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

A Phase 1/2 Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Antiviral Activity of VIR-2218 Alone or in Combination With Pegylated Interferon Alpha-2a

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04412863

Enrollment

Registered

2020-06-02

Start date

2020-07-03

Completion date

2024-03-25

Last updated

2024-09-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Hepatitis B

Keywords

Hepatitis B Virus, Chronic Hepatitis B, HBV, Hepatitis

Brief 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.

Interventions

DRUGVIR-2218

VIR-2218 given by subcutaneous injection

DRUGpegylated interferon-alfa 2a

pegylated interferon-alfa 2a given by subcutaneous injection

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Number of subjects with Adverse Events as assessed by CTCAE v5.0	Up to 148 Weeks
Number of subjects with abnormalities in vital signs, electrocardiogram (ECG), and clinically significant laboratory findings	Up to 148 Weeks

Secondary

Measure	Time frame
Number of subjects with sustained serum HBsAg loss (undetectable HBsAg) for greater than 6 months	Up to 144 Weeks
Mean maximum reduction of serum HBsAg at any timepoint	Up to 144 Weeks
For HBeAg-positive subjects: number of subjects with HBeAg loss (undetectable HBeAg) and/or anti-HBe seroconversion at any timepoint	Up to 96 weeks
Number of subjects with anti-HBs seroconversion at any timepoint	Up to 144 Weeks
Number of subjects with serum HBsAg loss (undetectable HBsAg) at any timepoint	Up to 144 Weeks

Countries

Australia, Hong Kong, Malaysia, New Zealand, South Korea, Thailand

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026