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

March 27, 2026 updated by: Vir Biotechnology, Inc.

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
84

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • Queensland
      • Birtinya, Queensland, Australia, 4575
        • Investigative Site
    • Victoria
      • Fitzroy, Victoria, Australia, 3168
        • Investigative Site
  • Hong Kong
      • Hong Kong, Hong Kong
        • Investigative Site
  • Malaysia
      • Batu Caves, Malaysia, 68100
        • Investigative Site
      • Kajang, Malaysia, 43000
        • Investigative Site
      • Kuala Lumpur, Malaysia, 59100
        • Investigative Site
      • Kuantan, Malaysia, 25100
        • Investigative Site
  • New Zealand
      • Auckland, New Zealand, 1010
        • Investigative Site
      • Auckland, New Zealand, 2025
        • Investigative Site
  • South Korea
      • Busan, South Korea, 49241
        • Investigative Site
      • Chuncheon, South Korea, 24253
        • Investigative Site
      • Daegu, South Korea, 41944
        • Investigative Site
      • Seoul, South Korea, 03080
        • Investigative Site
      • Seoul, South Korea, 05505
        • Investigative Site
      • Yangsan, South Korea, 50612
        • Investigative Site
  • Thailand
      • Bangkok, Thailand, 10330
        • Investigative Site
      • Bangkok, Thailand, 10400
        • Investigative Site
      • Bangkok, Thailand, 10700
        • Investigative Site
      • Chiang Mai, Thailand, 50200
        • Investigative Site
      • Hat Yai, Thailand, 90110
        • Investigative Site
      • Khlong Luang, Thailand, 12120
        • Investigative Site
      • Khon Kaen, Thailand, 40002
        • Investigative Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Cohort 1d
VIR-2218 given by subcutaneous injection
Drug: VIR-2218
VIR-2218 given by subcutaneous injection
Other Names:
  • Elebsiran
Experimental: Cohort 2d
VIR-2218 and pegylated interferon-alfa 2a given by subcutaneous injection
Drug: VIR-2218
VIR-2218 given by subcutaneous injection
Other Names:
  • Elebsiran
Drug: pegylated interferon-alfa 2a
pegylated interferon-alfa 2a given by subcutaneous injection
Other Names:
  • pegylated interferon alpha-2a
  • PEG-IFNα
Experimental: Cohort 3d
VIR-2218 and pegylated interferon-alfa 2a given by subcutaneous injection
Drug: VIR-2218
VIR-2218 given by subcutaneous injection
Other Names:
  • Elebsiran
Drug: pegylated interferon-alfa 2a
pegylated interferon-alfa 2a given by subcutaneous injection
Other Names:
  • pegylated interferon alpha-2a
  • PEG-IFNα
Experimental: Cohort 1e
VIR-2218 given by subcutaneous injection
Drug: VIR-2218
VIR-2218 given by subcutaneous injection
Other Names:
  • Elebsiran
Experimental: Cohort 2e
VIR-2218 and pegylated interferon-alfa 2a given by subcutaneous injection
Drug: VIR-2218
VIR-2218 given by subcutaneous injection
Other Names:
  • Elebsiran
Drug: pegylated interferon-alfa 2a
pegylated interferon-alfa 2a given by subcutaneous injection
Other Names:
  • pegylated interferon alpha-2a
  • PEG-IFNα
Experimental: Cohort 3e
VIR-2218 and pegylated interferon-alfa 2a given by subcutaneous injection
Drug: VIR-2218
VIR-2218 given by subcutaneous injection
Other Names:
  • Elebsiran
Drug: pegylated interferon-alfa 2a
pegylated interferon-alfa 2a given by subcutaneous injection
Other Names:
  • pegylated interferon alpha-2a
  • PEG-IFNα
Experimental: Cohort 1f
VIR-2218 and pegylated interferon-alfa 2a given by subcutaneous injection
Drug: VIR-2218
VIR-2218 given by subcutaneous injection
Other Names:
  • Elebsiran
Drug: pegylated interferon-alfa 2a
pegylated interferon-alfa 2a given by subcutaneous injection
Other Names:
  • pegylated interferon alpha-2a
  • PEG-IFNα
Experimental: Cohort 2f
VIR-2218 and pegylated interferon-alfa 2a given by subcutaneous injection
Drug: VIR-2218
VIR-2218 given by subcutaneous injection
Other Names:
  • Elebsiran
Drug: pegylated interferon-alfa 2a
pegylated interferon-alfa 2a given by subcutaneous injection
Other Names:
  • pegylated interferon alpha-2a
  • PEG-IFNα
Experimental: Cohort 3f
VIR-2218 and pegylated interferon-alfa 2a given by subcutaneous injection
Drug: VIR-2218
VIR-2218 given by subcutaneous injection
Other Names:
  • Elebsiran
Drug: pegylated interferon-alfa 2a
pegylated interferon-alfa 2a given by subcutaneous injection
Other Names:
  • pegylated interferon alpha-2a
  • PEG-IFNα

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Number of Subjects With Adverse Events as Assessed by CTCAE v5.0
Time Frame: Up to 148 Weeks
Up to 148 Weeks
Number of Subjects With Abnormalities in Vital Signs, Electrocardiogram (ECG), and Clinically Significant Laboratory Findings
Time Frame: Up to 148 Weeks
Up to 148 Weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Mean Maximum Reduction of Serum HBsAg at Any Timepoint
Time Frame: Up to 148 Weeks
Up to 148 Weeks
Proportion of Subjects With Serum HBsAg Loss (Undetectable HBsAg) at Any Timepoint
Time Frame: Up to 148 Weeks
Up to 148 Weeks
Proportion of Subjects With Sustained Serum HBsAg Loss (Undetectable HBsAg) for Greater Than 6 Months
Time Frame: Up to 148 Weeks
Up to 148 Weeks
Proportion of Subjects With Anti-HBs Seroconversion at Any Timepoint
Time Frame: Up to 148 Weeks
Anti-HBs seroconversion is defined as Anti-HBs quantitative value changed from baseline <LLOQ (5 mIU/mL) to post-baseline>=LLOQ.
Up to 148 Weeks
For HBeAg-positive Patients: Proportion of Subjects With HBeAg Loss (Undetectable HBeAg) and/or Anti-HBe Seroconversion at Any Timepoint
Time Frame: Up to 148 weeks
Up to 148 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Vir Biotechnology, Inc.

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Alnylam Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 3, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 25, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 25, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 29, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 29, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 2, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 16, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 27, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • VIR-2218-1001-PEG-IFNα

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Locations

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