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OpenTrials
Active, Not Recruiting

NCT Number: NCT05970289

Investigate the Efficacy and Safety of BRII-835 (VIR-2218) and PEG-IFNα Combination Therapy in Chronic HBV Patients

This study will evaluate the efficacy and safety of PEG-IFNα alone or in combination with different dose levels of BRII-835 (VIR-2218) in participants with chronic hepatitis B virus (HBV) infection.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

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

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Investigative Site 61001, Kingswood, New South Wales, Australia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Male or female aged 18-60.
  • Body mass index ≥ 18 kg/m2 and ≤ 32 kg/m2.
  • Chronic HBV infection for ≥ 6 months.
  • On NRTI therapy for at least 6 months.

Exclusion criteria

  • Any clinically significant chronic or acute medical condition that makes the participant unsuitable for participation.
  • Significant liver 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.
  • Contraindications to the use of Peg-IFNα.

Treatment and study plan

PEG-IFNα

Biological

PEG-IFNα will be given via subcutaneous injection

Other names: pegylated interferon alfa

BRII-835

Drug

BRII-835 will be given via subcutaneous injection

Primary outcomes

  1. Proportion of participants with HBsAg loss at end of treatment

    Time frame: Up to Week 48

  2. Proportion of participants with HBsAg loss at 24 weeks post-end of treatment

    Time frame: Up to Week 72

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

    Time frame: Up to Week 72

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

    Time frame: Up to Week 72

Sponsors and collaborators

Lead sponsor

Brii Biosciences Limited

Industry

Collaborators

  • Vir Biotechnology, Inc.

Registry information

Official study title

A Phase 2 Multicenter, Randomized, Open-label Study to Investigate the Efficacy and Safety of BRII-835 (VIR-2218) and Pegylated Interferon Alpha (PEG-IFNα) Combination Therapy for the Treatment of Chronic Hepatitis B Virus (HBV) Infection

Important dates

Study start
2023
Primary completion
2025
Study completion
2026
First posted
Aug 1, 2023
Registry last updated
Sep 5, 2025

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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