Study to Investigate the Safety and Efficacy of BRII-835 and BRII-179 Combination Therapy Treating Chronic HBV Infection

October 9, 2023 updated by: Brii Biosciences Limited

A Phase 2 Multicenter, Randomized, Open-label Study to Investigate the Safety and Efficacy of BRII-835 (VIR-2218) and BRII-179 (VBI-2601) Combination Therapy for the Treatment of Chronic Hepatitis B Virus (HBV) Infection

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

91

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • New South Wales
      • Kingswood, New South Wales, Australia, 2747
        • Investigative Site 61002
      • Westmead, New South Wales, Australia, 2145
        • Investigative Site 61001
    • Queensland
      • Herston, Queensland, Australia, 4029
        • Investigative Site 61004
  • China
      • Changhua, Taiwan, China, 500
        • Investigative Site 88602
      • Hongkong, China
        • Investigative Site 85201
      • Hongkong, China
        • Investigative Site 85202
      • Hongkong, China
        • Investigative Site 85203
      • Kaohsiung, Taiwan, China, 83301
        • Investigative Site 88601
      • Kaohsiung, Taiwan, China
        • Investigative Site 88604
      • NEW Territories, Hong Kong, China
        • Investigative Site 85204
      • Taichung, Taiwan, China, 40447
        • Investigative Site 88603
      • Taipei CITY, China, 10048
        • Investigative Site 88605
  • Korea, Republic of
      • Busan, Korea, Republic of, 49241
        • Investigative Site 82004
      • Seongnam-si, Gyeonggi-do, Korea, Republic of, 13496
        • Investigative Site 82003
      • Seoul, Korea, Republic of, 3080
        • Investigative Site 82001
      • Seoul, Korea, Republic of, 3722
        • Investigative Site 82005
      • Seoul, Korea, Republic of, 5505
        • Investigative Site 82002
  • New Zealand
      • Auckland, New Zealand, 2025
        • Investigative Site 64001
    • Dunedin
      • Dunedin Central, Dunedin, New Zealand, 9016
        • Investigative Site 64002
  • Singapore
      • Singapore, Singapore, 169608
        • Investigative Site 65001
      • Singapore, Singapore, 529889
        • Investigative Site 65002
  • Thailand
      • Bangkok, Thailand, 10330
        • Investigative Site 66001
      • Chiang Mai, Thailand, 50200
        • Investigative Site 66003
      • Khon Kaen, Thailand, 40002
        • Investigative Site 66002
      • Nonthaburi, Thailand, 11000
        • Investigative Site 66005
      • Nonthaburi, Thailand, 11000
        • Investigative Site 66006
      • Pathumthani, Thailand, 12120
        • Investigative Site 66004
      • Songkhla, Thailand, 90110
        • Investigative Site 66007

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cohort A
Participants will receive BRII-835 (VIR-2218) for 32 weeks
Drug: BRII-835 (VIR-2218)
BRII-835 (VIR-2218) will be given by subcutaneous injection
Experimental: Cohort B
Participants will receive BRII-835 (VIR-2218) and BRII-179 (VBI-2601) with IFN-α up to Week 40
Drug: BRII-835 (VIR-2218)
BRII-835 (VIR-2218) will be given by subcutaneous injection
Biological: BRII-179 (VBI-2601) with IFN-α
BRII-179 (VBI-2601) with IFN-α will be co-administered by intramuscular injection
Experimental: Cohort C
Participant will receive BRII-835 (VIR-2218) and BRII-179 (VBI-2601) up to Week 40
Drug: BRII-835 (VIR-2218)
BRII-835 (VIR-2218) will be given by subcutaneous injection
Biological: BRII-179 (VBI-2601)
BRII-179 (VBI-2601) will be administered by intramuscular injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Percentage of participants with sustained HBsAg loss during the 48-week follow-up period after NrtI withdrawal
Time Frame: up to Week 96
up to Week 96
Number of participants with Adverse Events (AE)
Time Frame: up to Week 96
up to Week 96
Number of participants with Serious Adverse Events (SAE)
Time Frame: up to Week 96
up to Week 96
Number of participants with abnormalities in clinical laboratory tests
Time Frame: up to Week 96
up to Week 96

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Brii Biosciences Limited

Collaborators

VBI Vaccines Inc.
Vir Biotechnology, Inc.

Investigators

  • Study Director: Xiaofei Chen, Brii Biosciences Limited

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 12, 2021

Primary Completion (Actual)

July 4, 2023

Study Completion (Actual)

July 4, 2023

Study Registration Dates

First Submitted

February 7, 2021

First Submitted That Met QC Criteria

February 7, 2021

First Posted (Actual)

February 11, 2021

Study Record Updates

Last Update Posted (Actual)

October 11, 2023

Last Update Submitted That Met QC Criteria

October 9, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BRII-179-835-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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