Chronic Hepatitis BPhase 2NCT05808335
A Study to Assess the Efficacy and Safety of Burfiralimab(hzVSF-v13) and OAD (Oral Antiviral Drug)
A Phase 2 study of Chronic Hepatitis B, run by ImmuneMed, Inc. at 4 sites in South Korea.
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… Read more about this study
- Who is it for?
- Ages 19 to 64 years
- Conditions the study is for
- Chronic Hepatitis B
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 4 sitesSouth Korea
- Study dates
- 11 Jan 2022to 4 Dec 2024
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
4 sites in 1 country.
South Korea4 sites, 4 recruiting
- Recruiting
Chung-Ang University Hospital
Seoul
Hyung Jun Kim, M.D. Ph.D.
- Recruiting
Samsung Medical Center
Seoul
Joon Hyeok Lee, M.D. Ph.D.
- Recruiting
Seoul National University Hospital
Seoul
Yoon Jun Kim, M.D. Ph.D.
- Recruiting
Severance Hospital
Seoul
Do Young Kim, M.D. Ph.D.
About this study
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
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.
Read the 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
- Being tested
- Standard of care
- Medical subject headings
- Hepatitis B, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard of careDrug
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)
| Study group | Role | What they receive |
|---|---|---|
| Placebo to hzVSF-v13 | Placebo comparator | Placebo to match hzVSF-v13 + oral antiviral agent Receives: Drug: Standard of care |
| hzVSF-v13 50mg | Experimental | hzVSF-v13 50 mg/dose + oral antiviral agent Receives: Drug: Standard of care |
| hzVSF-v13 200mg | Experimental | hzVSF-v13 200 mg/dose + oral antiviral agent Receives: Drug: Standard of care |
| hzVSF-v13 800mg | Experimental | hzVSF-v13 800 mg/dose + oral antiviral agent Receives: Drug: Standard of care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 24 weeks
Secondary outcomes (2)
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.
Measured: 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.
Measured: 24, 48 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2023
- Study start11 Jan 2022
- Primary completion27 Mar 2024 (estimated)
- Study completion4 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Hepatitis BStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ImmuneMed, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Joon Hyeok Lee, M.D. Ph.D., Principal investigator, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05808335
- Sponsor's protocol ID
- IM_hzVSF_v13-0003
- Status last verified
- Jun 2023
- First submitted
- 27 Mar 2023
- Last updated
- 15 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: It will be depending on internal discussion.
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05808335
- Acronym / sponsor ID
- IM_hzVSF_v13-0003
- Conditions
- Chronic Hepatitis B
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- ImmuneMed, Inc.Industry (pharma, biotech, devices)
- Study start
- 11 Jan 2022 (actual)
- Primary completion
- 27 Mar 2024 (estimated)
- Study completion
- 4 Dec 2024 (estimated)
- First posted
- 11 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Placebo to hzVSF-v13 | Placebo comparator | Drug: Standard of carePlacebo to match hzVSF-v13 + oral antiviral agent |
| hzVSF-v13 50mg | Experimental | Drug: Standard of carehzVSF-v13 50 mg/dose + oral antiviral agent |
| hzVSF-v13 200mg | Experimental | Drug: Standard of carehzVSF-v13 200 mg/dose + oral antiviral agent |
| hzVSF-v13 800mg | Experimental | Drug: Standard of carehzVSF-v13 800 mg/dose + oral antiviral agent |
Who may qualify
- Ages
- 19 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard of careThe 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) | Drug | Placebo to hzVSF-v13, hzVSF-v13 200mg, hzVSF-v13 50mg, hzVSF-v13 800mg |
Primary outcome
Change in HBsAg from the baseline at 24 weeks (log10 IU/mL)
Time frame: 24 weeks
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.
2 secondary outcomes
Percentage of subjects with HBsAg loss or seroconversion compared to the baseline at 8, 12, 24 and 48 weeks
Time frame: 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
Time frame: 24, 48 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2023.
- Individual participant dataSharing planned: No. It will be depending on internal discussion.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joon Hyeok Lee, M.D. Ph.D. principal investigator
Samsung Medical Center
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study of Chronic Hepatitis B, run by ImmuneMed, Inc. at 4 sites in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sungman Park, Ph.D. (82-33-258-6563 ext. 6563, smpark@immunemed.co.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in HBsAg from the baseline at 24 weeks (log10 IU/mL) (time frame: 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2023.