Study to Investigate the Efficacy and Safety of Regimens Containing BRII-179, BRII-835, and PEG-IFNα Treating Chronic Hepatitis B Virus (HBV) Infection (ENRICH)

Last updated: December 26, 2024
Sponsor: Brii Biosciences Limited
Overall Status: Active - Not Recruiting

Phase

2

Condition

Hepatitis B

Hepatitis

Liver Disorders

Treatment

PEG-IFNα

BRII-179

BRII-835 (VIR-2218)

Clinical Study ID

NCT06491563
BRII-179-835-002
  • Ages 18-60
  • All Genders

Study Summary

This study will evaluate the efficacy and safety of the regimens containing BRII-179, BRII-835, and PEG-IFNα in adult participants with chronic hepatitis B virus (HBV) infection receiving nucleos(t)ide reverse transcriptase inhibitors (NRTIs) as background therapy.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Male or female aged 18-60 years.
  1. Body mass index ≥ 18 kg/m2 and ≤ 32 kg/m2.
  1. Chronic HBV infection for ≥ 6 months.
  1. On NRTI therapy for ≥ 6 months.

Exclusion

Exclusion Criteria:

  1. Any clinically significant chronic or acute medical condition that makes theparticipant unsuitable for participation.
  1. Significant liver fibrosis or cirrhosis.
  1. History or evidence of drug or alcohol abuse.
  1. History of intolerance to SC or IM injection.
  1. History of chronic liver disease from any cause other than chronic HBVinfection.
  1. History of hepatic decompensation.
  1. Contraindications to the use of PEG-IFNα.

Study Design

Total Participants: 150
Treatment Group(s): 3
Primary Treatment: PEG-IFNα
Phase: 2
Study Start date:
August 06, 2024
Estimated Completion Date:
June 30, 2027

Connect with a study center

  • Investigative Site 86004

    Beijing, Beijing 100000
    China

    Site Not Available

  • Investigative Site 86009

    Beijing, Beijing 100000
    China

    Site Not Available

  • Investigative Site 86006

    Chongqing, Chongqing 400000
    China

    Site Not Available

  • Investigative Site 86015

    Xiamen, Fujian 361000
    China

    Site Not Available

  • Investigative Site 86012

    Foshan, Guangdong 528000
    China

    Site Not Available

  • Investigative Site 86001

    Guangzhou, Guangdong 510000
    China

    Site Not Available

  • Investigative Site 86013

    Guangzhou, Guangdong 510000
    China

    Site Not Available

  • Investigative Site 86002

    Shenzhen, Guangdong 518000
    China

    Site Not Available

  • Investigative Site 86010

    Wuhan, Hubei 430000
    China

    Site Not Available

  • Investigative Site 86003

    Shanghai, Shanghai 200000
    China

    Site Not Available

  • Investigative Site 86008

    Shanghai, Shanghai 200000
    China

    Site Not Available

  • Investigative Site 86007

    Chengdu, Sichuan 610000
    China

    Site Not Available

  • Investigative Site 86011

    Chengdu, Sichuan 610000
    China

    Site Not Available

  • Investigative Site 86014

    Chengdu, Sichuan 610000
    China

    Site Not Available

  • Investigative Site 86005

    Hangzhou, Zhejiang 310000
    China

    Site Not Available

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