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New combo aims to clear hepatitis b virus in 86-Patient trial

NCT ID NCT05970289

Disease control 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 This study
Running, but no longer taking on new participants.
Completed
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 26, 2026 · Last updated Jun 26, 2026

Summary

This phase 2 study tests whether adding the experimental drug BRII-835 to standard pegylated interferon can help people with chronic hepatitis B lose the virus surface antigen (HBsAg), a key marker of infection. Eighty-six adults on stable antiviral therapy will receive either interferon alone or with different doses of BRII-835. The goal is to see if the combination can achieve better viral control and possibly allow patients to stop long-term medication.

What this could mean

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

Active substance
BRII-835 (a drug) and pegylated interferon alpha (a biologic)
What this could lead to
If successful, this combination could help more people with chronic hepatitis B clear the virus surface antigen, potentially leading to long-term disease control without daily medication.
What could go wrong
This is a mid-stage trial with only 86 participants, so results may not apply to everyone. Side effects from interferon are common, and the treatment may not work for all.

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

86 people

The number who actually took part.

Started

Aug 2023

Expected to finish

Feb 2026

An estimate. End dates often move.

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/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.

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Conditions

The condition(s) this trial relates to.

chronic hepatitis B virus infection

As listed by the trial registrant

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

Chronic hepatitis B virus infection

Contacts and locations

Locations

  • Investigative Site 61001

    Kingswood, New South Wales, 2747, Australia

  • Investigative Site 61002

    Birtinya, Queensland, 4575, Australia

  • Investigative Site 61003

    Melbourne, Victoria, 3004, Australia

  • Investigative Site 65001

    Singapore, 169856, Singapore

  • Investigative Site 65002

    Singapore, 529889, Singapore

  • Investigative Site 66003

    Bangkok, 10330, Thailand

  • Investigative Site 66005

    Khon Kaen, 40002, Thailand

  • Investigative Site 66006

    Nonthaburi, 11000, Thailand

  • Investigative Site 66008

    Songkhla, 90110, Thailand

  • Investigative Site 82001

    Busan, 49241, South Korea

  • Investigative Site 82002

    Chuncheon, Chuncheon-si, 24253, South Korea

  • Investigative Site 82003

    Seoul, 6351, South Korea

  • Investigative Site 82004

    Daegu, 41566, South Korea

  • Investigative Site 82005

    Seoul, 13496, South Korea

  • Investigative Site 82006

    Soeul, 05505, South Korea

  • Investigative Site 85201

    Hong Kong, HONG KONG, 999077, China

  • Investigative Site 85202

    Hong Kong, HONG KONG, 999077, China

  • Investigative Site 86001

    Beijing, Beijing Municipality, 100000, China

  • Investigative Site 86001

    Beijing, Beijing Municipality, 100050, China

  • Investigative Site 86004

    Chongqing, Chongqing Municipality, 400010, China

  • Investigative Site 86006

    Guangzhou, Guangdong, 510630, China

  • Investigative Site 86007

    Beijing, Beijing Municipality, 100069, China

  • Investigative Site 86008

    Changchun, Jilin, 130021, China

  • Investigative Site 86011

    Hangzhou, Zhengjiang, 310016, China

  • Investigative Site 86013

    Shanghai, Shanghai Municipality, 200025, China

  • Investigative Site 88601

    Kaohsiung, Taiwan, 80756, China

  • Investigative Site 88602

    Taipei, Taiwan, 10041, China

  • Investigative Site 88603

    Taipei, Taiwan, 11217, China

  • nvestigative Site 66007

    Chiang Mai, 50200, Thailand

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