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

June 16, 2024 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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
91

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Brii Biosciences Limited

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
VBI Vaccines Inc.
Vir Biotechnology, Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 12, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 4, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 4, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 7, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 7, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 11, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 18, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 16, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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Locations

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