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 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 Locations

Locations (28)

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

Investigative Site 61002; 🇦🇺 Birtinya, Queensland, Australia

Investigative Site 61003; 🇦🇺 Melbourne, Victoria, Australia

Investigative Site 86001; 🇨🇳 Beijing, Beijing, China

Investigative Site 86007; 🇨🇳 Beijing, Beijing, China

Investigative Site 86004; 🇨🇳 Chongqing, Chongqing, China

Investigative Site 86006; 🇨🇳 Guangzhou, Guangdong, China

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

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

Investigative Site 86008; 🇨🇳 Changchun, Jilin, China

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