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
Conditions the study is for: For Treatment of Chronic Hepatitis B Virus Infection
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

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.

City, postcode or hospital

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)

Conditions: For Treatment of Chronic Hepatitis B Virus Infection
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 group	Role	What they receive
BRII-179 (longer dose interval) followed by BRII-835 + PEG-IFNα	Experimental	Participants 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-IFNα	Experimental	Participants 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.

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)

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
Percentage of participants with treatment-emergent adverse events (TEAEs)
Measured: End of Study
Percentage of participants with serious adverse events (SAEs)
Measured: End of Study
Clinical assessments including laboratory measurements
Measured: End of Study
Appearance of anti-HBs at any timepoint
Measured: End of Study
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.

6 Aug 20245 Aug 2026

First posted9 Jul 2024
Study start6 Aug 2024
Primary completion5 Aug 2026
Study completion5 Aug 2026

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for For Treatment of Chronic Hepatitis B Virus InfectionStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

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