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Clinical Trials in South Korea / NCT05970289
Active, not recruiting Phase 2

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 South Korea 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
No
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)

FacilityCityRegionStatus
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 South Korea