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Vaccinal Effect of HBsAg Monoclonal Ab VIR-3434 in Chronic Hepatitis B Infection [VISION]

ConditionHepatitis B, Chronic
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-65
SponsorUniversity Health Network, Toronto

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

  • VIR-3434

    Drug

    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).

Treatment groups

15 Participants
are divided into 1 treatment group
Group A: VIR-3434Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Change in log Quantitative HBsAg

Time frame
from baseline through study completion, an average of 2 year

Secondary outcomes

1

Absolute and change of Hepatitis B Virus (HBV) RNA

Time frame
from baseline through study completion, an average of 2 year
2

Absolute and change of HBV core-related Ag

Time frame
from baseline through study completion, an average of 2 year
3

Proportion of subjects with HBsAg loss

Time frame
from baseline through study completion, an average of 2 year
4

HBeAg seroconversion

Proportion of subject with HBeAg seroconversion

Time frame
from baseline through study completion, an average of 2 year

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University Health Network, Toronto

Lead sponsor

Source ClinicalTrials.gov
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