Actively Recruiting
Vaccinal Effect of HBsAg Monoclonal Ab VIR-3434 in Chronic Hepatitis B Infection [VISION]
Led by University Health Network, Toronto · Updated on 2025-05-29
15
Participants Needed
1
Research Sites
298 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Vaccinal Effect of HBsAg Monoclonal Ab VIR-3434 in Chronic Hepatitis B Infection [VISION]
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 to 65 years
- Chronic hepatitis B infection with HBsAg positivity for more than 6 months
- Quantitative HBsAg levels between 300 and 10,000 IU/mL
- On stable nucleos(t)ide analogue therapy for more than 1 year
- HBV DNA less than 60 IU/mL on two occasions at least 12 weeks apart
- ALT level less than or equal to 45 U/L on two occasions at least 12 weeks apart
- Female participants must have a negative pregnancy test or be postmenopausal; women of child-bearing potential must have negative pregnancy tests at screening and on Day 1, not be breastfeeding, and agree to use effective contraception during the study
- Male participants with female partners of child-bearing potential must use contraception or meet specified conditions and agree not to donate sperm during the study
- Able and willing to provide informed consent
You will not qualify if you...
- History of liver cirrhosis, liver biopsy F4 by METAVIR, or clinical signs of liver decompensation
- History of or current hepatocellular carcinoma
- Positive for hepatitis C virus RNA or anti-hepatitis D virus antibodies
- Co-infection with HIV
- Pregnancy or breastfeeding
- ALT levels above 45 U/L
- History of chronic liver diseases other than HBV except fatty liver seen on ultrasound
- Use of peginterferon therapy for HBV within the past 12 months
- Use of immunosuppressive medications equivalent to prednisone 10 mg daily or higher within past 6 months
- Other significant medical illnesses that could interfere with the study, such as recent pulmonary dysfunction, recent malignancy (except non-melanoma skin cancer), or immunodeficiency
- Participation in another investigational drug study within 90 days or 5 half-lives
- Conditions preventing participation or protocol assessments, including liver fine-needle aspirations
- Platelet count below 120,000,000,000/L
- International Normalised Ratio above 1.3
- Bilirubin above 40 micromol/L
- Hemoglobin below 110 g/dL for women or 120 g/dL for men
- Estimated glomerular filtration rate less than 45 cc/min
- Alpha fetoprotein above 50 ng/mL
- Prior liver or other solid organ transplant
- Use of anticoagulation therapy or bleeding disorders
- Hemoglobinopathies such as thalassemia or sickle cell disease
- Other significant liver diseases including alcoholic liver disease, autoimmune hepatitis, hemochromatosis, primary biliary cholangitis, primary sclerosing cholangitis, Wilson disease, or alpha-1 antitrypsin deficiency
- Unable to provide informed consent
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
University Health Network
Toronto, Ontario, Canada, M5G2C4
Actively Recruiting
Research Team
J
Jordan Feld, MD
CONTACT
J
Jiayun Chen
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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