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Can a Two-Drug combo finally beat chronic hepatitis b?

NCT ID NCT04749368

Cure Sponsor: Brii Biosciences Limited Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 23, 2026 · Last updated Jul 24, 2026 · Updated 1 time

Summary

This phase 2 trial is testing whether a combination of two experimental drugs, BRII-835 and BRII-179, can clear the hepatitis B virus from the body in adults with chronic infection. Participants will receive the drug combination and then be monitored to see if they can safely stop their standard antiviral therapy. The goal is to achieve a sustained loss of hepatitis B surface antigen, a key marker of infection, which could point toward a functional cure.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
a combination of two experimental drugs: BRII-835 (VIR-2218) and BRII-179 (VBI-2601)
What this could lead to
If successful, this combination could offer a functional cure for chronic hepatitis B, allowing patients to stop long-term antiviral treatment.
What could go wrong
This is an early-phase trial with a small number of participants. The drugs may not achieve sustained virus clearance, and side effects or safety issues could emerge.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

91 people

The number who actually took part.

Started

Apr 2021

Finished

Jul 2023

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 60 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

chronic hepatitis B virus infection hepatitis hepatitis B virus infection

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Hepatitis B, chronic

Contacts and locations

Locations

  • Investigative Site 61001

    Westmead, New South Wales, 2145, Australia

  • Investigative Site 61002

    Kingswood, New South Wales, 2747, Australia

  • Investigative Site 61004

    Herston, Queensland, 4029, Australia

  • Investigative Site 64001

    Auckland, 2025, New Zealand

  • Investigative Site 64002

    Dunedin Central, Dunedin, 9016, New Zealand

  • Investigative Site 65001

    Singapore, 169608, Singapore

  • Investigative Site 65002

    Singapore, 529889, Singapore

  • Investigative Site 66001

    Bangkok, 10330, Thailand

  • Investigative Site 66002

    Khon Kaen, 40002, Thailand

  • Investigative Site 66003

    Chiang Mai, 50200, Thailand

  • Investigative Site 66004

    Pathum Thani, 12120, Thailand

  • Investigative Site 66005

    Nonthaburi, 11000, Thailand

  • Investigative Site 66006

    Nonthaburi, 11000, Thailand

  • Investigative Site 66007

    Songkhla, 90110, Thailand

  • Investigative Site 82001

    Seoul, 3080, South Korea

  • Investigative Site 82002

    Seoul, 5505, South Korea

  • Investigative Site 82003

    Seongnam-si, Gyeonggi-do, 13496, South Korea

  • Investigative Site 82004

    Busan, 49241, South Korea

  • Investigative Site 82005

    Seoul, 3722, South Korea

  • Investigative Site 85201

    Hong Kong, China

  • Investigative Site 85202

    Hong Kong, China

  • Investigative Site 85203

    Hong Kong, China

  • Investigative Site 85204

    NEW Territories, Hong Kong, China

  • Investigative Site 88601

    Kaohsiung, Taiwan, 83301, China

  • Investigative Site 88602

    Changhua, Taiwan, 500, China

  • Investigative Site 88603

    Taichung, Taiwan, 40447, China

  • Investigative Site 88604

    Kaohsiung, Taiwan, China

  • Investigative Site 88605

    Taipei CITY, 10048, China

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