CompletedPhase 2

Study of VIR-2218 With or Without Pegylated Interferon Alpha-2a for Treatment of Chronic Hepatitis B Virus Infection

Australia, Hong Kong, Malaysia84 participantsStarted 2020-07-03

Plain-language summary

This is a phase 2 study in which subjects with chronic hepatitis B virus (HBV) infection will receive VIR-2218 alone or in combination with pegylated interferon alfa-2a and will be assessed for safety, tolerability, pharmacokinetics, and antiviral activity.

Who can participate

Age range18 Years – 65 Years

SexALL

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

Inclusion Criteria: * Male or female of ages 18 - 65 * Chronic HBV infection for \>/= 6 months Exclusion Criteria: * Any clinically significant chronic or acute medical condition that makes the volunteer unsuitable for participation * Significant fibrosis or cirrhosis * History or evidence of drug or alcohol abuse * History of intolerance to SC injection * History of chronic liver disease from any cause other than chronic HBV infection * History of hepatic decompensation * Any prior receipt of an interferon product

What they're measuring

Number of Subjects With Adverse Events as Assessed by CTCAE v5.0

Timeframe: Up to 148 Weeks

Number of Subjects With Abnormalities in Vital Signs, Electrocardiogram (ECG), and Clinically Significant Laboratory Findings

Timeframe: Up to 148 Weeks

Trial details

NCT IDNCT04412863

SponsorVir Biotechnology, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-03-25

Results submitted2025-03-25

View on ClinicalTrials.gov More Chronic Hepatitis B trials