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

NCT05970289 · tracked via the Priya Life Science Australia tracker

Sponsor

Brii Biosciences Limited

Phase

Phase 2

Started

2023-08-22

Last updated

2025-09-05

Condition(s) studied

Chronic Hepatitis B Virus Infection

Investigational drug(s) / intervention(s)

PEG-IFNα →BRII-835 →

PEG-IFNα: PEG-IFNα will be given via subcutaneous injection

BRII-835: BRII-835 will be given via subcutaneous injection

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

Sex

ALL

Min age

18 Years

Max age

60 Years

Healthy volunteers

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.

Primary outcome measure(s)

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

Trial sites (29)

Facility	City	Region
Investigative Site 61001	Kingswood	New South Wales
Investigative Site 61002	Birtinya	Queensland
Investigative Site 61003	Melbourne	Victoria
Investigative Site 86001	Beijing	Beijing Municipality
Investigative Site 86001	Beijing	Beijing Municipality
Investigative Site 86007	Beijing	Beijing Municipality
Investigative Site 86004	Chongqing	Chongqing Municipality
Investigative Site 86006	Guangzhou	Guangdong
Investigative Site 85201	Hong Kong	HONG KONG
Investigative Site 85202	Hong Kong	HONG KONG
Investigative Site 86008	Changchun	Jilin
Investigative Site 86013	Shanghai	Shanghai Municipality
Investigative Site 88601	Kaohsiung	Taiwan
Investigative Site 88602	Taipei	Taiwan
Investigative Site 88603	Taipei	Taiwan
Investigative Site 86011	Hangzhou	Zhengjiang
Investigative Site 65001	Singapore	Singapore
Investigative Site 65002	Singapore	Singapore
Investigative Site 82002	Chuncheon	Chuncheon-si
Investigative Site 82001	Busan	South Korea
Investigative Site 82004	Daegu	South Korea
Investigative Site 82005	Seoul	South Korea
Investigative Site 82003	Seoul	South Korea
Investigative Site 82006	Soeul	South Korea
Investigative Site 66003	Bangkok	Thailand
nvestigative Site 66007	Chiang Mai	Thailand
Investigative Site 66005	Khon Kaen	Thailand
Investigative Site 66006	Nonthaburi	Thailand
Investigative Site 66008	Songkhla	Thailand

Other trials for the same condition

A Study of Sequential Therapy With Daplusiran/Tomligisiran (DAP/TOM) Followed by Bepirovirsen in Participants Living With Chronic Hepatitis B (CHB) Active, not recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05970289 on ClinicalTrials.gov ↗ ← All trials in Australia