AzTrials
AzTrials

Hepatitis B, ChronicPhase 2MARCHNCT04856085

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

A Phase 2 study testing VIR-2218, VIR-3434 and PEG-IFNα in people with Hepatitis B, Chronic, run by Vir Biotechnology, Inc. at 37 sites in 12 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

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 Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Hepatitis B, Chronic
What is being tested?
VIR-2218, VIR-3434 and PEG-IFNα
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
244 participants
Where
37 sitesin 12 countries
Study dates
11 Jul 2021to 16 Mar 2026
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Male or female ages 18 - <66 years
  • Chronic HBV infection for >/= 6 months
  • On NRTI therapy for >/= 2 months at the time of screening

Who cannot join

  • 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
Show all 9Show fewer
  • 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

Trial locations and contacts

37 sites in 12 countries.

37 sites in 12 countries

Taiwan6 sites

  • Investigative Site

    Chiayi City, 60041

  • Investigative Site

    Kaohsiung City, 80756

  • Investigative Site

    Kaohsiung City, 83301

  • Investigative Site

    Taichung, 40705

  • Investigative Site

    Taipei, 100

  • Investigative Site

    Taoyuan City, 33305

Other trials in Taiwan

United States5 sites

  • Investigative Site

    Baltimore, Maryland, 21218

  • Investigative Site

    Hillsborough, New Jersey, 08844

  • Investigative Site

    Miami, Florida, 33136

  • Investigative Site

    Orlando, Florida, 32803

  • Investigative Site

    San Francisco, California, 94143

Other trials in United States

New Zealand5 sites

  • Investigative Site

    Auckland, 1010

  • Investigative Site

    Auckland, 2025

  • Investigative Site

    Hamilton, 3204

  • Investigative Site

    Tauranga, 3110

  • Investigative Site

    Wellington, 6021

Other trials in New Zealand

South Korea4 sites

  • Investigative Site

    Busan, 49421

  • Investigative Site

    Seoul, 03080

  • Investigative Site

    Seoul, 05505

  • Investigative Site

    Yangsan, 50612

Other trials in South Korea

United Kingdom4 sites

  • Investigative Site

    Birmingham, B15 2TH

  • Investigative Site

    London, E11FR

  • Investigative Site

    London, SE5 9RS

  • Investigative Site

    Manchester, M8 5RB

Other trials in United Kingdom

Canada3 sites

  • Investigative Site

    Toronto, 2C4

  • Investigative Site

    Toronto, 3M1

  • Investigative Site

    Vancouver, 2C7

Other trials in Canada

Germany3 sites

  • Investigative Site

    Frankfurt, 60590

  • Investigative Site

    Hanover, 30625

  • Investigative Site

    Mannheim, 68167

Other trials in Germany

Hong Kong3 sites

  • Investigative Site

    Hong Kong, Shatin

  • Investigative Site

    Hong Kong, Tai Po District

  • Investigative Site

    Hong Kong

Other trials in Hong Kong

Malaysia1 site

  • Investigative Site

    Kuala Lumpur, 59100

Other trials in Malaysia

Moldova1 site

  • Investigative Site

    Chisinau, MD 2025

Other trials in Moldova

Romania1 site

  • Investigative Site

    Bucharest, 021105

Other trials in Romania

Ukraine1 site

  • Investigative Site

    Kyiv, 01135

Other trials in Ukraine

About this study

Official title: 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

Being tested
VIR-2218, VIR-3434, PEG-IFNα
Keywords
Hepatitis B Virus, Chronic Hepatitis B, HBV, Hepatitis
Medical subject headings
Hepatitis B, Chronic, Hepatitis B, Hepatitis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • VIR-2218Drug

    Also called Elebsiran

    VIR-2218 given by subcutaneous injection

  • VIR-3434Drug

    Also called Tobevibart

    VIR-3434 given by subcutaneous injection

  • PEG-IFNαDrug

    PEG-IFNα given by subcutaneous injection

Study groups in NCT04856085
Study groupRoleWhat they receive
Cohort 1a (VIR-2218 + VIR-3434)ExperimentalParticipants will receive multiple lead-in doses of VIR-2218, then combination therapy with VIR-2218 + VIR-3434 for 20 weeks total
Receives: Drug: VIR-2218; Drug: VIR-3434
Cohort 2a (VIR-2218 + VIR-3434)ExperimentalParticipants will receive multiple lead-in doses of VIR-2218, then combination therapy with VIR-2218 + VIR-3434 for 20 weeks total
Receives: Drug: VIR-2218; Drug: VIR-3434
Cohort 3a (VIR-2218 + VIR-3434)ExperimentalParticipants will receive multiple doses of VIR-2218 + VIR-3434 for 4 weeks
Receives: Drug: VIR-2218; Drug: VIR-3434
Cohort 4a (VIR-2218 + VIR-3434)ExperimentalParticipants will receive multiple doses of VIR-2218 + VIR-3434 for 4 weeks
Receives: Drug: VIR-2218; Drug: VIR-3434
Cohort 5a (VIR-2218 + VIR-3434)ExperimentalParticipants will receive multiple doses of VIR-2218 + VIR-3434 for 11 weeks
Receives: Drug: VIR-2218; Drug: VIR-3434
Cohort 6a (VIR-2218 + VIR-3434)ExperimentalParticipants will receive multiple doses of VIR-2218 + VIR-3434 for 11 weeks
Receives: Drug: VIR-2218; Drug: VIR-3434
Cohort 7a (VIR-2218 + VIR-3434)ExperimentalParticipants will receive multiple doses of VIR-2218 + VIR-3434 for 44 weeks
Receives: Drug: VIR-2218; Drug: VIR-3434
Cohort 8a (VIR-2218 + VIR-3434)ExperimentalParticipants will receive multiple doses of VIR-2218 + VIR-3434 for 20 weeks
Receives: Drug: VIR-2218; Drug: VIR-3434
Cohort 1b (VIR-3434)ExperimentalParticipants will receive multiple doses of VIR-3434 for 44 weeks
Receives: Drug: VIR-3434
Cohort 2b (VIR-3434)ExperimentalParticipants will receive multiple doses of VIR-3434 for 20 weeks
Receives: Drug: VIR-3434
Cohort 1c (VIR-2218 + VIR-3434 + PEG-IFNα)ExperimentalParticipants will receive multiple doses of VIR-2218 + VIR-3434 + PEG-IFNα for 24 weeks
Receives: Drug: VIR-2218; Drug: VIR-3434; Drug: PEG-IFNα
Cohort 2c (VIR-2218 + VIR-3434 + PEG-IFNα)ExperimentalParticipants will receive multiple doses of VIR-2218 + VIR-3434 + PEG-IFNα for 48 weeks
Receives: Drug: VIR-2218; Drug: VIR-3434; Drug: PEG-IFNα
Cohort 1d (VIR-3434 + PEG-IFNα)ExperimentalParticipants will receive multiple doses of VIR-3434 + PEG-IFNα for 48 weeks
Receives: Drug: VIR-3434; Drug: PEG-IFNα

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Proportion of participants with treatment-emergent adverse events (TEAEs)

    Measured: Up to 72 weeks

  2. Proportion of participants with serious adverse events (SAEs)

    Measured: Up to 72 weeks

  3. Proportion of participants with hepatitis B surface antigen (HBsAg) loss (defined as undetectable HBsAg) at end of treatment

    Measured: Up to 48 weeks

  4. Proportion of participants with HBsAg loss (defined as undetectable HBsAg) at 24 weeks post-end of treatment

    Measured: Up to 72 weeks

Secondary outcomes (18)

  1. Absolute serum HBsAg and change from baseline across all timepoints in the study

    Measured: Up to 110 weeks

  2. Nadir and maximum reduction of serum HBsAg from baseline

    Measured: Up to 110 weeks

  3. Proportion of participants achieving sustained suppression of HBV DNA (< lower limit of quantification (LLOQ) for >= 24 weeks after discontinuation of all treatment, including NRTIs)

    Measured: Up to 110 weeks

  4. For hepatitis B e-antigen (HBeAg)-positive participants: Proportion of participants with HBeAg loss (undetectable HBeAg) and/or anti-HBe seroconversion at any timepoint

    Measured: Up to 110 weeks

  5. For HBeAg-positive participants: Time to HBeAg loss (undetectable HBeAg) and/or anti-HBe seroconversion

    Measured: Up to 110 weeks

  6. Cmax

    Measured: Up to 110 weeks

  7. AUClast

    Measured: Up to 110 weeks

  8. t1/2

    Measured: Up to 110 weeks

  9. CL/F

    Measured: Up to 110 weeks

  10. Number of participants with incidence and titers of anti-drug antibody (ADA) (if applicable) to VIR-3434

    Measured: Up to 110 weeks

  11. Proportion of participants meeting criteria for nucleotide reverse transcriptase inhibitors (NRTI) discontinuation

    Measured: Up to 60 weeks

  12. Proportion of participants meeting criteria for NRTI retreatment

    Measured: Up to 110 weeks

  13. 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

    Measured: Up to 110 weeks

  14. Proportion of participants with serum HBsAg < 10 IU/mL at end of treatment

    Measured: Up to 48 weeks

  15. Proportion of participants with serum HBsAg < 10 IU/mL at 24 weeks post-end of treatment

    48 weeks treatment + 24 weeks post-end of treatment

    Measured: Up to 72 weeks

  16. Proportion of participants with anti-HBs seroconversion

    Measured: Up to 110 weeks

  17. Time to achieve nadir of serum HBsAg

    Measured: Up to 110 weeks

  18. Time to achieve serum HBsAg loss

    Measured: Up to 110 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Apr 2021
  2. Study start11 Jul 2021
  3. Primary completion16 Mar 2026
  4. Study completion16 Mar 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
244 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04856085
Sponsor's protocol ID
VIR-2218-1006
Acronym
MARCH
Status last verified
Mar 2026
First submitted
21 Apr 2021
Last updated
23 Apr 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Noack J, Anglero-Rodriguez Y, Gall J, Zhou J, LeBlanc S, Liebow A, Bakardjiev A, Hebner CM, Purcell LA, Jadhav V, Corti D, Lempp FA. Combination therapy with tobevibart and elebsiran potently reduces hepatitis B virus surface antigen levels in preclinical in vivo models. Antimicrob Agents Chemother. 2026 Mar 4;70(3):e0112725. doi: 10.1128/aac.01127-25. Epub 2026 Jan 26.

    PubMed 41586499

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing VIR-2218, VIR-3434 and PEG-IFNα in people with Hepatitis B, Chronic, run by Vir Biotechnology, Inc. at 37 sites in 12 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 37 sites in Taiwan, United States, New Zealand, South Korea, United Kingdom and 7 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of participants with treatment-emergent adverse events (TEAEs) (time frame: Up to 72 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04856085, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Apr 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in