Hepatitis B, ChronicPhase 2NCT06216470
Vaccinal Effect of HBsAg Monoclonal Ab VIR-3434 in Chronic Hepatitis B Infection [VISION]
A Phase 2 study testing VIR-3434 in people with Hepatitis B, Chronic, run by University Health Network, Toronto at 1 site in Canada.
Trial summary
This is a Phase II Investigator-Initiated Study to understand the vaccinal effect of HBsAg monoclonal Ab VIR-3434 in chronic hepatitis B infection. The purpose of this study is to test VIR-3434, an experimental drug that specifically targets the HBsAg of hepatitis B virus, to clear it from the body. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Hepatitis B, Chronic
- What is being tested?
- VIR-3434
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteCanada
- Study dates
- 13 Mar 2024to Dec 2029
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 to ≤65 years
- Chronic HBV infection with evidence of HBsAg-positivity x > 6 months
- Quantitative HBsAg 300 - 10,000 IU/mL
- On stable nucleos(t)ide therapy >1 year
- HBV DNA < 60 IU/mL on 2 occasions at least 12 weeks apart
- ALT ≤ 45 U/L on 2 occasions at least 12 weeks apart
Show all 9Show fewer
- Female subjects must have a negative pregnancy test or confirmation of postmenopausal status. Women of child-bearing potential (WOCBP) must have a negative pregnancy test at screening and on Day 1, cannot be breast feeding, and must be willing to use highly effective methods of contraception 14 days before study drug administration through the study participation. Female subjects must also agree to refrain from egg donation and in vitro fertilization from the time of study drug administration through the study participation.
- Male subjects with female partners of child-bearing potential must agree to meet 1 of the following contraception requirements from the time of study drug administration through the study participation: documentation of vasectomy or azoospermia, or male condom use plus partner use of 1 of the contraceptive options listed for contraception for WOCBP. Male subjects must also agree to not donate sperm from the time of study drug administration through the study participation.
- Able and willing to sign informed consent
Who cannot join
- History of cirrhosis as evidenced by prior Liver Elastography (Fibroscan) > 12 kilopascals (kPa), liver biopsy (F4 by METAVIR) or clinical evidence of decompensation (ascites, hepatic encephalopathy)
- History of or current hepatocellular carcinoma
- Hepatitis C Virus (HCV) RNA or anti-Hepatitis D Virus (HDV) positive
- HIV co-infection
- Pregnancy or lactation
- Alanine Aminotransferase (ALT) > 45 U/L
Show all 23Show fewer
- History of chronic liver disease other than HBV aside from fatty liver documented only on US
- Use of peginterferon therapy for HBV infection within past 12 months
- Use of chronic immunosuppressive medications at a dose equivalent to 10 mg daily of prednisone or greater within past 6 months
- Other significant medical illness that might interfere with this study: significant pulmonary dysfunction in previous 6 months, malignancy other than non-melanoma skin cancer in previous 5 years, immunodeficiency syndrome
- Subject has received any investigational drug (including any investigational vaccines) within 90 days or 5 half-lives (whatever is longer) before screening for this study or is currently enrolled in an investigational study
- Subject has any condition for which, in the opinion of the investigator, participation would not be in the best interest of the subject (eg, compromise the well-being) or that could prevent, limit, or confound the protocol-specified assessments, such as liver FNAs
- Platelet count < 120,000,000,000/L
- The International Normalised Ratio (INR) > 1.3
- Bilirubin > 40 µmol/L
- Hemoglobin < 110 g/dL for women or 120 g/dL for men
- estimated Glomerular Filtration Rate (eGFR) < 45 cc/min
- Alpha Fetoprotein (AFP) > 50 ng/mL
- Prior liver or other solid organ transplantation
- Patients on anticoagulation therapy or with any bleeding diathesis
- Patients with hemoglobinopathy (thalassemia, sickle cell disease etc)
- Other significant liver disease: alcoholic liver disease, autoimmune hepatitis, hemochromatosis, primary biliary cholangitis, primary sclerosing cholangitis, Wilson Disease or alpha-1 antitrypsin deficiency - as documented in clinical history
- Unable to provide informed consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
University Health Network
Toronto, Ontario, M5G2C4
Jordan Feld, 416-340-4584, jordan.feld@uhn.ca
Jiayun Chen, 416-340-4800 ext. 6854, jiayun.chen@uhn.ca
About this study
Official title: Phase II Investigator-Initiated Study to Understand the Vaccinal Effect of HBsAg Monoclonal Ab VIR-3434 in Chronic Hepatitis B Infection
This is a Phase II Investigator-Initiated Study to understand the vaccinal effect of HBsAg monoclonal Ab VIR-3434 in chronic hepatitis B infection.
The purpose of this study is to test VIR-3434, an experimental drug that specifically targets the HBsAg of hepatitis B virus, to clear it from the body.
This is an open label study and there is no placebo used in this study. All participants will receive the VIR-3434 for 48 weeks and then follow up in the study for 48 weeks. A total duration of approximately 104 weeks including screening period for the entire study.
Read the detailed description
The objective of this study is to evaluate the vaccinal effect of VIR-3434 in chronic HBeAg-negative hepatitis B (CHB) patients suppressed on nucleos(t)ide analogue therapy. Total 15 patients will be enrolled at single site.
The participants will receive VIR-3434 300 mg subcutaneous injection every 4 weeks x 48 weeks and then follow up for 48 weeks. Total three Fine-needle aspiration (FNA) procedure will be performed during the study: before treatment, 3 days after the first injection and 3 days after the week24 injection.
- Conditions
- Hepatitis B, Chronic
- Being tested
- VIR-3434
- 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.
VIR-3434Drug
VIR-3434 is a human monoclonal antibody that binds the antigenic loop present in all forms of the surface envelope protein (small, middle, and large HBsAg).
| Study group | Role | What they receive |
|---|---|---|
| VIR-3434 | Experimental | VIR-3434 300 mg subcutaneous injection every 4 weeks*48 weeks Receives: Drug: VIR-3434 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in log Quantitative HBsAg
Measured: from baseline through study completion, an average of 2 year
Secondary outcomes (6)
Absolute and change of Hepatitis B Virus (HBV) RNA
Measured: from baseline through study completion, an average of 2 year
Absolute and change of HBV core-related Ag
Measured: from baseline through study completion, an average of 2 year
Proportion of subjects with HBsAg loss
Measured: from baseline through study completion, an average of 2 year
HBeAg seroconversion
Proportion of subject with HBeAg seroconversion
Measured: from baseline through study completion, an average of 2 year
Frequency of Adverse Events (AEs) and Serious Adverse Events (SAEs) with study treatment
Frequency of AEs and SAEs with VIR-3434 administration in combination with NA therapy for CHB
Measured: from baseline through study completion, an average of 2 year
Frequency of AEs and SAEs due to hepatic FNA
Measured: from baseline through study completion, an average of 2 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2024
- Study start13 Mar 2024
- Primary completionDec 2029 (estimated)
- Study completionDec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatitis B, ChronicStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jordan Feld, MD, Principal investigator, University Health Network, Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06216470
- Sponsor's protocol ID
- 23-5492
- Status last verified
- May 2025
- First submitted
- 8 Jan 2024
- Last updated
- 29 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Investigator-Initiated Study to Understand the Vaccinal Effect of HBsAg Monoclonal Ab VIR-3434 in Chronic Hepatitis B Infection
- ClinicalTrials.gov ID
- NCT06216470
- Acronym / sponsor ID
- 23-5492
- Conditions
- Hepatitis B, Chronic
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Study start
- 13 Mar 2024 (actual)
- Primary completion
- Dec 2029 (estimated)
- Study completion
- Dec 2029 (estimated)
- First posted
- 22 Jan 2024 (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 Phase II Investigator-Initiated Study to understand the vaccinal effect of HBsAg monoclonal Ab VIR-3434 in chronic hepatitis B infection.
The purpose of this study is to test VIR-3434, an experimental drug that specifically targets the HBsAg of hepatitis B virus, to clear it from the body.
This is an open label study and there is no placebo used in this study. All participants will receive the VIR-3434 for 48 weeks and then follow up in the study for 48 weeks. A total duration of approximately 104 weeks including screening period for the entire study.
Detailed description
The objective of this study is to evaluate the vaccinal effect of VIR-3434 in chronic HBeAg-negative hepatitis B (CHB) patients suppressed on nucleos(t)ide analogue therapy. Total 15 patients will be enrolled at single site.
The participants will receive VIR-3434 300 mg subcutaneous injection every 4 weeks x 48 weeks and then follow up for 48 weeks. Total three Fine-needle aspiration (FNA) procedure will be performed during the study: before treatment, 3 days after the first injection and 3 days after the week24 injection.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| VIR-3434 | Experimental | Drug: VIR-3434VIR-3434 300 mg subcutaneous injection every 4 weeks*48 weeks |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Age ≥ 18 to ≤65 years
- Chronic HBV infection with evidence of HBsAg-positivity x > 6 months
- Quantitative HBsAg 300 - 10,000 IU/mL
- On stable nucleos(t)ide therapy >1 year
- HBV DNA < 60 IU/mL on 2 occasions at least 12 weeks apart
Key exclusion criteria (23 listed)
- History of cirrhosis as evidenced by prior Liver Elastography (Fibroscan) > 12 kilopascals (kPa), liver biopsy (F4 by METAVIR) or clinical evidence of decompensation (ascites, hepatic encephalopathy)
- History of or current hepatocellular carcinoma
- Hepatitis C Virus (HCV) RNA or anti-Hepatitis D Virus (HDV) positive
- HIV co-infection
- Pregnancy or lactation
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 |
|---|---|---|
| VIR-3434VIR-3434 is a human monoclonal antibody that binds the antigenic loop present in all forms of the surface envelope protein (small, middle, and large HBsAg). | Drug | VIR-3434 |
Primary outcome
Change in log Quantitative HBsAg
Time frame: from baseline through study completion, an average of 2 year
6 secondary outcomes
Absolute and change of Hepatitis B Virus (HBV) RNA
Time frame: from baseline through study completion, an average of 2 year
Absolute and change of HBV core-related Ag
Time frame: from baseline through study completion, an average of 2 year
Proportion of subjects with HBsAg loss
Time frame: from baseline through study completion, an average of 2 year
HBeAg seroconversion
Time frame: from baseline through study completion, an average of 2 year
Frequency of Adverse Events (AEs) and Serious Adverse Events (SAEs) with study treatment
Time frame: from baseline through study completion, an average of 2 year
Frequency of AEs and SAEs due to hepatic FNA
Time frame: from baseline through study completion, an average of 2 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2025.
- Individual participant dataSharing planned: No
Related trials for Hepatitis B, Chronic
Active, not recruitingPhase 2
A Study of Sequential Therapy With Daplusiran/Tomligisiran (DAP/TOM) Followed by Bepirovirsen in Participants Living With Chronic Hepatitis B (CHB)
Chronic Hepatitis B Virus Infection, Hepatitis B
RecruitingObservational study
Evaluation of Patients With Liver Disease
Hepatitis D, Hepatitis C
Active, not recruitingPhase 2
Study of Bepirovirsen in Participants Living With Human Immunodeficiency Virus and Chronic Hepatitis B Virus Infection (B-Focus)
Hepatitis B
Active, not recruitingPhase 2
Long-term Follow-up Study to Evaluate Durability of Treatment Response in Previous Bepirovirsen Study Participants (B-Sure)
Hepatitis B
Enrolling by invitationPhase 1
A Phase I Clinical Trial of CPU-YL01 Injection in Patients With Chronic Hepatitis B.
Chronic Hepatitis B
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.
Jordan Feld, MD principal investigator
University Health Network, Toronto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing VIR-3434 in people with Hepatitis B, Chronic, run by University Health Network, Toronto at 1 site in Canada.
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 9 inclusion and 23 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: looking for participants now, as of the sponsor's last update on 29 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. 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. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jordan Feld, MD (416-340-4584, jordan.feld@uhn.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in log Quantitative HBsAg (time frame: from baseline through study completion, an average of 2 year). 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 29 May 2025.