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

Last updated: March 20, 2024
Sponsor: Brii Biosciences Limited
Overall Status: Active - Not Recruiting

Phase

2

Condition

Hepatitis B

Hepatitis

Treatment

PEG-IFNα

BRII-835

Clinical Study ID

NCT05970289
BRII-835-002
  • Ages 18-60
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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

Exclusion Criteria:

  • Any clinically significant chronic or acute medical condition that makes theparticipant 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 Design

Total Participants: 75
Treatment Group(s): 2
Primary Treatment: PEG-IFNα
Phase: 2
Study Start date:
August 22, 2023
Estimated Completion Date:
February 28, 2026

Connect with a study center

  • Investigative Site 61001

    Kingswood, New South Wales 2747
    Australia

    Site Not Available

  • Investigative Site 61002

    Birtinya, Queensland 4575
    Australia

    Site Not Available

  • Investigative Site 61003

    Melbourne, Victoria 3004
    Australia

    Site Not Available

  • Investigative Site 86001

    Beijing, Beijing 100000
    China

    Site Not Available

  • Investigative Site 86002

    Beijing, Beijing 100015
    China

    Site Not Available

  • Investigative Site 86007

    Beijing, Beijing 100069
    China

    Site Not Available

  • Investigative Site 86004

    Chongqing, Chongqing 400010
    China

    Site Not Available

  • Investigative Site 86006

    Guangzhou, Guangdong 510630
    China

    Site Not Available

  • Investigative Site 86014

    Guangzhou, Guangdong 510515
    China

    Site Not Available

  • Investigative Site 86016

    Shenzhen, Guangdong 518112
    China

    Site Not Available

  • Investigative Site 85201

    Hong Kong, Hong Kong 999077
    China

    Site Not Available

  • Investigative Site 85202

    Hong Kong, Hong Kong 999077
    China

    Site Not Available

  • Investigative Site 85203

    Kowloon, Hong Kong 999077
    China

    Site Not Available

  • Investigative Site 85204

    NEW Territories, Hong Kong 999077
    China

    Site Not Available

  • Investigative Site 86008

    Changchun, Jilin 130021
    China

    Site Not Available

  • Investigative Site 86005

    Shanghai, Shanghai 200040
    China

    Site Not Available

  • Investigative Site 86013

    Shanghai, Shanghai 200025
    China

    Site Not Available

  • Investigative Site 86003

    Chendu, Sichuan 610041
    China

    Site Not Available

  • Investigative Site 86009

    Chengdu, Sichuan 610500
    China

    Site Not Available

  • Investigative Site 88601

    Kaohsiung, Taiwan 80756
    China

    Site Not Available

  • Investigative Site 88602

    Taipei, Taiwan 10041
    China

    Site Not Available

  • Investigative Site 88603

    Taipei, Taiwan 11217
    China

    Site Not Available

  • Investigative Site 88604

    Taoyuan, Taiwan 333
    China

    Site Not Available

  • Investigative Site 86010

    Kunming, Yunnan 650032
    China

    Site Not Available

  • Investigative Site 86011

    Hangzhou, Zhengjiang 310016
    China

    Site Not Available

  • Investigative Site 82001

    Busan, 49241
    Korea, Republic of

    Site Not Available

  • Investigative Site 82002

    Chuncheon-si, 24253
    Korea, Republic of

    Site Not Available

  • Investigative Site 82004

    Daegu, 41566
    Korea, Republic of

    Site Not Available

  • Investigative Site 82003

    Seoul, 6351
    Korea, Republic of

    Site Not Available

  • Investigative Site 82005

    Seoul, 13496
    Korea, Republic of

    Site Not Available

  • Investigative Site 82006

    Soeul, 05505
    Korea, Republic of

    Site Not Available

  • Investigative Site 60005

    Johor Bahru, Johor 80100
    Malaysia

    Site Not Available

  • Investigative Site 60001

    Sabah, KOTA Kinabalu 88586
    Malaysia

    Site Not Available

  • Investigative Site 60003

    Kuala Lumpur, Kuala LUMP 59000
    Malaysia

    Site Not Available

  • Investigative Site 60004

    Kuala Lumpur, WP 59100
    Malaysia

    Site Not Available

  • Investigative Site 60002

    Melaka, 59000
    Malaysia

    Site Not Available

  • Investigative Site 65001

    Singapore, 169856
    Singapore

    Site Not Available

  • Investigative Site 65002

    Singapore, 529889
    Singapore

    Site Not Available

  • Investigative Site 66002

    Bangkok, 10400
    Thailand

    Site Not Available

  • Investigative Site 66003

    Bangkok, 10330
    Thailand

    Site Not Available

  • Investigative Site 66004

    Bangkok, 10400
    Thailand

    Site Not Available

  • nvestigative Site 66007

    Chiang Mai, 50200
    Thailand

    Site Not Available

  • Investigative Site 66005

    Khon Kaen, 40002
    Thailand

    Site Not Available

  • Investigative Site 66001

    Nonthaburi, 11000
    Thailand

    Site Not Available

  • Investigative Site 66006

    Nonthaburi, 11000
    Thailand

    Site Not Available

  • Investigative Site 66008

    Songkhla, 90110
    Thailand

    Site Not Available

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.