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

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.

Study Overview

• Status: Recruiting
• Conditions: Chronic Hepatitis B
• Intervention / Treatment: Drug: Standard of care

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.

• Study Type: Interventional
• Enrollment (Estimated): 32
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Sungman Park, Ph.D.; Phone Number: 6563 82-33-258-6563; Email: smpark@immunemed.co.kr

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Recruiting
    • Seoul National University Hospital
    • Contact: Yoon Jun Kim, M.D. Ph.D.
  • Seoul, Korea, Republic of
    • Recruiting
    • Severance Hospital
    • Contact: Do Young Kim, M.D. Ph.D.
  • Seoul, Korea, Republic of
    • Recruiting
    • Samsung Medical Center
    • Contact: Joon Hyeok Lee, M.D. Ph.D.
  • Seoul, Korea, Republic of
    • Recruiting
    • Chung-Ang University Hospital
    • Contact: Hyung Jun Kim, M.D. Ph.D.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo to hzVSF-v13; Placebo to match hzVSF-v13 + oral antiviral agent	Drug: Standard of care; The following medications listed are allowed to be administered during the course of the clinical study.; Tenofovir (including salt-free or salt-modifying drugs); Entecavir (including salt-free or salt-modifying drugs)
Experimental: hzVSF-v13 50mg; hzVSF-v13 50 mg/dose + oral antiviral agent	Drug: Standard of care; The following medications listed are allowed to be administered during the course of the clinical study.; Tenofovir (including salt-free or salt-modifying drugs); Entecavir (including salt-free or salt-modifying drugs)
Experimental: hzVSF-v13 200mg; hzVSF-v13 200 mg/dose + oral antiviral agent	Drug: Standard of care; The following medications listed are allowed to be administered during the course of the clinical study.; Tenofovir (including salt-free or salt-modifying drugs); Entecavir (including salt-free or salt-modifying drugs)
Experimental: hzVSF-v13 800mg; hzVSF-v13 800 mg/dose + oral antiviral agent	Drug: Standard of care; The following medications listed are allowed to be administered during the course of the clinical study.; Tenofovir (including salt-free or salt-modifying drugs); Entecavir (including salt-free or salt-modifying drugs)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in HBsAg from the baseline at 24 weeks (log10 IU/mL)	Baseline statistics for the changes in HBsAg (log10 IU/mL) from the baseline at 24 weeks shall be presented for each group, and a two-sample t-test or the Wilcoxon rank-sum test shall be performed to test differences of each study group compared to the control group.	24 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of subjects with HBsAg loss or seroconversion compared to the baseline at 8, 12, 24 and 48 weeks	The number and percentage of subjects and 95% confidence interval for each treatment group and each evaluation time point shall be presented, and a chi-squared test or the Fisher's exact test shall be performed to test intergroup differences of each study group compared to the control group.	8, 12, 24, 48 weeks
Percentage of subjects with HBV DNA lower than the lower limit of quantification (LLOQ) compared to the baseline at 24 and 48 weeks	The number and percentage of subjects and 95% confidence interval for each treatment group and each evaluation time point shall be presented, and a chi-squared test or the Fisher's exact test shall be performed to test intergroup differences of each study group compared to the control group.	24, 48 weeks

Collaborators and Investigators

• Sponsor: ImmuneMed, Inc.
• Investigators: Principal Investigator: Joon Hyeok Lee, M.D. Ph.D., Samsung Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): January 11, 2022
• Primary Completion (Estimated): March 27, 2024
• Study Completion (Estimated): December 4, 2024

Study Registration Dates

• First Submitted: March 27, 2023
• First Submitted That Met QC Criteria: March 29, 2023
• First Posted (Actual): April 11, 2023

Study Record Updates

• Last Update Posted (Actual): June 15, 2023
• Last Update Submitted That Met QC Criteria: June 12, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Disease Attributes; Liver Diseases; Hepatitis, Viral, Human; Hepadnaviridae Infections; DNA Virus Infections; Chronic Disease; Hepatitis B; Hepatitis; Hepatitis B, Chronic; Hepatitis, Chronic
• Other Study ID Numbers: IM_hzVSF_v13-0003

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: It will be depending on internal discussion.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No