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

NCT06216470 | Recruiting Phase 2 FDA Drug

• 1 other identifier: 23-5492
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief 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. 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

Hepatitis B, Chronic

Outcome Measures

Primary Outcomes (1)

• Change in log Quantitative HBsAg

  from baseline through study completion, an average of 2 year

Secondary Outcomes (6)

• Absolute and change of Hepatitis B Virus (HBV) RNA

  from baseline through study completion, an average of 2 year

• Absolute and change of HBV core-related Ag

  from baseline through study completion, an average of 2 year

• Proportion of subjects with HBsAg loss

  from baseline through study completion, an average of 2 year

• HBeAg seroconversion

  from baseline through study completion, an average of 2 year

• Frequency of Adverse Events (AEs) and Serious Adverse Events (SAEs) with study treatment

  from baseline through study completion, an average of 2 year

Study Arms (1)

VIR-3434

EXPERIMENTAL

VIR-3434 300 mg subcutaneous injection every 4 weeks\*48 weeks

Drug: VIR-3434

Interventions

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).

VIR-3434

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify 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
• ALT ≤ 45 U/L on 2 occasions at least 12 weeks apart
• 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

You may not qualify if:

• 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 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

Sponsors & Collaborators

• University Health Network, Toronto: lead

Study Sites (1)

University Health Network

Toronto, Ontario, M5G2C4, Canada

RECRUITING

MeSH Terms

Conditions

Hepatitis B, Chronic

Condition Hierarchy (Ancestors)

Hepatitis B; Blood-Borne Infections; Communicable Diseases; Infections; Hepadnaviridae Infections; DNA Virus Infections; Virus Diseases; Hepatitis, Viral, Human; Hepatitis, Chronic; Hepatitis; Liver Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Jordan Feld, MD

  University Health Network, Toronto

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jordan Feld, MD

CONTACT

416-340-4584; jordan.feld@uhn.ca

Jiayun Chen

CONTACT

416-340-4800; jiayun.chen@uhn.ca

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 8, 2024
• First Posted: January 22, 2024
• Study Start: March 13, 2024
• Primary Completion (Estimated): December 1, 2029
• Study Completion (Estimated): December 1, 2029
• Last Updated: May 29, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)