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

Study Overview
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Brief Summary
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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.

Official Title
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A Phase 2 Multicenter, Randomized, Open-label Study to Investigate the Efficacy and Safety of BRII-835 (VIR-2218) and Pegylated Interferon Alpha (PEG-IFNα) Combination Therapy for the Treatment of Chronic Hepatitis B Virus (HBV) Infection

Conditions
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Chronic Hepatitis B Virus Infection

Intervention / Treatment
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* Biological: PEG-IFNα
* Drug: BRII-835


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cohort 1<br>Participants will receive multiple doses of PEG-IFNα for 48 weeks. | Biological: PEG-IFNα<br>* PEG-IFNα will be given via subcutaneous injection<br>* Other names: pegylated interferon alfa;|
| Experimental: Cohort 2<br>Participants will receive multiple doses of higher dose level of BRII-835 + PEG-IFNα for 48 weeks. | Biological: PEG-IFNα<br>* PEG-IFNα will be given via subcutaneous injection<br>* Other names: pegylated interferon alfa;Drug: BRII-835<br>* BRII-835 will be given via subcutaneous injection<br>|
| Experimental: Cohort 3<br>Participants will receive multiple doses of lower dose level of BRII-835 + PEG-IFNα for 48 weeks. | Biological: PEG-IFNα<br>* PEG-IFNα will be given via subcutaneous injection<br>* Other names: pegylated interferon alfa;Drug: BRII-835<br>* BRII-835 will be given via subcutaneous injection<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |