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

Phase 2

Active, not recruiting

• Conditions: Chronic Hepatitis B Virus Infection
• Interventions: Biological: PEG-IFNα; Drug: BRII-835

• Registration Number: NCT05970289
• Lead Sponsor: Brii Biosciences Limited

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-07-21
• Study First Submitted QC: 2023-07-21
• Study First Posted: 2023-08-01
• Study Start: 2023-08-22
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-20
• Last Update Posted: 2024-03-21
• Primary Completion: 2025-08
• Study Completion: 2026-02

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 75

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cohort 3	BRII-835	Participants will receive multiple doses of lower dose level of BRII-835 + PEG-IFNα for 48 weeks.
Cohort 4	BRII-835	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).
Cohort 2	PEG-IFNα	Participants will receive multiple doses of higher dose level of BRII-835 + PEG-IFNα for 48 weeks.
Cohort 1	PEG-IFNα	Participants will receive multiple doses of PEG-IFNα for 48 weeks.
Cohort 2	BRII-835	Participants will receive multiple doses of higher dose level of BRII-835 + PEG-IFNα for 48 weeks.
Cohort 3	PEG-IFNα	Participants will receive multiple doses of lower dose level of BRII-835 + PEG-IFNα for 48 weeks.
Cohort 4	PEG-IFNα	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).

Primary Outcome Measures

Name	Time	Method
Proportion of participants with HBsAg loss at 24 weeks post-end of treatment	Up to Week 72
Proportion of participants with HBsAg loss at end of treatment	Up to Week 48
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 Locations

Locations (28)

nvestigative Site 66007; 🇹🇭 Chiang Mai, Thailand

Investigative Site 61003; 🇦🇺 Melbourne, Victoria, Australia

Investigative Site 61001; 🇦🇺 Kingswood, New South Wales, Australia

Investigative Site 88602; 🇨🇳 Taipei, Taiwan, China

Investigative Site 66008; 🇹🇭 Songkhla, Thailand

Investigative Site 82002; 🇰🇷 Chuncheon-si, Korea, Republic of

Investigative Site 66006; 🇹🇭 Nonthaburi, Thailand

Investigative Site 86004; 🇨🇳 Chongqing, Chongqing, China

Investigative Site 86001; 🇨🇳 Beijing, Beijing, China

Investigative Site 86007; 🇨🇳 Beijing, Beijing, China

Investigative Site 85201; 🇨🇳 Hong Kong, Hong Kong, China

Investigative Site 85202; 🇨🇳 Hong Kong, Hong Kong, China

Investigative Site 86006; 🇨🇳 Guangzhou, Guangdong, China

Investigative Site 86008; 🇨🇳 Changchun, Jilin, China

Investigative Site 88601; 🇨🇳 Kaohsiung, Taiwan, China

Investigative Site 86013; 🇨🇳 Shanghai, Shanghai, China

Investigative Site 88603; 🇨🇳 Taipei, Taiwan, China

Investigative Site 86011; 🇨🇳 Hangzhou, Zhengjiang, China

Investigative Site 61002; 🇦🇺 Birtinya, Queensland, Australia

Investigative Site 82001; 🇰🇷 Busan, Korea, Republic of

Investigative Site 82004; 🇰🇷 Daegu, Korea, Republic of

Investigative Site 82005; 🇰🇷 Seoul, Korea, Republic of

Investigative Site 82003; 🇰🇷 Seoul, Korea, Republic of

Investigative Site 65001; 🇸🇬 Singapore, Singapore

Investigative Site 82006; 🇰🇷 Soeul, Korea, Republic of

Investigative Site 65002; 🇸🇬 Singapore, Singapore

Investigative Site 66003; 🇹🇭 Bangkok, Thailand

Investigative Site 66005; 🇹🇭 Khon Kaen, Thailand