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For Treatment of Chronic Hepatitis B Virus InfectionPhase 2NCT06491563

Study to Investigate the Efficacy and Safety of Regimens Containing BRII-179, BRII-835, and PEG-IFNα Treating Chronic Hepatitis B Virus (HBV) Infection (ENRICH)

A Phase 2 study testing BRII-179, BRII-835 (VIR-2218) and PEG-IFNα in people with For Treatment of Chronic Hepatitis B Virus Infection, run by Brii Biosciences Limited at 12 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study will evaluate the efficacy and safety of the regimens containing BRII-179, BRII-835, and PEG-IFNα in adult participants with chronic hepatitis B virus (HBV) infection receiving nucleos(t)ide reverse transcriptase inhibitors (NRTIs) as background therapy. Read more about this study

Who is it for?
Ages 18 to 60 years
What is being tested?
BRII-179, BRII-835 (VIR-2218) and PEG-IFNα
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
150 participants
Where
12 sitesChina
Study dates
6 Aug 2024to 5 Aug 2026
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

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

Who cannot join

  • 1. Any clinically significant chronic or acute medical condition that makes the participant unsuitable for participation.
  • 2. Significant liver fibrosis or cirrhosis.
  • 3. History or evidence of drug or alcohol abuse.
  • 4. History of intolerance to SC or IM injection.
  • 5. History of chronic liver disease from any cause other than chronic HBV infection.
  • 6. History of hepatic decompensation.
  • 7. Contraindications to the use of PEG-IFNα.

Trial locations and contacts

12 sites in 1 country.

12 sites in 1 country

China12 sites

  • Investigative Site 86004

    Beijing, Beijing Municipality, 100000

  • Investigative Site 86009

    Beijing, Beijing Municipality, 100000

  • Investigative Site 86007

    Chengdu, Sichuan, 610000

  • Investigative Site 86011

    Chengdu, Sichuan, 610000

  • Investigative Site 86012

    Foshan, Guangdong, 528000

  • Investigative Site 86001

    Guangzhou, Guangdong, 510000

  • Investigative Site 86013

    Guangzhou, Guangdong, 510000

  • Investigative Site 86005

    Hangzhou, Zhejiang, 310000

  • Investigative Site 86003

    Shanghai, Shanghai Municipality, 200000

  • Investigative Site 86008

    Shanghai, Shanghai Municipality, 200000

  • Investigative Site 86002

    Shenzhen, Guangdong, 518000

  • Investigative Site 86015

    Xiamen, Fujian, 361000

Other trials in China

About this study

Official title: A Phase 2 Multicenter, Open-label Study to Investigate the Efficacy and Safety of Regimens Containing BRII-179, BRII-835, and Pegylated Interferon Alpha (PEG-IFNα) for the Treatment of Chronic Hepatitis B Virus (HBV) Infection (ENRICH)

This study will evaluate the efficacy and safety of the regimens containing BRII-179, BRII-835, and PEG-IFNα in adult participants with chronic hepatitis B virus (HBV) infection receiving nucleos(t)ide reverse transcriptase inhibitors (NRTIs) as background therapy.

Being tested
BRII-179, BRII-835 (VIR-2218), PEG-IFNα

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BRII-179Biological

    BRII-179 will be given via intramuscular injection

  • BRII-835 (VIR-2218)Drug

    Also called elebsiran

    BRII-835 will be given via subcutaneous injection

  • PEG-IFNαBiological

    Also called Pegylated interferon alfa

    PEG-IFNα will be given via subcutaneous injection

Study groups in NCT06491563
Study groupRoleWhat they receive
BRII-179 (longer dose interval) followed by BRII-835 + PEG-IFNαExperimentalParticipants will receive BRII-179 of a longer dose interval, followed by BRII-835 and PEG-IFNα combination therapy.
Receives: Biological: BRII-179; Drug: BRII-835 (VIR-2218); Biological: PEG-IFNα
BRII-179 (shorter dose interval) followed by BRII-835 + PEG-IFNαExperimentalParticipants will receive BRII-179 of a shorter dose interval, followed by BRII-835 and PEG-IFNα combination therapy.
Receives: Biological: BRII-179; Drug: BRII-835 (VIR-2218); Biological: PEG-IFNα

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of participants achieving HBsAg seroclearance at 24 weeks post end of study treatment in anti-HBs responders compared with non-responders defined at protocol-specific timepoint

    Measured: 24 weeks post end of treatment

Secondary outcomes (6)

  1. Percentage of participants achieving HBsAg seroclearance at 24 weeks post end of study treatment in anti-HBs responders compared with non-responders defined at protocol-specific timepoint (in participants with lower baseline HBsAg levels)

    Measured: 24 weeks post end of treatment

  2. Percentage of participants with treatment-emergent adverse events (TEAEs)

    Measured: End of Study

  3. Percentage of participants with serious adverse events (SAEs)

    Measured: End of Study

  4. Clinical assessments including laboratory measurements

    Measured: End of Study

  5. Appearance of anti-HBs at any timepoint

    Measured: End of Study

  6. Titers of anti-HBs at any timepoint

    Measured: End of Study

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Jul 2024
  2. Study start6 Aug 2024
  3. Primary completion5 Aug 2026
  4. Study completion5 Aug 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
150 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06491563
Sponsor's protocol ID
BRII-179-835-002
Status last verified
Oct 2026
First submitted
28 Jun 2024
Last updated
21 Oct 2026
Results posted
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing BRII-179, BRII-835 (VIR-2218) and PEG-IFNα in people with For Treatment of Chronic Hepatitis B Virus Infection, run by Brii Biosciences Limited at 12 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 12 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of participants achieving HBsAg seroclearance at 24 weeks post end of study treatment in anti-HBs responders compared with non-responders defined at protocol-specific timepoint (time frame: 24 weeks post end of treatment). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06491563.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2026.

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