix (Shanghai) Biopharmaceutical Co., Ltd.
Summary
The goal of this clinical trial is to compare the efficacy and safety of GR2001 injection with Human Tetanus Immunoglobulin(HTIG) in tetanus prophylaxis. Patients will receive either GR2001 injection or HTIG on study D0.
Official title: A Multicentre, Randomized, Double-blind, Human Tetanus Immunoglobulin(HTIG) Controlled Phase III Clinical Trail to Evaluate the Efficacy, Safety, Pharmacokinetics and Immunogenicity Characteristics of GR2001 Injection for Indication of Prophylaxis Against Tetanus
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
582
Start Date
2024-09-03
Completion Date
2025-03-04
Last Updated
2024-10-10
Healthy Volunteers
No
Conditions
Interventions
GR2001
The packaging for GR2001 injection uses a borosilicate glass vial, a brominated halobutyl rubber stopper for injectable solutions and an aluminum-plastic combination cap for antibiotic vials as its primary packaging materials. The specification is 5mg/1ml per vial.
HTIG
The HTIG is a Chinese licensed Human Tetanus Immunoglobulin produced by Tonglu-Bio, which are derived from human plasma, and then purified and filled in the injectable vial form.
Locations (20)
The Second Affiliated Hospital of Anhui Medical University
Hefei, Anhui, China
Peking University First Hospital
Beijing, Beijing Municipality, China
Peking University People Hospital
Beijing, Beijing Municipality, China
Beijing Tiantan Hospital
Beijing, Beijing Municipality, China
The First Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, China
The Third Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, China
Zhujiang Hospital Affiliated to Southern Medical University
Guangzhou, Guangdong, China
Shenzhen Second People's Hospital
Shenzhen, Guangdong, China
Liuzhou People's Hospital
Liuchow, Guangxi, China
Liuzhou Workers's Hospital
Liuchow, Guangxi, China
The Affiliated Hospital of Zunyi Medical University
Zunyi, Guizhou, China
The Central Hospital of Wuhan
Wuhan, Hubei, China
Tongji Hospital, Tongji Medical College of HUST
Wuhan, Hubei, China
Nanhua Hospital Affiliated to University of south China
Hengyang, Hunan, China
The Affiliated Hospital of Yangzhou University
Yangzhou, Jiangsu, China
The Second Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, China
Huashan Hospital, Fudan University
Shanghai, Shanghai Municipality, China
Linfen Central Hospital
Linfen, Shanxi, China
Yuncheng Central Hospital
Yuncheng, Shanxi, China
Zhejiang Provincial People's Hospital
Hangzhou, Zhejiang, China