A Phase 3 interventional study of GR2001 and HTIG in Tetanus, sponsored by Genrix (Shanghai) Biopharmaceutical Co., Ltd.. Recruiting at 20 sites in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-10-10.
Sponsored by Genrix (Shanghai) Biopharmaceutical Co., Ltd. (part of Chongqing Genrix Biopharmaceutical Co., Ltd) · Phase 3, Interventional, and Prevention
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.
318 studies on the registry are indexed under Tetanus; 29 are open to participants now.
This study's planned enrollment of 582 is above the median of 418 across 280 interventional studies indexed under Tetanus.
Browse Tetanus studies →Genrix (Shanghai) Biopharmaceutical Co., Ltd. is the lead sponsor of 28 studies on the registry; 17 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
If randomized to GR2001, participant will receive a single IM gluteal injection of GR2001
Biological: GR2001
If randomized to HTIG, participant will receive a single IM gluteal injection of HTIG
Biological: HTIG
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.
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.
The increase of anti-tetanus neutralizing antibody titers (∆ titers)
The proportion of participants with an increase of anti-tetanus neutralizing antibody titers (∆ titers) over protective level.
Time frame: Baseline up to 12 hours after receipt of Investigational medicinal product.
The incidence of tetanus
Time frame: Up to 105 days after receipt of Investigational medicinal product.
To evaluate the safety of GR2001
Number of participants with treatment-related adverse events or serious adverse events as assessed by CTCAE v5.0
Time frame: Up to 105 days after receipt of Investigational medicinal product.
To evaluate the peak plasma concentration(Cmax) of GR2001
Time frame: Up to 105 days after receipt of Investigational medicinal product.
To evaluate the Area under the plasma concentration versus time curve (AUC0-last,AUC0-inf) of GR2001
Time frame: Up to 105 days after receipt of Investigational medicinal product.
To evaluate the immunogenicity of GR2001
Time frame: Up to 105 days after receipt of Investigational medicinal product.
Started Sep 2024 (actual). Primary completion is estimated for Dec 2024, 3 months after the start.
Of 54 industry-sponsored phase 3 interventional studies under Tetanus, half reached primary completion within 12 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 21. This study's planned 3 months is below that.
Counting every sponsor, half of 55 studies reached it within 12 months; a quarter within 6 and three quarters within 21.
How these figures are worked out, and which studies are left out of them.
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