NCT05808335

A Study to Assess the Efficacy and Safety of Burfiralimab(hzVSF-v13) and OAD (Oral Antiviral Drug)

A Phase IIa Multi-center, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Oral Antiviral Agents/hzVSF-v13 Combination Therapy vs Oral Antiviral Monotherapy in Chronic Hepatitis B Patients

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 32 (estimated)
• Sponsor: ImmuneMed, Inc. · Industry
• Sex: All
• Age: 19 Years – 64 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Among the subjects who provided a voluntary written consent to participate in this clinical study, the 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 prior to the screening visit can be considered as potential subjects of this study. Only the subjects who completed the final eligibility evaluation at the baseline visit (Visit 2) after the screening tests will be randomized to the hzVSF-v13 50 mg combination group, hzVSF-v13 200 mg combination group (study group) and placebo combination group (control group) at a 1:1:1 ratio at each site. The randomized subjects will receive intravenous administration of hzVSF-v13 or the placebo to match hzVSF-v13 four times with 4 weeks interval for a total of 12 weeks, and oral administration of 1 tablet of an oral antiviral agent will be given once daily for a total of 48 weeks.

Conditions

• Chronic Hepatitis B

Interventions

Type	Name	Description
DRUG	Standard of care	The following medications listed are allowed to be administered during the course of the clinical study. 1. Tenofovir (including salt-free or salt-modifying drugs) 2. Entecavir (including salt-free or salt-modifying drugs)

Timeline

• Start date: 2022-01-11
• Primary completion: 2024-03-27
• Completion: 2024-12-04
• First posted: 2023-04-11
• Last updated: 2023-06-15

Locations

4 sites across 1 country: South Korea