CompletedPhase 2

Study of VIR-2218, VIR-3434, and/or PEG-IFNα in Subjects With Chronic Hepatitis B Virus Infection

United States244 participantsStarted 2021-07-11

Plain-language summary

This is a phase 2 study in which participants with chronic hepatitis B virus (HBV) infection will receive VIR-2218, VIR-3434 and/or PEG-IFNα and be assessed for safety, tolerability, and efficacy

Who can participate

Age range18 Years – 65 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Male or female ages 18 - \<66 years * Chronic HBV infection for \>/= 6 months * On NRTI therapy for \>/= 2 months at the time of screening Exclusion Criteria: * Any clinically significant chronic or acute medical condition that makes the participant unsuitable for participation * Significant fibrosis or cirrhosis * History or evidence of drug or alcohol abuse * History of chronic liver disease from any cause other than chronic HBV infection * History of hepatic decompensation * History of anaphylaxis * History of allergic reactions, hypersensitivity, or intolerance to monoclonal antibodies, antibody fragments, or any excipients of VIR-3434 * History of immune complex disease * History of known contraindication to any interferon product

What they're measuring

Proportion of participants with treatment-emergent adverse events (TEAEs)

Timeframe: Up to 72 weeks

Proportion of participants with serious adverse events (SAEs)

Timeframe: Up to 72 weeks

Proportion of participants with hepatitis B surface antigen (HBsAg) loss (defined as undetectable HBsAg) at end of treatment

Timeframe: Up to 48 weeks

Proportion of participants with HBsAg loss (defined as undetectable HBsAg) at 24 weeks post-end of treatment

Timeframe: Up to 72 weeks

Trial details

NCT IDNCT04856085

SponsorVir Biotechnology, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-03-16

View on ClinicalTrials.gov More Hepatitis B, Chronic trials

Who can participate

Age range18 Years – 65 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Proportion of participants with treatment-emergent adverse events (TEAEs)

Timeframe: Up to 72 weeks

Proportion of participants with serious adverse events (SAEs)

Timeframe: Up to 72 weeks

Proportion of participants with hepatitis B surface antigen (HBsAg) loss (defined as undetectable HBsAg) at end of treatment

Timeframe: Up to 48 weeks

Proportion of participants with HBsAg loss (defined as undetectable HBsAg) at 24 weeks post-end of treatment

Timeframe: Up to 72 weeks