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Completed

NCT Number: NCT04749368

Study to Investigate the Safety and Efficacy of BRII-835 and BRII-179 Combination Therapy Treating Chronic Hepatitis B Virus (HBV) Infection

This is an open label, randomized, parallel-group study to evaluate the safety and efficacy of combination treatment BRII-835 (VIR-2218) and BRII-179 (VBI-2601) in adult participants with chronic HBV infection

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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–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Investigative Site 61002, Kingswood, New South Wales, Australia

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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 aged 18 - 60
  • Body mass index ≥ 18 kg/m^2 and ≤ 32 kg/m^2
  • Chronic HBV infection as defined by a positive serum HBsAg 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 or IM injection
  • History of chronic liver disease from any cause other than chronic HBV infection
  • History of hepatic decompensation

Treatment and study plan

BRII-835 (VIR-2218)

Drug

BRII-835 (VIR-2218) will be given by subcutaneous injection

BRII-179 (VBI-2601) with IFN-α

Biological

BRII-179 (VBI-2601) with IFN-α will be co-administered by intramuscular injection

BRII-179 (VBI-2601)

Biological

BRII-179 (VBI-2601) will be administered by intramuscular injection

Primary outcomes

  1. Percentage of Participants With Sustained HBsAg Loss During the 48-week Follow-up Period After NRTI Withdrawal

    Time frame: Up to Week 96

    Sustained HBsAg loss was defined as undetectable HBsAg < 0.05 IU/mL for at least 24 weeks during the 48-week follow-up period after NRTI withdrawal

  2. Number of Participants With Adverse Events (AE)

    Time frame: Up to Week 96

    Treatment-emergent adverse events (TEAEs) were summarized for each cohort

  3. Number of Participants With Serious Adverse Events (SAE)

    Time frame: Up to Week 96

    Serious adverse events (SAEs) were summarized for each cohort

  4. Number of Participants With Abnormalities in Clinical Laboratory Tests

    Time frame: Up to Week 96

    Treatment-emergent laboratory abnormalities of at least grade 3 are summarized for each cohort

Secondary outcomes

  1. Percentage of Participants Meeting the NRTI Withdrawal Criteria at Week 44

    Time frame: Week 44

    Percentage of participants meeting the NRTI withdrawal criteria at Week 44 was summarized for each cohort

  2. Percentage of Participants With HBsAg Loss With or Without Antibodies to Hepatitis B Surface Antigen (Anti-HBs) at Week 72

    Time frame: Week 72

    Percentage of participants with HBsAg loss with or without antibodies to hepatitis B surface antigen (anti-HBs) at Week 72 was summarized for each cohort

  3. Percentage of Participants With HBsAg Loss at Any Timepoint

    Time frame: Up to Week 72

    Percentage of participants with HBsAg loss at any timepoint was summarized for each cohort

  4. Percentage of Participants With HBsAg Seroconversion at Any Timepoint

    Time frame: Up to Week 72

    Percentage of participants with HBsAg seroconversion at any timepoint was summarized for each cohort

  5. Change From Baseline in Serum HBsAg at Week 72

    Time frame: Week 72

    Change from baseline in serum HBsAg at Week 72 was summarized for each cohort

  6. Percentage of Participants With HBeAg Loss and/or Anti-HBe Seroconversion at Week 44 in Those Who Were HBeAg Positive at Screening

    Time frame: Week 44

    Percentage of participants with HBeAg loss and/or anti-HBe seroconversion at Week 44 in those who were HBeAg positive at screening was summarized for each cohort

  7. Change From Baseline in Serum Appearance and/or Titer of Anti-HBs at Any Timepoint

    Time frame: Up to Week 72

    Change from baseline in serum appearance and/or titer of anti-HBs at any timepoint was summarized for each cohort

Sponsors and collaborators

Lead sponsor

Brii Biosciences Limited

Industry

Collaborators

  • VBI Vaccines Inc.
  • Vir Biotechnology, Inc.

Registry information

Official study title

A Phase 2 Multicenter, Randomized, Open-label Study to Investigate the Safety and Efficacy of BRII-835 (VIR-2218) and BRII-179 (VBI-2601) Combination Therapy for the Treatment of Chronic Hepatitis B Virus (HBV) Infection

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Feb 11, 2021
Registry last updated
Jul 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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