Investigate the Efficacy and Safety of BRII-835 (VIR-2218) and PEG-IFNα Combination Therapy in Chronic HBV Patients

NCT05970289 | Active Not Recruiting Phase 2 FDA Drug

• 1 other identifier: BRII-835-002
• Study Type: interventional
• Target: 86
• Locations: 5 countries
• Sites: 29

Brief 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.

Conditions

Chronic Hepatitis B Virus Infection

Outcome Measures

Primary Outcomes (4)

• Proportion of participants with HBsAg loss at end of treatment

  Up to Week 48

• Proportion of participants with HBsAg loss at 24 weeks post-end of treatment

  Up to Week 72

• Proportion of participants with treatment-emergent adverse events (TEAEs)

  Up to Week 72

• Proportion of participants with serious adverse events (SAEs)

  Up to Week 72

Study Arms (4)

Cohort 1

EXPERIMENTAL

Participants will receive multiple doses of PEG-IFNα for 48 weeks.

Biological: PEG-IFNα

Cohort 2

EXPERIMENTAL

Participants will receive multiple doses of higher dose level of BRII-835 + PEG-IFNα for 48 weeks.

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.

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).

Biological: PEG-IFNα; Drug: BRII-835

Interventions

PEG-IFNα BIOLOGICAL

PEG-IFNα will be given via subcutaneous injection

Also known as: pegylated interferon alfa

Cohort 1; Cohort 2; Cohort 3; Cohort 4

BRII-835 DRUG

BRII-835 will be given via subcutaneous injection

Cohort 2; Cohort 3; Cohort 4

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Brii Biosciences Limited: lead
• Vir Biotechnology, Inc.: collaborator

Study Sites (29)

Investigative Site 61001

Kingswood, New South Wales, 2747, Australia

Location

Investigative Site 61002

Birtinya, Queensland, 4575, Australia

Location

Investigative Site 61003

Melbourne, Victoria, 3004, Australia

Location

Investigative Site 86001

Beijing, Beijing Municipality, 100000, China

Location

Investigative Site 86001

Beijing, Beijing Municipality, 100050, China

Location

Investigative Site 86007

Beijing, Beijing Municipality, 100069, China

Location

Investigative Site 86004

Chongqing, Chongqing Municipality, 400010, China

Location

Investigative Site 86006

Guangzhou, Guangdong, 510630, China

Location

Investigative Site 85201

Hong Kong, HONG KONG, 999077, China

Location

Investigative Site 85202

Hong Kong, HONG KONG, 999077, China

Location

Investigative Site 86008

Changchun, Jilin, 130021, China

Location

Investigative Site 86013

Shanghai, Shanghai Municipality, 200025, China

Location

Investigative Site 88601

Kaohsiung, Taiwan, 80756, China

Location

Investigative Site 88602

Taipei, Taiwan, 10041, China

Location

Investigative Site 88603

Taipei, Taiwan, 11217, China

Location

Investigative Site 86011

Hangzhou, Zhengjiang, 310016, China

Location

Investigative Site 65001

Singapore, 169856, Singapore

Location

Investigative Site 65002

Singapore, 529889, Singapore

Location

Investigative Site 82002

Chuncheon, Chuncheon-si, 24253, South Korea

Location

Investigative Site 82001

Busan, 49241, South Korea

Location

Investigative Site 82004

Daegu, 41566, South Korea

Location

Investigative Site 82005

Seoul, 13496, South Korea

Location

Investigative Site 82003

Seoul, 6351, South Korea

Location

Investigative Site 82006

Soeul, 05505, South Korea

Location

Investigative Site 66003

Bangkok, 10330, Thailand

Location

nvestigative Site 66007

Chiang Mai, 50200, Thailand

Location

Investigative Site 66005

Khon Kaen, 40002, Thailand

Location

Investigative Site 66006

Nonthaburi, 11000, Thailand

Location

Investigative Site 66008

Songkhla, 90110, Thailand

Location

Related Publications (1)

• 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. 2025 Nov 7. doi: 10.1038/s41591-025-04049-z. Online ahead of print.

  PMID: 41203919 DERIVED

MeSH Terms

Conditions

Hepatitis B, Chronic

Condition Hierarchy (Ancestors)

Hepatitis B; Blood-Borne Infections; Communicable Diseases; Infections; Hepadnaviridae Infections; DNA Virus Infections; Virus Diseases; Hepatitis, Viral, Human; Hepatitis, Chronic; Hepatitis; Liver Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Xiaofei Chen

  Brii Biosciences Limited

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 21, 2023
• First Posted: August 1, 2023
• Study Start: August 22, 2023
• Primary Completion: July 16, 2025
• Study Completion: February 1, 2026
• Last Updated: September 5, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

TH (5); CN (13); KR (6); AU (3); SG (2)