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Completed

NCT Number: NCT04856085

Study of 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

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Key information

Conditions

Hepatitis B, Chronic Blood-Borne Infections Chronic Disease Communicable Diseases DNA Virus Infections Digestive System Diseases Disease Attributes Hepadnaviridae Infections Hepatitis Hepatitis B Hepatitis, Chronic Hepatitis, Viral, Human Infections Liver Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Virus Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Investigative Site, Toronto, Canada

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

VIR-2218

Drug

VIR-2218 given by subcutaneous injection

Other names: Elebsiran

VIR-3434

Drug

VIR-3434 given by subcutaneous injection

Other names: Tobevibart

PEG-IFNα

Drug

PEG-IFNα given by subcutaneous injection

Primary outcomes

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

    Time frame: Up to 72 weeks

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

    Time frame: Up to 72 weeks

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

    Time frame: Up to 48 weeks

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

    Time frame: Up to 72 weeks

Secondary outcomes

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

    Time frame: Up to 110 weeks

  2. Nadir and maximum reduction of serum HBsAg from baseline

    Time frame: 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)

    Time frame: 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

    Time frame: Up to 110 weeks

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

    Time frame: Up to 110 weeks

  6. Cmax

    Time frame: Up to 110 weeks

  7. AUClast

    Time frame: Up to 110 weeks

  8. t1/2

    Time frame: Up to 110 weeks

  9. CL/F

    Time frame: Up to 110 weeks

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

    Time frame: Up to 110 weeks

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

    Time frame: Up to 60 weeks

  12. Proportion of participants meeting criteria for NRTI retreatment

    Time frame: 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

    Time frame: Up to 110 weeks

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

    Time frame: Up to 48 weeks

  15. 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

  16. Proportion of participants with anti-HBs seroconversion

    Time frame: Up to 110 weeks

  17. Time to achieve nadir of serum HBsAg

    Time frame: Up to 110 weeks

  18. Time to achieve serum HBsAg loss

    Time frame: Up to 110 weeks

Sponsors and collaborators

Lead sponsor

Vir Biotechnology, Inc.

Industry

Registry information

Official study 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

Acronym: MARCH

Important dates

Study start
2021
Primary completion
2026
Study completion
2026
First posted
Apr 22, 2021
Registry last updated
Apr 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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