A Phase III Clinical Study to Evaluate SYN023's Efficacy and Safety (NCT04644484) | Clinical Trial Compass
CompletedPhase 3
A Phase III Clinical Study to Evaluate SYN023's Efficacy and Safety
China1,000 participantsStarted 2020-09-23
Plain-language summary
This is a Phase 3, blinded, randomized study of SYN023 compared to a China licensed Human Rabies Immunoglobulin (a Rabies immune globulin from human sources, HRIG) for the prevention of rabies as part of post-exposure prophylaxis (PEP). The trial will enroll the World Health Organization (WHO) Category III rabies exposure subjects. The subject's death and rabies data will be reviewed by Data and safety monitoring board (DSMB) to confirm the safety. Besides, rabies vaccine would be administered after Study Drug in each group.
This trial is proposed to further the licensure of SYN023 to provide an effective PEP alternative available to those exposed persons who need such a product. A placebo-controlled rabies trial is unethical thus HRIG is selected as the control group. Rabies immune globulin from equine and human sources (HRIG) have been evaluated in many trials and HRIG is the standard of care in China.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Is age ≥18 years, on Study Day 1 with legal identification documents, and plan to live in the local administration area during the study;
✓. Category III rabies exposure within 24 hours before Study Drug receipt ;
✓. Completed written informed consent process, and signed the informed consent forms;
✓. Subjects with the ability to understand the study procedure. And agreed to complete all follow-ups;
✓. Female subjects are not in pregnancy (with negative results of urine pregnancy tests before vaccination) and are not in the period of breast feeding, and agree to avoid pregnancy within 121 days after administration;
✓. Those who have an armpit temperature ≤ 37.0 °C.
Exclusion criteria
✕. Previous receipt of equine or human (rabies) globulin or rabies vaccination prior to randomization;
✕. Clinical evidence of rabies infection;
✕. Category I and Category II rabies exposure;
What they're measuring
1
Rabies Virus Neutralizing Activity (RVNA) of Geometric Mean Concentration (GMC) at Study Day 8
✕. Had fever (armpit temperature ≥ 38.5 °C) within 3 days before Study Day 1, or in the acute episode of any chronic diseases;
✕. Received immunoglobulin or blood products (except for the anti-tetanus immunoglobulin) within 43 days before Study Day 1, or plan to use any such product (except for the anti-tetanus immunoglobulin) during the study;
✕. Received systemic immunosuppressant medication such as systemic corticosteroids but not limited to systemic corticosteroids within 43 days before Study Day 1;
✕. History of any immunodeficiency disease (for example: AIDS, systemic lupus erythematosus, etc.); or Laboratory evidence of previous or current immunodeficiency disease, including, but not limited to, any laboratory evidence of HIV infection;
✕. History of spleen function deficiency or function injury, such as no spleen caused by any cause (such as splenectomy);