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

Chronic Hepatitis B Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05808335
• Other study ID #: IM_hzVSF_v13-0003
• Status: Recruiting
• Phase: Phase 2
• Start date: January 11, 2022
• Est. completion date: December 4, 2024

Study information

• Verified date: June 2023
• Source: ImmuneMed, Inc.
• Contact: Sungman Park, Ph.D.
• Phone: 82-33-258-6563
• Email: smpark[@]immunemed.co.kr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 32
• Est. completion date: December 4, 2024
• Est. primary completion date: March 27, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 64 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Hepatitis B
• Hepatitis
• Hepatitis B
• Hepatitis B, Chronic
• Hepatitis, Chronic

Intervention

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)

Locations

Country	Name	City	State
Korea, Republic of	Chung-Ang University Hospital	Seoul
Korea, Republic of	Samsung Medical Center	Seoul
Korea, Republic of	Seoul National University Hospital	Seoul
Korea, Republic of	Severance Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
ImmuneMed, Inc.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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