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New treatment option for Hepatitis B, Chronic
Official title Vaccinal Effect of HBsAg Monoclonal Ab VIR-3434 in Chronic Hepatitis B Infection [VISION]
ClinicalTrials.gov ID: NCT06216470
What this study is testing
What is VIR-3434?
VIR-3434 is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for hepatitis b, chronic.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65
You may be able to join if
- 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
You likely can't join if
- History of cirrhosis as evidenced by prior Liver Elastography (Fibroscan) \> 12 kilopascals (kPa), liver biopsy (F4 by METAVIR) or clinical evidence...
- 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
See the full eligibility criteria
- 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
- Female people 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...
- Male people 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...
- Able and willing to sign informed consent
- 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
- 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...
- 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...
- 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...
- 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...
- Unable to provide informed consent
The study team makes the final eligibility decision.
Where it's taking place
- Toronto, Ontario, Canada
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Toronto, Ontario, Canada. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.