Study to Investigate the Safety and Efficacy of BRII-835 and BRII-179 Combination Therapy Treating Chronic Hepatitis B Virus (HBV) Infection

NCT04749368 | Completed Phase 2 Results FDA Drug

• 1 other identifier: BRII-179-835-001
• Study Type: interventional
• Target: 91
• Locations: 6 countries
• Sites: 28

Brief Summary

This is an open label, randomized, parallel-group study to evaluate the safety and efficacy of combination treatment BRII-835 (VIR-2218) and BRII-179 (VBI-2601) in adult participants with chronic HBV infection

Conditions

Hepatitis B, Chronic

Keywords

Hepatitis B Virus; Chronic Hepatitis B; HBV; Hepatitis

Outcome Measures

Primary Outcomes (4)

• Percentage of Participants With Sustained HBsAg Loss During the 48-week Follow-up Period After NRTI Withdrawal

  Sustained HBsAg loss was defined as undetectable HBsAg \< 0.05 IU/mL for at least 24 weeks during the 48-week follow-up period after NRTI withdrawal

  Up to Week 96

• Number of Participants With Adverse Events (AE)

  Treatment-emergent adverse events (TEAEs) were summarized for each cohort

  Up to Week 96

• Number of Participants With Serious Adverse Events (SAE)

  Serious adverse events (SAEs) were summarized for each cohort

  Up to Week 96

• Number of Participants With Abnormalities in Clinical Laboratory Tests

  Treatment-emergent laboratory abnormalities of at least grade 3 are summarized for each cohort

  Up to Week 96

Secondary Outcomes (7)

• Percentage of Participants Meeting the NRTI Withdrawal Criteria at Week 44

  Week 44

• Percentage of Participants With HBsAg Loss With or Without Antibodies to Hepatitis B Surface Antigen (Anti-HBs) at Week 72

  Week 72

• Percentage of Participants With HBsAg Loss at Any Timepoint

  Up to Week 72

• Percentage of Participants With HBsAg Seroconversion at Any Timepoint

  Up to Week 72

• Change From Baseline in Serum HBsAg at Week 72

  Week 72

Study Arms (3)

Cohort A

EXPERIMENTAL

Participants will receive BRII-835 (VIR-2218) for 32 weeks

Drug: BRII-835 (VIR-2218)

Cohort B

EXPERIMENTAL

Participants will receive BRII-835 (VIR-2218) and BRII-179 (VBI-2601) with IFN-α up to Week 40

Drug: BRII-835 (VIR-2218); Biological: BRII-179 (VBI-2601) with IFN-α

Cohort C

EXPERIMENTAL

Participant will receive BRII-835 (VIR-2218) and BRII-179 (VBI-2601) up to Week 40

Drug: BRII-835 (VIR-2218); Biological: BRII-179 (VBI-2601)

Interventions

BRII-835 (VIR-2218) DRUG

BRII-835 (VIR-2218) will be given by subcutaneous injection

Cohort A; Cohort B; Cohort C

BRII-179 (VBI-2601) BIOLOGICAL

BRII-179 (VBI-2601) will be administered by intramuscular injection

Cohort C

BRII-179 (VBI-2601) with IFN-α BIOLOGICAL

BRII-179 (VBI-2601) with IFN-α will be co-administered by intramuscular injection

Cohort B

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/m\^2 and ≤ 32 kg/m\^2
• Chronic HBV infection as defined by a positive serum HBsAg for ≥ 6 months

You may not qualify if:

• Any clinically significant chronic or acute medical condition that makes the volunteer unsuitable for participation
• Significant fibrosis or cirrhosis
• History or evidence of drug or alcohol abuse
• History of intolerance to SC or IM injection
• History of chronic liver disease from any cause other than chronic HBV infection
• History of hepatic decompensation

Sponsors & Collaborators

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

Study Sites (28)

Investigative Site 61002

Kingswood, New South Wales, 2747, Australia

Location

Investigative Site 61001

Westmead, New South Wales, 2145, Australia

Location

Investigative Site 61004

Herston, Queensland, 4029, Australia

Location

Investigative Site 88602

Changhua, Taiwan, 500, China

Location

Investigative Site 85201

Hong Kong, China

Location

Investigative Site 85202

Hong Kong, China

Location

Investigative Site 85203

Hong Kong, China

Location

Investigative Site 88601

Kaohsiung, Taiwan, 83301, China

Location

Investigative Site 88604

Kaohsiung, Taiwan, China

Location

Investigative Site 85204

NEW Territories, Hong Kong, China

Location

Investigative Site 88603

Taichung, Taiwan, 40447, China

Location

Investigative Site 88605

Taipei CITY, 10048, China

Location

Investigative Site 64002

Dunedin Central, Dunedin, 9016, New Zealand

Location

Investigative Site 64001

Auckland, 2025, New Zealand

Location

Investigative Site 65001

Singapore, 169608, Singapore

Location

Investigative Site 65002

Singapore, 529889, Singapore

Location

Investigative Site 82004

Busan, 49241, South Korea

Location

Investigative Site 82003

Seongnam-si, Gyeonggi-do, 13496, South Korea

Location

Investigative Site 82001

Seoul, 3080, South Korea

Location

Investigative Site 82005

Seoul, 3722, South Korea

Location

Investigative Site 82002

Seoul, 5505, South Korea

Location

Investigative Site 66001

Bangkok, 10330, Thailand

Location

Investigative Site 66003

Chiang Mai, 50200, Thailand

Location

Investigative Site 66002

Khon Kaen, 40002, Thailand

Location

Investigative Site 66005

Nonthaburi, 11000, Thailand

Location

Investigative Site 66006

Nonthaburi, 11000, Thailand

Location

Investigative Site 66004

Pathum Thani, 12120, Thailand

Location

Investigative Site 66007

Songkhla, 90110, Thailand

Location

Related Publications (1)

• Ji Y, Le Bert N, Lai-Hung Wong G, Douglas MW, Lee A, Zhu C, Wang B, Lv J, Li D, Tan Y, Ma H, Chen J, Chen X, Zhu Q, Yuen MF, Bertoletti A. The Impact of Hepatitis B Surface Antigen Reduction via Small Interfering RNA Treatment on Natural and Vaccine (BRII-179)-Induced Hepatitis B Virus-Specific Humoral and Cellular Immune Responses. Gastroenterology. 2025 Jul;169(1):136-149. doi: 10.1053/j.gastro.2025.02.016. Epub 2025 Mar 3.

  PMID: 40043858 DERIVED

MeSH Terms

Conditions

Hepatitis B, Chronic; Hepatitis B; Hepatitis

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Clinical Research
• Organization: Brii Biosciences Limited

clinicaltrials@briibio.com

86 10 6299 8808

Study Officials

• Xiaofei Chen

  Brii Biosciences Limited

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

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: February 7, 2021
• First Posted: February 11, 2021
• Study Start: April 12, 2021
• Primary Completion: July 4, 2023
• Study Completion: July 4, 2023
• Last Updated: July 23, 2026
• Results First Posted: July 23, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

SG (2); AU (3); KR (5); TH (7); CN (9); NZ (2)