A Phase 2 Multicenter, Randomized, Open-label Study to Investigate the Safety and Efficacy of BRII-835 (VIR-2218) and BRII-179 (VBI-2601) Combination Therapy for the Treatment of Chronic Hepatitis B Virus (HBV) Infection
Overview
- Phase
- Phase 2
- Intervention
- BRII-835 (VIR-2218)
- Conditions
- Hepatitis B, Chronic
- Sponsor
- Brii Biosciences Limited
- Enrollment
- 91
- Locations
- 28
- Primary Endpoint
- Percentage of participants with sustained HBsAg loss during the 48-week follow-up period after NrtI withdrawal
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
This is an open label, randomized, parallel-group study to evaluate the safety and efficacy of combination treatment BRII-835 (VIR-2218) and BRII-179 (VBI-2601) in adult participants with chronic HBV infection
Investigators
Eligibility Criteria
Inclusion Criteria
- •Male or female aged 18 - 60
- •Body mass index ≥ 18 kg/m\^2 and ≤ 32 kg/m\^2
- •Chronic HBV infection as defined by a positive serum HBsAg for ≥ 6 months
Exclusion Criteria
- •Any clinically significant chronic or acute medical condition that makes the volunteer unsuitable for participation
- •Significant fibrosis or cirrhosis
- •History or evidence of drug or alcohol abuse
- •History of intolerance to SC or IM injection
- •History of chronic liver disease from any cause other than chronic HBV infection
- •History of hepatic decompensation
Arms & Interventions
Cohort A
Participants will receive BRII-835 (VIR-2218) for 32 weeks
Intervention: BRII-835 (VIR-2218)
Cohort B
Participants will receive BRII-835 (VIR-2218) and BRII-179 (VBI-2601) with IFN-α up to Week 40
Intervention: BRII-835 (VIR-2218)
Cohort B
Participants will receive BRII-835 (VIR-2218) and BRII-179 (VBI-2601) with IFN-α up to Week 40
Intervention: BRII-179 (VBI-2601) with IFN-α
Cohort C
Participant will receive BRII-835 (VIR-2218) and BRII-179 (VBI-2601) up to Week 40
Intervention: BRII-835 (VIR-2218)
Cohort C
Participant will receive BRII-835 (VIR-2218) and BRII-179 (VBI-2601) up to Week 40
Intervention: BRII-179 (VBI-2601)
Outcomes
Primary Outcomes
Percentage of participants with sustained HBsAg loss during the 48-week follow-up period after NrtI withdrawal
Time Frame: up to Week 96
Number of participants with Serious Adverse Events (SAE)
Time Frame: up to Week 96
Number of participants with abnormalities in clinical laboratory tests
Time Frame: up to Week 96
Number of participants with Adverse Events (AE)
Time Frame: up to Week 96