A Phase 3 interventional study of GR1801 and Human Rabies Immunoglobulin(HRIG) in Rabies Post-exposure Prophylaxis, sponsored by Genrix (Shanghai) Biopharmaceutical Co., Ltd.. Completed at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-09-25.
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 GR1801 injection with Human Rabies Immunoglobulin(HRIG) in patients with WHO Category 3 rabies exposure.
Patients will receive GR1801 injection or HRIG. Each group will receive rabies vaccine as the WHO Essen regime after Study Drug.
This is a randomized, double-blind, Human Rabies Immunoglobulin(HRIG) controlled Phase III clinical trial evaluating the efficacy, safety, pharmacokinetic and immunogenicity of GR1801 injection as a part of post-exposure prophylaxis (PEP) in patients with WHO Category 3 rabies exposure who have met all inclusion/exclusion criteria for their treatment group.
1200 patients aged 18 and above with WHO Category III rabies exposure should be enrolled as planned and randomly assigned to the experimental group and the control group based on a ratio of 3: 1. The random stratification factors include time of exposure (within or beyond 24 hours), bite location (above or below the neck), and number of bites (1 or more).
All the patients should receive wound infiltration injection of GR1801 or HRIG on Study Day 0 (wound conditions should be described and recorded both before and post injection by photos, including diameter, depth, expansion treatment, etc.), and should also receive intramuscular injection of one dose of the freeze-dried rabies vaccine for human use (Vero cells) into the deltoid muscle after the infiltration injection. Patients should also be given one dose of the freeze-dried rabies vaccine for human use (Vero cells) on Study Days 3, 7, 14, and 28 respectively according to the WHO Essen regime.
Rabies virus neutralizing antibodies (RVNA) should be collected 9 times from each subject prior to administration and on Study Day1, 3, 5, 7, 14, 42, 90, 365 post administration of Study Drug. RVNA should be assayed through rapid fluorescence focus inhibition test (RFFIT). The occurrence of rabies and survival conditions should be collected through every follow-up visit.
Adverse events should be classified in accordance with solicited adverse events and unsolicited adverse events. Solicited adverse events include local adverse events (such as injection sites pain, induration, swelling, redness, rash and pruritus) and systemic adverse events (such as fever, hypersensitivity, headache, fatigue, nausea, vomiting, arthralgia and myalgia). Unsolicited adverse events are those except solicited adverse events or solicited adverse events beyond 7 days after the first administration.
Solicited adverse events should be collected 7 days after the first administration. Unsolicited adverse events should be collected in 3 months after the first administration and serious adverse events(SAE) should be collected throughout the trial.
114 studies on the registry are indexed under Rabies; 15 are open to participants now.
This study's enrollment of 1,200 is above the median of 201 across 104 interventional studies indexed under Rabies.
Browse Rabies studies →Genrix (Shanghai) Biopharmaceutical Co., Ltd. is the lead sponsor of 28 studies on the registry; 17 are open to participants now.
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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 condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
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.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GR1801 injections are administered by wound infiltration injection or by intramuscular injection.GR1801 injections are a bispecific monoclonal antibody that exhibit a wide spectrum of activity against various wild-type rabies strains in vitro. Dosage form:2mg/1mL/vial, liquid, Dosage: 0.05mg/kg of GR1801 Frequency/duration: at Day 0. Rabies vaccine should be administered in deltoid muscle Dosage form: \>=2.5 IU, freeze-dried vaccine, 0.5 mL after reconstitution, Frequency/duration: at Day 0, 3, 7, 14, 28.
Biological: GR1801 · Biological: Rabies Vaccine
HRIG is administered by wound infiltration injection or by intramuscular injection. Dosage form: 200 IU/2mL/vial, liquid, Dosage: 20 IU/kg, Frequency/duration: at Day 0. Rabies vaccine should be administered in deltoid muscle Dosage form: \>=2.5 IU, freeze-dried vaccine, 0.5 mL after reconstitution, Frequency/duration: at Day 0, 3, 7, 14, 28.
Biological: Human Rabies Immunoglobulin(HRIG) · Biological: Rabies Vaccine
The injection solution GR1801 does not contain preservatives. The excipients include histidine/histidine hydrochloride (20mM), trehalose (90 mg/mL), disodium EDTA (0.372mg/mL) and polysorbate 80 (0.5 mg/mL). The pH value is 5.8 and each bottle contains 2mg of GR1801 protein. The packaging material is a borosilicate glass tube injection bottle (2mL) with a halogenated butyl rubber stopper for injection and an aluminum-plastic composite cap for antibiotic bottles.
The HRIG is a Chinese licensed Human Rabies Immunoglobulin produced by BOYA-BIO, which are derived from human plasma, and then purified and filled in the injectable vial form.
The Chinese licensed freeze-dried rabies vaccine produced by CHENGDA PHARMACEUTICALS for human use (Vero Cells) which is indicated for the rabies Post-exposure Prophylaxis (PEP) .
To evaluate the Geometric mean RVNA Concentration (accessd by Rapid Fluorescent Foci Inhibition Test(RIFFIT)) for GR1801 recipients is non-inferior to the Geometric mean RVNA Concentration for HRIG recipients on Study Day 7.
RVNA（Rabies Virus Neutralizing Antibodies） geometric mean concentration of GR1801 recipients and HRIG recipients in combination with rabies vaccines.
Time frame: 7 days
To evaluate the percentage of subjects with RVNA concentration ≥ 0.5 IU/mL on Study Day 14 in GR1801 recipients is non-inferior to the percentage of subjects with RVNA concentration ≥ 0.5 IU/mL for HRIG.
The percentage of subjects with the RVNA geometric mean concentration ≥ 0.5 IU/mL in GR1801 recipients and HRIG recipients in combination with rabies vaccines.
Time frame: 14 days
To evaluate the rabies post-exposure protection rate for GR1801 recipients is non-inferior to the protection rate for HRIG recipients on Study Day 365.
The percentage of subjects with no case of rabies death in GR1801 recipients and HRIG recipients in combination with rabies vaccines.
Time frame: 365 days
To evaluate the rabies post-exposure morbidity of GR1801 compared to HRIG within 90 days and 365 days after administration.
The percentage of subjects with probable or confirmed cases of rabies.
Time frame: 365 days
To evaluate the rabies post-exposure mortality of GR1801 compared to HRIG within 90 days and 365 days after administration.
The percentage of subjects with cases of rabies death.
Time frame: 365 days
To evaluate the rabies post-exposure survival rate of GR1801 compared to HRIG within 90 days and 365 days after administration.
The percentage of subjects with rabies-free survival.
Time frame: 365 days
To evaluate the Geometric mean RVNA Concentration of GR1801 compared to HRIG within 1,3,5,14,42,90 and 365 days after administration.
RVNA geometric mean concentration.
Time frame: 365 days
To evaluate the percentage of subjects with RVNA concentration ≥ 0.5 IU/mL of GR1801 compared to HRIG within 1,3,5,7,42,90 and 365 days after administration.
The percentage of subjects with RVNA geometric mean concentration ≥ 0.5 IU/mL.
Time frame: 365 days
To evaluate the detection rate of RVNA concentration of GR1801 compared to HRIG within 1,3,5,7,14,42,90 and 365 days after administration.
The percentage of subjects whose RVNA geometric mean concentration are below the quantization limit.
Time frame: 365 days
To evaluate the safety of GR1801 compared to HRIG within 365 days.
Number of participants with treatment-related adverse events or serious adverse events as assessed by CTCAE v5.0
Time frame: 365 days
To evaluate the peak plasma concentration(Cmax) of GR1801 within 365 days.
The peak plasma concentration of GR1801 will be estimated at D3,D7,D14 and D42,using non compartmental analysis.
Time frame: 365 days
To evaluate the Area under the plasma concentration versus time curve (AUC0-last,AUC0-inf) of GR1801 within 365 days.
The Area under the plasma concentration versus time curve (AUC0-last,AUC0-inf) of GR1801 will be estimated at D3,D7,D14 and D42,using non compartmental analysis.
Time frame: 365 days
To evaluate the immunogenicity of GR1801 within 365 days.
To assess the anti-drug-antibodies (ADA) and neutralizing antibodies (NAb) of GR1801.
Time frame: 365 days
Plan to share: No
No publications or documents are linked to this record.
Ran from Oct 2022 to primary completion in Sep 2023, 10 months.
Of 19 phase 3 interventional studies under Rabies, half reached primary completion within 15 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 21. This study's 10 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Sep 2023. You cannot join it, but the record below documents what was studied.
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