drugset / Trial / NCT05808335
A Study to Assess the Efficacy and Safety of Burfiralimab(hzVSF-v13) and OAD (Oral Antiviral Drug)
RandomizedParallel-groupDouble-blindTreatment
Summary
This is a multicenter, randomized, double-blind, parallel group, 48-week follow-up, Phase IIa clinical study. This study has been designed to evaluate the change in HBsAg (log10 IU/mL) after administration of hzVSF-v13 50 mg/dose and hzVSF-v13 200 mg/dose in combination with an oral antiviral agent (Tenofovir or entecavir, including salt-free or salt-modifying drugs) compared to an oral antiviral agent in combination with a placebo (normal saline) in patients with chronic hepatitis B who are stably receiving an oral antiviral agent (Tenofovir or entecavir, including salt-free or salt-modifying drugs) for at least 24 weeks.
Timeline
- Start
- 2022-01-11
- Primary completion
- 2024-03-27
- Completion
- 2024-12-04
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Burfiralimab | Monoclonal antibody | 50 mg | Intravenous |
| Subject | Burfiralimab | Monoclonal antibody | 200 mg | Intravenous |
| Subject | Burfiralimab | Monoclonal antibody | 800 mg | Intravenous |
| Background | Entecavir | Small molecule | — | Oral |
| Background | Tenofovir | Small molecule | — | Oral |