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

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

84

Phase

  • 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

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
Intervention / Treatment
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

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

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

Vir Biotechnology, Inc.

Collaborators

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)

July 3, 2020

Primary Completion (Actual)

March 25, 2024

Study Completion (Actual)

March 25, 2024

Study Registration Dates

First Submitted

May 29, 2020

First Submitted That Met QC Criteria

May 29, 2020

First Posted (Actual)

June 2, 2020

Study Record Updates

Last Update Posted (Actual)

April 16, 2026

Last Update Submitted That Met QC Criteria

March 27, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID 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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