A Study to Assess the Efficacy and Safety of Burfiralimab(hzVSF-v13) and OAD (Oral Antiviral Drug)
Chronic Hepatitis B
About this trial
This is an interventional treatment trial for Chronic Hepatitis B
Eligibility Criteria
Inclusion Criteria: Those who have a history of a diagnosis of chronic hepatitis B more than 24 weeks prior to screening and have been maintaining HBsAg positive at screening Those who have an HBV DNA level that is below <20 IU/mL Those who have been receiving tenofovir (including Tenofovir's salt-free or salt-modifying drugs), or entecarvir (including Entecavir's salt-free or salt-modifying drugs) stably for ≥24 weeks prior to screening and anticipated to maintain the identical drug with equivalent dosage and administration during the clinical trial. Exclusion Criteria: Those with a history of clinically significant chronic liver disease caused by other than chronic HBV infection at the time of screening Patients with a signs of loss of liver function and decompensation of liver disease Patients with uncontrolled diabetes (HbA1c >7.5%) Patients with uncontrolled hypertension
Sites / Locations
- Chung-Ang University HospitalRecruiting
- Samsung Medical CenterRecruiting
- Seoul National University HospitalRecruiting
- Severance HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Placebo Comparator
Experimental
Experimental
Experimental
Placebo to hzVSF-v13
hzVSF-v13 50mg
hzVSF-v13 200mg
hzVSF-v13 800mg
Placebo to match hzVSF-v13 + oral antiviral agent
hzVSF-v13 50 mg/dose + oral antiviral agent
hzVSF-v13 200 mg/dose + oral antiviral agent
hzVSF-v13 800 mg/dose + oral antiviral agent