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

March 20, 2024 updated by: Brii Biosciences Limited

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

75

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 61001
    • Queensland
      • Birtinya, Queensland, Australia, 4575
        • Investigative Site 61002
    • Victoria
      • Melbourne, Victoria, Australia, 3004
        • Investigative Site 61003
  • China
    • Beijing
      • Beijing, Beijing, China, 100000
        • Investigative Site 86001
      • Beijing, Beijing, China, 100050
        • Investigative Site 86001
      • Beijing, Beijing, China, 100069
        • Investigative Site 86007
    • Chongqing
      • Chongqing, Chongqing, China, 400010
        • Investigative Site 86004
    • Guangdong
      • Guangzhou, Guangdong, China, 510630
        • Investigative Site 86006
    • Hong Kong
      • Hong Kong, Hong Kong, China, 999077
        • Investigative Site 85201
      • Hong Kong, Hong Kong, China, 999077
        • Investigative Site 85202
    • Jilin
      • Changchun, Jilin, China, 130021
        • Investigative Site 86008
    • Shanghai
      • Shanghai, Shanghai, China, 200025
        • Investigative Site 86013
    • Taiwan
      • Kaohsiung, Taiwan, China, 80756
        • Investigative Site 88601
      • Taipei, Taiwan, China, 10041
        • Investigative Site 88602
      • Taipei, Taiwan, China, 11217
        • Investigative Site 88603
    • Zhengjiang
      • Hangzhou, Zhengjiang, China, 310016
        • Investigative Site 86011
  • Korea, Republic of
      • Busan, Korea, Republic of, 49241
        • Investigative Site 82001
      • Chuncheon-si, Korea, Republic of, 24253
        • Investigative Site 82002
      • Daegu, Korea, Republic of, 41566
        • Investigative Site 82004
      • Seoul, Korea, Republic of, 6351
        • Investigative Site 82003
      • Seoul, Korea, Republic of, 13496
        • Investigative Site 82005
      • Soeul, Korea, Republic of, 05505
        • Investigative Site 82006
  • Singapore
      • Singapore, Singapore, 529889
        • Investigative Site 65002
      • Singapore, Singapore, 169856
        • Investigative Site 65001
  • Thailand
      • Bangkok, Thailand, 10330
        • Investigative Site 66003
      • Chiang Mai, Thailand, 50200
        • nvestigative Site 66007
      • Khon Kaen, Thailand, 40002
        • Investigative Site 66005
      • Nonthaburi, Thailand, 11000
        • Investigative Site 66006
      • Songkhla, Thailand, 90110
        • Investigative Site 66008

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

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

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 1
Participants will receive multiple doses of PEG-IFNα for 48 weeks.
Biological: PEG-IFNα
PEG-IFNα will be given via subcutaneous injection
Other Names:
  • pegylated interferon alfa
Experimental: Cohort 2
Participants will receive multiple doses of higher dose level of BRII-835 + PEG-IFNα for 48 weeks.
Biological: PEG-IFNα
PEG-IFNα will be given via subcutaneous injection
Other Names:
  • pegylated interferon alfa
Drug: BRII-835
BRII-835 will be given via subcutaneous injection
Experimental: Cohort 3
Participants will receive multiple doses of lower dose level of BRII-835 + PEG-IFNα for 48 weeks.
Biological: PEG-IFNα
PEG-IFNα will be given via subcutaneous injection
Other Names:
  • pegylated interferon alfa
Drug: BRII-835
BRII-835 will be given via subcutaneous injection
Experimental: Cohort 4
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
PEG-IFNα will be given via subcutaneous injection
Other Names:
  • pegylated interferon alfa
Drug: BRII-835
BRII-835 will be given via subcutaneous injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Proportion of participants with HBsAg loss at end of treatment
Time Frame: Up to Week 48
Up to Week 48
Proportion of participants with HBsAg loss at 24 weeks post-end of treatment
Time Frame: Up to Week 72
Up to Week 72
Proportion of participants with treatment-emergent adverse events (TEAEs)
Time Frame: Up to Week 72
Up to Week 72
Proportion of participants with serious adverse events (SAEs)
Time Frame: Up to Week 72
Up to Week 72

Collaborators and Investigators

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

Sponsor

Brii Biosciences Limited

Collaborators

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)

August 22, 2023

Primary Completion (Estimated)

August 1, 2025

Study Completion (Estimated)

February 1, 2026

Study Registration Dates

First Submitted

July 21, 2023

First Submitted That Met QC Criteria

July 21, 2023

First Posted (Actual)

August 1, 2023

Study Record Updates

Last Update Posted (Actual)

March 21, 2024

Last Update Submitted That Met QC Criteria

March 20, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BRII-835-002

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.

Clinical Trials on Chronic Hepatitis B Virus Infection

Clinical Trials on PEG-IFNα

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Türkiye

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe