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

April 21, 2026 updated by: Vir Biotechnology, Inc.

A Phase 2 Study to Evaluate the Safety, Tolerability, and Efficacy of Regimens Containing VIR-2218, VIR-3434, and/or PEG-IFNα in Subjects With Chronic Hepatitis B Virus Infection

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

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.

Detailed Description

Subjects may be enrolled into cohorts 1a, 2a, 3a, 4a, 5a, 6a, 1b, and 2b in a non-randomized manner. Subjects may be enrolled in cohorts 7a, 8a, 1c, and 2c and will be randomized.

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.
244

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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Canada
      • Toronto, Canada, 2C4
        • Investigative Site
      • Toronto, Canada, 3M1
        • Investigative Site
      • Vancouver, Canada, 2C7
        • Investigative Site
  • Germany
      • Frankfurt, Germany, 60590
        • Investigative Site
      • Hanover, Germany, 30625
        • Investigative Site
      • Mannheim, Germany, 68167
        • Investigative Site
  • Hong Kong
      • Hong Kong, Hong Kong
        • Investigative Site
    • Shatin
      • Hong Kong, Shatin, Hong Kong
        • Investigative Site
    • Tai Po District
      • Hong Kong, Tai Po District, Hong Kong
        • Investigative Site
  • Malaysia
      • Kuala Lumpur, Malaysia, 59100
        • Investigative Site
  • Moldova
      • Chisinau, Moldova, MD 2025
        • Investigative Site
  • New Zealand
      • Auckland, New Zealand, 1010
        • Investigative Site
      • Auckland, New Zealand, 2025
        • Investigative Site
      • Hamilton, New Zealand, 3204
        • Investigative Site
      • Tauranga, New Zealand, 3110
        • Investigative Site
      • Wellington, New Zealand, 6021
        • Investigative Site
  • Romania
      • Bucharest, Romania, 021105
        • Investigative Site
  • South Korea
      • Busan, South Korea, 49421
        • Investigative Site
      • Seoul, South Korea, 03080
        • Investigative Site
      • Seoul, South Korea, 05505
        • Investigative Site
      • Yangsan, South Korea, 50612
        • Investigative Site
  • Taiwan
      • Chiayi City, Taiwan, 60041
        • Investigative Site
      • Kaohsiung City, Taiwan, 80756
        • Investigative Site
      • Kaohsiung City, Taiwan, 83301
        • Investigative Site
      • Taichung, Taiwan, 40705
        • Investigative Site
      • Taipei, Taiwan, 100
        • Investigative Site
      • Taoyuan, Taiwan, 33305
        • Investigative Site
  • Ukraine
      • Kyiv, Ukraine, 01135
        • Investigative Site
  • United Kingdom
      • Birmingham, United Kingdom, B15 2TH
        • Investigative Site
      • London, United Kingdom, SE5 9RS
        • Investigative Site
      • London, United Kingdom, E11FR
        • Investigative Site
      • Manchester, United Kingdom, M8 5RB
        • Investigative Site
  • United States
    • California
      • San Francisco, California, United States, 94143
        • Investigative Site
    • Florida
      • Miami, Florida, United States, 33136
        • Investigative Site
      • Orlando, Florida, United States, 32803
        • Investigative Site
    • Maryland
      • Baltimore, Maryland, United States, 21218
        • Investigative Site
    • New Jersey
      • Hillsborough, New Jersey, United States, 08844
        • 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 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

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 1a (VIR-2218 + VIR-3434)
Participants will receive multiple lead-in doses of VIR-2218, then combination therapy with VIR-2218 + VIR-3434 for 20 weeks total
Drug: VIR-2218
VIR-2218 given by subcutaneous injection
Other Names:
  • Elebsiran
Drug: VIR-3434
VIR-3434 given by subcutaneous injection
Other Names:
  • Tobevibart
Experimental: Cohort 2a (VIR-2218 + VIR-3434)
Participants will receive multiple lead-in doses of VIR-2218, then combination therapy with VIR-2218 + VIR-3434 for 20 weeks total
Drug: VIR-2218
VIR-2218 given by subcutaneous injection
Other Names:
  • Elebsiran
Drug: VIR-3434
VIR-3434 given by subcutaneous injection
Other Names:
  • Tobevibart
Experimental: Cohort 3a (VIR-2218 + VIR-3434)
Participants will receive multiple doses of VIR-2218 + VIR-3434 for 4 weeks
Drug: VIR-2218
VIR-2218 given by subcutaneous injection
Other Names:
  • Elebsiran
Drug: VIR-3434
VIR-3434 given by subcutaneous injection
Other Names:
  • Tobevibart
Experimental: Cohort 4a (VIR-2218 + VIR-3434)
Participants will receive multiple doses of VIR-2218 + VIR-3434 for 4 weeks
Drug: VIR-2218
VIR-2218 given by subcutaneous injection
Other Names:
  • Elebsiran
Drug: VIR-3434
VIR-3434 given by subcutaneous injection
Other Names:
  • Tobevibart
Experimental: Cohort 5a (VIR-2218 + VIR-3434)
Participants will receive multiple doses of VIR-2218 + VIR-3434 for 11 weeks
Drug: VIR-2218
VIR-2218 given by subcutaneous injection
Other Names:
  • Elebsiran
Drug: VIR-3434
VIR-3434 given by subcutaneous injection
Other Names:
  • Tobevibart
Experimental: Cohort 6a (VIR-2218 + VIR-3434)
Participants will receive multiple doses of VIR-2218 + VIR-3434 for 11 weeks
Drug: VIR-2218
VIR-2218 given by subcutaneous injection
Other Names:
  • Elebsiran
Drug: VIR-3434
VIR-3434 given by subcutaneous injection
Other Names:
  • Tobevibart
Experimental: Cohort 7a (VIR-2218 + VIR-3434)
Participants will receive multiple doses of VIR-2218 + VIR-3434 for 44 weeks
Drug: VIR-2218
VIR-2218 given by subcutaneous injection
Other Names:
  • Elebsiran
Drug: VIR-3434
VIR-3434 given by subcutaneous injection
Other Names:
  • Tobevibart
Experimental: Cohort 8a (VIR-2218 + VIR-3434)
Participants will receive multiple doses of VIR-2218 + VIR-3434 for 20 weeks
Drug: VIR-2218
VIR-2218 given by subcutaneous injection
Other Names:
  • Elebsiran
Drug: VIR-3434
VIR-3434 given by subcutaneous injection
Other Names:
  • Tobevibart
Experimental: Cohort 1b (VIR-3434)
Participants will receive multiple doses of VIR-3434 for 44 weeks
Drug: VIR-3434
VIR-3434 given by subcutaneous injection
Other Names:
  • Tobevibart
Experimental: Cohort 2b (VIR-3434)
Participants will receive multiple doses of VIR-3434 for 20 weeks
Drug: VIR-3434
VIR-3434 given by subcutaneous injection
Other Names:
  • Tobevibart
Experimental: Cohort 1c (VIR-2218 + VIR-3434 + PEG-IFNα)
Participants will receive multiple doses of VIR-2218 + VIR-3434 + PEG-IFNα for 24 weeks
Drug: VIR-2218
VIR-2218 given by subcutaneous injection
Other Names:
  • Elebsiran
Drug: VIR-3434
VIR-3434 given by subcutaneous injection
Other Names:
  • Tobevibart
Drug: PEG-IFNα
PEG-IFNα given by subcutaneous injection
Experimental: Cohort 2c (VIR-2218 + VIR-3434 + PEG-IFNα)
Participants will receive multiple doses of VIR-2218 + VIR-3434 + PEG-IFNα for 48 weeks
Drug: VIR-2218
VIR-2218 given by subcutaneous injection
Other Names:
  • Elebsiran
Drug: VIR-3434
VIR-3434 given by subcutaneous injection
Other Names:
  • Tobevibart
Drug: PEG-IFNα
PEG-IFNα given by subcutaneous injection
Experimental: Cohort 1d (VIR-3434 + PEG-IFNα)
Participants will receive multiple doses of VIR-3434 + PEG-IFNα for 48 weeks
Drug: VIR-3434
VIR-3434 given by subcutaneous injection
Other Names:
  • Tobevibart
Drug: PEG-IFNα
PEG-IFNα given by subcutaneous injection

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
Proportion of participants with hepatitis B surface antigen (HBsAg) loss (defined as undetectable HBsAg) at end of treatment
Time Frame: Up to 48 weeks
Up to 48 weeks
Proportion of participants with HBsAg loss (defined as undetectable HBsAg) at 24 weeks post-end of treatment
Time Frame: Up to 72 weeks
Up to 72 weeks
Proportion of participants with treatment-emergent adverse events (TEAEs)
Time Frame: Up to 72 weeks
Up to 72 weeks
Proportion of participants with serious adverse events (SAEs)
Time Frame: Up to 72 weeks
Up to 72 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
Absolute serum HBsAg and change from baseline across all timepoints in the study
Time Frame: Up to 110 weeks
Up to 110 weeks
Nadir and maximum reduction of serum HBsAg from baseline
Time Frame: Up to 110 weeks
Up to 110 weeks
Proportion of participants achieving sustained suppression of HBV DNA (< lower limit of quantification (LLOQ) for >= 24 weeks after discontinuation of all treatment, including NRTIs)
Time Frame: Up to 110 weeks
Up to 110 weeks
For hepatitis B e-antigen (HBeAg)-positive participants: Proportion of participants with HBeAg loss (undetectable HBeAg) and/or anti-HBe seroconversion at any timepoint
Time Frame: Up to 110 weeks
Up to 110 weeks
For HBeAg-positive participants: Time to HBeAg loss (undetectable HBeAg) and/or anti-HBe seroconversion
Time Frame: Up to 110 weeks
Up to 110 weeks
Cmax
Time Frame: Up to 110 weeks
Up to 110 weeks
AUClast
Time Frame: Up to 110 weeks
Up to 110 weeks
t1/2
Time Frame: Up to 110 weeks
Up to 110 weeks
CL/F
Time Frame: Up to 110 weeks
Up to 110 weeks
Number of participants with incidence and titers of anti-drug antibody (ADA) (if applicable) to VIR-3434
Time Frame: Up to 110 weeks
Up to 110 weeks
Proportion of participants meeting criteria for nucleotide reverse transcriptase inhibitors (NRTI) discontinuation
Time Frame: Up to 60 weeks
Up to 60 weeks
Proportion of participants meeting criteria for NRTI retreatment
Time Frame: Up to 110 weeks
Up to 110 weeks
Proportion of participants achieving undetectable HBsAg and sustained suppression of HBV DNA [below the LLOQ, target not detected (TND)] >/= 24 weeks after discontinuation of all treatment, including NRTIs
Time Frame: Up to 110 weeks
Up to 110 weeks
Proportion of participants with serum HBsAg < 10 IU/mL at end of treatment
Time Frame: Up to 48 weeks
Up to 48 weeks
Proportion of participants with serum HBsAg < 10 IU/mL at 24 weeks post-end of treatment
Time Frame: Up to 72 weeks
48 weeks treatment + 24 weeks post-end of treatment
Up to 72 weeks
Proportion of participants with anti-HBs seroconversion
Time Frame: Up to 110 weeks
Up to 110 weeks
Time to achieve nadir of serum HBsAg
Time Frame: Up to 110 weeks
Up to 110 weeks
Time to achieve serum HBsAg loss
Time Frame: Up to 110 weeks
Up to 110 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.

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 11, 2021

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 16, 2026

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 16, 2026

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).
April 21, 2021

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.
April 21, 2021

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.
April 22, 2021

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 23, 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.
April 21, 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-2218-1006

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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