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

NCT05808335 | Unknown Phase 2

• 1 other identifier: IM_hzVSF_v13-0003
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 4

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.

Conditions

Chronic Hepatitis B

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Percentage of subjects with HBsAg loss or seroconversion compared to the baseline at 8, 12, 24 and 48 weeks

  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

  24, 48 weeks

Study Arms (4)

Placebo to hzVSF-v13

PLACEBO COMPARATOR

Placebo to match hzVSF-v13 + oral antiviral agent

Drug: Standard of care

hzVSF-v13 50mg

EXPERIMENTAL

hzVSF-v13 50 mg/dose + oral antiviral agent

Drug: Standard of care

hzVSF-v13 200mg

EXPERIMENTAL

hzVSF-v13 200 mg/dose + oral antiviral agent

Drug: Standard of care

hzVSF-v13 800mg

EXPERIMENTAL

hzVSF-v13 800 mg/dose + oral antiviral agent

Drug: Standard of care

Interventions

Standard of care DRUG

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)

Placebo to hzVSF-v13; hzVSF-v13 200mg; hzVSF-v13 50mg; hzVSF-v13 800mg

Eligibility Criteria

• Age: 19 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• ImmuneMed, Inc.: lead

Study Sites (4)

Chung-Ang University Hospital

Seoul, South Korea

RECRUITING

Samsung Medical Center

Seoul, South Korea

RECRUITING

Seoul National University Hospital

Seoul, South Korea

RECRUITING

Severance Hospital

Seoul, South Korea

RECRUITING

MeSH Terms

Conditions

Hepatitis B, Chronic

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Hepatitis B; Blood-Borne Infections; Communicable Diseases; Infections; Hepadnaviridae Infections; DNA Virus Infections; Virus Diseases; Hepatitis, Viral, Human; Hepatitis, Chronic; Hepatitis; Liver Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Joon Hyeok Lee, M.D. Ph.D.

  Samsung Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sungman Park, Ph.D.

CONTACT

82-33-258-6563; smpark@immunemed.co.kr

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 27, 2023
• First Posted: April 11, 2023
• Study Start: January 11, 2022
• Primary Completion: March 27, 2024
• Study Completion: December 4, 2024
• Last Updated: June 15, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

KR (4)