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

Primary Purpose

Chronic Hepatitis B

Status
Recruiting
Phase
Phase 2
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Standard of care
Sponsored by
ImmuneMed, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Hepatitis B

Eligibility Criteria

19 Years - 64 Years (Adult)All SexesDoes not accept healthy volunteers

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

Arm Type

Placebo Comparator

Experimental

Experimental

Experimental

Arm Label

Placebo to hzVSF-v13

hzVSF-v13 50mg

hzVSF-v13 200mg

hzVSF-v13 800mg

Arm Description

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.

Full Information

First Posted
March 27, 2023
Last Updated
June 12, 2023
Sponsor
ImmuneMed, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT05808335
Brief Title
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

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 11, 2022 (Actual)
Primary Completion Date
March 27, 2024 (Anticipated)
Study Completion Date
December 4, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
ImmuneMed, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Hepatitis B

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
32 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Placebo to hzVSF-v13
Arm Type
Placebo Comparator
Arm Description
Placebo to match hzVSF-v13 + oral antiviral agent
Arm Title
hzVSF-v13 50mg
Arm Type
Experimental
Arm Description
hzVSF-v13 50 mg/dose + oral antiviral agent
Arm Title
hzVSF-v13 200mg
Arm Type
Experimental
Arm Description
hzVSF-v13 200 mg/dose + oral antiviral agent
Arm Title
hzVSF-v13 800mg
Arm Type
Experimental
Arm Description
hzVSF-v13 800 mg/dose + oral antiviral agent
Intervention Type
Drug
Intervention Name(s)
Standard of care
Intervention Description
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)
Primary Outcome Measure Information:
Title
Change in HBsAg from the baseline at 24 weeks (log10 IU/mL)
Description
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.
Time Frame
24 weeks
Secondary Outcome Measure Information:
Title
Percentage of subjects with HBsAg loss or seroconversion compared to the baseline at 8, 12, 24 and 48 weeks
Description
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.
Time Frame
8, 12, 24, 48 weeks
Title
Percentage of subjects with HBV DNA lower than the lower limit of quantification (LLOQ) compared to the baseline at 24 and 48 weeks
Description
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.
Time Frame
24, 48 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sungman Park, Ph.D.
Phone
82-33-258-6563
Ext
6563
Email
smpark@immunemed.co.kr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joon Hyeok Lee, M.D. Ph.D.
Organizational Affiliation
Samsung Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chung-Ang University Hospital
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hyung Jun Kim, M.D. Ph.D.
Facility Name
Samsung Medical Center
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Joon Hyeok Lee, M.D. Ph.D.
Facility Name
Seoul National University Hospital
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yoon Jun Kim, M.D. Ph.D.
Facility Name
Severance Hospital
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Do Young Kim, M.D. Ph.D.

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
It will be depending on internal discussion.

Learn more about this trial

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

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