Clinical trial NCT05808335: A Study to Assess the Efficacy and Safety of Burfiralimab(hzVSF-v13) and OAD (Oral Antiviral Drug)
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Chronic Hepatitis B
Lead sponsor: ImmuneMed, Inc.
Sponsor class: INDUSTRY
First posted: 2023-04-11
Enrollment: 32
Sex: ALL
Minimum age (years): 19
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: Inclusion Criteria:

1. 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
2. Those who have an HBV DNA level that is below \<20 IU/mL
3. 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:

1. Those with a history of clinically significant chronic liver disease caused by other than chronic HBV infection at the time of screening
2. Patients with a signs of loss of liver function and decompensation of liver disease
3. Patients with uncontrolled diabetes (HbA1c \>7.5%)
4. Patients with uncontrolled hypertension

Primary outcomes:
measure: Change in HBsAg from the baseline at 24 weeks (log10 IU/mL)
timeFrame: 24 weeks
Secondary outcomes:
measure: Percentage of subjects with HBsAg loss or seroconversion compared to the baseline at 8, 12, 24 and 48 weeks
timeFrame: 8, 12, 24, 48 weeks
measure: Percentage of subjects with HBV DNA lower than the lower limit of quantification (LLOQ) compared to the baseline at 24 and 48 weeks
timeFrame: 24, 48 weeks
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Chung-Ang University Hospital
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Seoul
country: Korea, Republic of
facility: Severance Hospital
Study officials:
affiliation: Samsung Medical Center
name: Joon Hyeok Lee, M.D. Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: