Chronic Hepatitis B Virus InfectionPhase 2NCT05970289
Investigate the Efficacy and Safety of BRII-835 (VIR-2218) and PEG-IFNα Combination Therapy in Chronic HBV Patients
A Phase 2 study testing PEG-IFNα and BRII-835 in people with Chronic Hepatitis B Virus Infection, run by Brii Biosciences Limited at 28 sites in 5 countries.
Trial summary
This study will evaluate the efficacy and safety of PEG-IFNα alone or in combination with different dose levels of BRII-835 (VIR-2218) in participants with chronic hepatitis B virus (HBV) infection. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Chronic Hepatitis B Virus Infection
- What is being tested?
- PEG-IFNα and BRII-835
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 86 participants
- Where
- 28 sitesin 5 countries
- Study dates
- 22 Aug 2023to 23 Jan 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
- 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.
Who cannot join
- 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.
Trial locations and contacts
28 sites in 5 countries.
28 sites in 5 countries
China12 sites
Investigative Site 86001
Beijing, Beijing Municipality, 100000
Investigative Site 86007
Beijing, Beijing Municipality, 100069
Investigative Site 86008
Changchun, Jilin, 130021
Investigative Site 86004
Chongqing, Chongqing Municipality, 400010
Investigative Site 86006
Guangzhou, Guangdong, 510630
Investigative Site 86011
Hangzhou, Zhengjiang, 310016
Investigative Site 85201
Hong Kong, HONG KONG, 999077
Investigative Site 85202
Hong Kong, HONG KONG, 999077
Investigative Site 88601
Kaohsiung, Taiwan, 80756
Investigative Site 86013
Shanghai, Shanghai Municipality, 200025
Investigative Site 88602
Taipei, Taiwan, 10041
Investigative Site 88603
Taipei, Taiwan, 11217
South Korea6 sites
Investigative Site 82001
Busan, Busan, 49241
Investigative Site 82002
Chuncheon, CHUNCHEON-SI, 24253
Investigative Site 82004
Daegu, Daegu, 41566
Investigative Site 82003
Seoul, Seoul, 6351
Investigative Site 82005
Seoul, 13496
Investigative Site 82006
Soeul, 05505
Thailand5 sites
Investigative Site 66003
Bangkok, Bangkok, 10330
nvestigative Site 66007
Chiang Mai, 50200
Investigative Site 66005
Khon Kaen, Changwat Khon Kaen, 40002
Investigative Site 66006
Nonthaburi, Changwat Nonthaburi, 11000
Investigative Site 66008
Songkhla, 90110
Australia3 sites
Investigative Site 61002
Birtinya, Queensland, 4575
Investigative Site 61001
Kingswood, New South Wales, 2747
Investigative Site 61003
Melbourne, Victoria, 3004
Singapore2 sites
Investigative Site 65001
Singapore, Singapore, 169856
Investigative Site 65002
Singapore, Singapore, 529889
About this study
Official title: A Phase 2 Multicenter, Randomized, Open-label Study to Investigate the Efficacy and Safety of BRII-835 (VIR-2218) and Pegylated Interferon Alpha (PEG-IFNα) Combination Therapy for the Treatment of Chronic Hepatitis B Virus (HBV) Infection
This study will evaluate the efficacy and safety of PEG-IFNα alone or in combination with different dose levels of BRII-835 (VIR-2218) in participants with chronic hepatitis B virus (HBV) infection.
- Conditions
- Chronic Hepatitis B Virus Infection
- Being tested
- PEG-IFNα, BRII-835
- Medical subject headings
- Hepatitis B, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PEG-IFNαBiological
Also called pegylated interferon alfa
PEG-IFNα will be given via subcutaneous injection
BRII-835Drug
BRII-835 will be given via subcutaneous injection
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Experimental | Participants will receive multiple doses of PEG-IFNα for 48 weeks. Receives: Biological: PEG-IFNα |
| Cohort 2 | Experimental | Participants will receive multiple doses of higher dose level of BRII-835 + PEG-IFNα for 48 weeks. Receives: Biological: PEG-IFNα; Drug: BRII-835 |
| Cohort 3 | Experimental | Participants will receive multiple doses of lower dose level of BRII-835 + PEG-IFNα for 48 weeks. Receives: Biological: PEG-IFNα; Drug: BRII-835 |
| Cohort 4 | Experimental | Participants will receive multiple doses of lower dose level of BRII-835 + PEG-IFNα for 48 weeks (participants who received BRII-179 in a previous study will roll over into this cohort). Receives: Biological: PEG-IFNα; Drug: BRII-835 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of participants with HBsAg loss at end of treatment
Measured: Up to Week 48
Proportion of participants with HBsAg loss at 24 weeks post-end of treatment
Measured: Up to Week 72
Proportion of participants with treatment-emergent adverse events (TEAEs)
Measured: Up to Week 72
Proportion of participants with serious adverse events (SAEs)
Measured: Up to Week 72
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2023
- Study start22 Aug 2023
- Primary completion16 Jul 2025
- Study completion23 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 86 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brii Biosciences Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Vir Biotechnology, Inc.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05970289
- Sponsor's protocol ID
- BRII-835-002
- Status last verified
- Oct 2026
- First submitted
- 21 Jul 2023
- Last updated
- 20 Oct 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Wong GL, Yuen MF, Lin B, Douglas MW, Hu P, Xie Q, Lv F, Tak WY, Leerapun A, Kim DJ, Tangkijvanich P, Lim YS, Dai CY, O'Beirne J, Weltman M, Khemnark S, Piratvisuth T, Manasirisuk W, Chen X, Liu CJ, Heo J, Lee J, Niu J, Kumar R, Kumar R, Zhu C, Cao K, Tian A, Chen X, Zhu Q, Margolis D, Jia J, Hong Z. Elebsiran and PEG-IFNalpha for chronic hepatitis B infection: a partially randomized, open-label, phase 2 trial. Nat Med. 2026 Jan;32(1):151-159. doi: 10.1038/s41591-025-04049-z. Epub 2025 Nov 7.
PubMed 41203919
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Multicenter, Randomized, Open-label Study to Investigate the Efficacy and Safety of BRII-835 (VIR-2218) and Pegylated Interferon Alpha (PEG-IFNα) Combination Therapy for the Treatment of Chronic Hepatitis B Virus (HBV) Infection
- ClinicalTrials.gov ID
- NCT05970289
- Acronym / sponsor ID
- BRII-835-002
- Conditions
- Chronic Hepatitis B Virus Infection
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 86 participants (actual)
- Lead sponsor
- Brii Biosciences LimitedIndustry (pharma, biotech, devices)
- Collaborators
- Vir Biotechnology, Inc.
- Study start
- 22 Aug 2023 (actual)
- Primary completion
- 16 Jul 2025 (actual)
- Study completion
- 23 Jan 2026 (actual)
- First posted
- 1 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will evaluate the efficacy and safety of PEG-IFNα alone or in combination with different dose levels of BRII-835 (VIR-2218) in participants with chronic hepatitis B virus (HBV) infection.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Experimental | Biological: PEG-IFNαParticipants will receive multiple doses of PEG-IFNα for 48 weeks. |
| Cohort 2 | Experimental | Biological: PEG-IFNα, Drug: BRII-835Participants will receive multiple doses of higher dose level of BRII-835 + PEG-IFNα for 48 weeks. |
| Cohort 3 | Experimental | Biological: PEG-IFNα, Drug: BRII-835Participants will receive multiple doses of lower dose level of BRII-835 + PEG-IFNα for 48 weeks. |
| Cohort 4 | Experimental | Biological: PEG-IFNα, Drug: BRII-835Participants will receive multiple doses of lower dose level of BRII-835 + PEG-IFNα for 48 weeks (participants who received BRII-179 in a previous study will roll over into this cohort). |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PEG-IFNαAlso: pegylated interferon alfaPEG-IFNα will be given via subcutaneous injection | Biological | Cohort 1, Cohort 2, Cohort 3, Cohort 4 |
| BRII-835BRII-835 will be given via subcutaneous injection | Drug | Cohort 2, Cohort 3, Cohort 4 |
Primary outcome
Proportion of participants with HBsAg loss at end of treatment
Time frame: Up to Week 48
Proportion of participants with HBsAg loss at 24 weeks post-end of treatment
Time frame: Up to Week 72
Proportion of participants with treatment-emergent adverse events (TEAEs)
Time frame: Up to Week 72
Proportion of participants with serious adverse events (SAEs)
Time frame: Up to Week 72
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2026.
- Derived from this study: PubMed 41203919Wong GL, Yuen MF, Lin B, Douglas MW, Hu P, Xie Q, Lv F, Tak WY, Leerapun A, Kim DJ, Tangkijvanich P, Lim YS, Dai CY, O'Beirne J, Weltman M, Khemnark S, Piratvisuth T, Manasirisuk W, Chen X, Liu CJ, Heo J, Lee J, Niu J, Kumar R, Kumar R, Zhu C, Cao K, Tian A, Chen X, Zhu Q, Margolis D, Jia J, Hong Z. Elebsiran and PEG-IFNalpha for chronic hepatitis B infection: a partially randomized, open-label, phase 2 trial. Nat Med. 2026 Jan;32(1):151-159. doi: 10.1038/s41591-025-04049-z. Epub 2025 Nov 7.
- Individual participant dataSharing planned: No
Related trials for Chronic Hepatitis B Virus Infection
Active, not recruitingPhase 2
A Study of Sequential Therapy With Daplusiran/Tomligisiran (DAP/TOM) Followed by Bepirovirsen in Participants Living With Chronic Hepatitis B (CHB)
Chronic Hepatitis B Virus Infection, Hepatitis B
RecruitingObservational study
Evaluation of Patients With Liver Disease
Hepatitis D, Hepatitis C
Active, not recruitingPhase 2
Study of Bepirovirsen in Participants Living With Human Immunodeficiency Virus and Chronic Hepatitis B Virus Infection (B-Focus)
Hepatitis B
Active, not recruitingPhase 2
Long-term Follow-up Study to Evaluate Durability of Treatment Response in Previous Bepirovirsen Study Participants (B-Sure)
Hepatitis B
Enrolling by invitationPhase 1
A Phase I Clinical Trial of CPU-YL01 Injection in Patients With Chronic Hepatitis B.
Chronic Hepatitis B
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
28 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing PEG-IFNα and BRII-835 in people with Chronic Hepatitis B Virus Infection, run by Brii Biosciences Limited at 28 sites in 5 countries.
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 20 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 28 sites in China, South Korea, Thailand, Australia, Singapore. 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?
Proportion of participants with HBsAg loss at end of treatment (time frame: Up to Week 48). The study lists 4 primary outcomes in all. 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 NCT05970289, which also lists 1 linked publication.
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 20 Oct 2026.