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

NCT ID: NCT05808335

Last Updated: 2023-06-15

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-01-11
• Study Completion Date: 2024-12-04

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.

Conditions

Chronic Hepatitis B

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Placebo to hzVSF-v13

Placebo to match hzVSF-v13 + oral antiviral agent

Group Type: PLACEBO_COMPARATOR

Standard of care

Intervention Type: 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)

hzVSF-v13 50mg

hzVSF-v13 50 mg/dose + oral antiviral agent

Group Type: EXPERIMENTAL

Standard of care

Intervention Type: 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)

hzVSF-v13 200mg

hzVSF-v13 200 mg/dose + oral antiviral agent

Group Type: EXPERIMENTAL

Standard of care

Intervention Type: 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)

hzVSF-v13 800mg

hzVSF-v13 800 mg/dose + oral antiviral agent

Group Type: EXPERIMENTAL

Standard of care

Intervention Type: 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)

Interventions

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)

Intervention Type: DRUG

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

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 64 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

ImmuneMed, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Joon Hyeok Lee, M.D. Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Samsung Medical Center

Locations

Chung-Ang University Hospital

Seoul, , South Korea

Site Status: RECRUITING

Samsung Medical Center

Seoul, , South Korea

Site Status: RECRUITING

Seoul National University Hospital

Seoul, , South Korea

Site Status: RECRUITING

Severance Hospital

Seoul, , South Korea

Site Status: RECRUITING

Countries

South Korea

Central Contacts

Sungman Park, Ph.D.

Role: CONTACT

smpark@immunemed.co.kr

82-33-258-6563 ext. 6563

Facility Contacts

Hyung Jun Kim, M.D. Ph.D.

Role: primary

Joon Hyeok Lee, M.D. Ph.D.

Role: primary

Yoon Jun Kim, M.D. Ph.D.

Role: primary

Do Young Kim, M.D. Ph.D.

Role: primary

Other Identifiers

IM_hzVSF_v13-0003

Identifier Type: -

Identifier Source: org_study_id