Study to Evaluate GR1801's Efficacy and Safety
- Summary
- 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.
- Short title
- Study to Evaluate GR1801's Efficacy and Safety
- Official title
- A Phase III Clinical Trail to Evaluate the Efficacy,safety,pharmacokinetics and Immunogenicity Characteristics of GR1801 Injection for the Post-exposure Prophylaxis (PEP) of WHO Category 3 Rabies Exposure Patients.
- Control arm
- Active comparator
- Registry reports results
- Listing at source
- Listed
- Recruitment status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Completion date
- 2024-09-06
- First posted
- 2023-05-06
- Registry last updated
- 2024-09-25
- Primary completion date
- 2023-09-06
- Start date
- 2022-10-21
- Actual participants
- 1,200
- Participants
- 1,200
- Participant count basis
- Actual
- Protocol amendments
- Number of sites
- Data monitoring committee
- Registry sponsor category
- Industry
- Lead sponsor
- Genrix (Shanghai) Biopharmaceutical Co., Ltd.
- Source registry
- ClinicalTrials.gov
- Registry ID
- NCT05846568
- ClinicalTrials.gov ID
- NCT05846568
- Registry record
- Open registry record
- Allocation
- Randomised
- Model
- Parallel groups
- Purpose
- Prevention
- Masking
- Quadruple masking
- Masking description
- double blind
- Masked roles
- Participants, Care providers, Investigators, Outcome assessors
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.
Timeframe: 7 days
RVNA（Rabies Virus Neutralizing Antibodies） geometric mean concentration of GR1801 recipients and HRIG recipients in combination with rabies vaccines.
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.
Timeframe: 14 days
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.
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.
Timeframe: 365 days
The percentage of subjects with no case of rabies death in GR1801 recipients and HRIG recipients in combination with rabies vaccines.
To evaluate the rabies post-exposure morbidity of GR1801 compared to HRIG within 90 days and 365 days after administration.
Timeframe: 365 days
The percentage of subjects with probable or confirmed cases of rabies.
To evaluate the rabies post-exposure mortality of GR1801 compared to HRIG within 90 days and 365 days after administration.
Timeframe: 365 days
The percentage of subjects with cases of rabies death.
To evaluate the rabies post-exposure survival rate of GR1801 compared to HRIG within 90 days and 365 days after administration.
Timeframe: 365 days
The percentage of subjects with rabies-free survival.
To evaluate the Geometric mean RVNA Concentration of GR1801 compared to HRIG within 1,3,5,14,42,90 and 365 days after administration.
Timeframe: 365 days
RVNA geometric mean concentration.
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.
Timeframe: 365 days
The percentage of subjects with RVNA geometric mean concentration ≥ 0.5 IU/mL.
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.
Timeframe: 365 days
The percentage of subjects whose RVNA geometric mean concentration are below the quantization limit.
To evaluate the safety of GR1801 compared to HRIG within 365 days.
Timeframe: 365 days
Number of participants with treatment-related adverse events or serious adverse events as assessed by CTCAE v5.0
To evaluate the peak plasma concentration(Cmax) of GR1801 within 365 days.
Timeframe: 365 days
The peak plasma concentration of GR1801 will be estimated at D3,D7,D14 and D42,using non compartmental analysis.
To evaluate the Area under the plasma concentration versus time curve (AUC0-last,AUC0-inf) of GR1801 within 365 days.
Timeframe: 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.
To evaluate the immunogenicity of GR1801 within 365 days.
Timeframe: 365 days
To assess the anti-drug-antibodies (ADA) and neutralizing antibodies (NAb) of GR1801.
- Sex
- All
- Age groups
- Adults, Older adults
- Minimum age
- 18 Years
- Healthy volunteers
- No
- Chinese males or females aged 18 years or above on Study Day 0 with legal identification documents and plan to live in the local area during the study;
- WHO Category III rabies exposure；
- Those who have an armpit temperature ≤ 37.0 °C；
- Completed written informed consent process, signed the informed consent forms and Agreed to complete all follow-ups.
- WHO Category III rabies exposure but received wound suture treatment;
- WHO Category III rabies exposure over 72 hours;
- Previous receipt of rabies vaccination or rabies passive immunization;
- History of bitten by animals such as dogs, cats, bats etc. within the 6 months before the Study Day 0;
- History of any severe allergy for vaccination;
- Had fever (armpit temperature ≥ 38.5 °C) or received any antipyretic, analgesic or anti-allergic drug within 3 days before Study Day 0;
- History of severe autoimmune diseases;
- History of any severe neurological disease；
- History of receiving any immunoglobulin or vaccine within 30 days before Study Day 0, or plan to use any such product during the study;
- History of addiction to any narcotic, alcohol or drugs;
- Previous receipt of any study product (drug, vaccine, biological product or device) within 6 months before Study Day 0, or plan to participate in any other clinical study during this study period;
- Females who are pregnant or with urine pregnancy test positive.
- Center for Disease Control and Prevention (CDC)Kunming, China