Study of VIR-2218 With or Without Pegylated Interferon Alpha-2a for Treatment of Chronic Hepatitis B Virus Infection

Study Overview
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Brief Summary
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This is a phase 2 study in which subjects with chronic hepatitis B virus (HBV) infection will receive VIR-2218 alone or in combination with pegylated interferon alfa-2a and will be assessed for safety, tolerability, pharmacokinetics, and antiviral activity.

Official Title
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A Phase 1/2 Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Antiviral Activity of VIR-2218 Alone or in Combination With Pegylated Interferon Alpha-2a

Conditions
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Chronic Hepatitis B

Intervention / Treatment
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* Drug: VIR-2218
* Drug: pegylated interferon-alfa 2a


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female of ages 18 - 65 Chronic HBV infection 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 injection History of chronic liver disease from any cause other than chronic HBV infection History of hepatic decompensation Any prior receipt of an interferon product

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 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: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cohort 1d<br>VIR-2218 given by subcutaneous injection | Drug: VIR-2218<br>* VIR-2218 given by subcutaneous injection<br>|
| Experimental: Cohort 2d<br>VIR-2218 and pegylated interferon-alfa 2a given by subcutaneous injection | Drug: VIR-2218<br>* VIR-2218 given by subcutaneous injection<br>Drug: pegylated interferon-alfa 2a<br>* pegylated interferon-alfa 2a given by subcutaneous injection<br>* Other names: PEG-IFNα;|
| Experimental: Cohort 3d<br>VIR-2218 and pegylated interferon-alfa 2a given by subcutaneous injection | Drug: VIR-2218<br>* VIR-2218 given by subcutaneous injection<br>Drug: pegylated interferon-alfa 2a<br>* pegylated interferon-alfa 2a given by subcutaneous injection<br>* Other names: PEG-IFNα;|
| Experimental: Cohort 1e<br>VIR-2218 given by subcutaneous injection | Drug: VIR-2218<br>* VIR-2218 given by subcutaneous injection<br>|
| Experimental: Cohort 2e<br>VIR-2218 and pegylated interferon-alfa 2a given by subcutaneous injection | Drug: VIR-2218<br>* VIR-2218 given by subcutaneous injection<br>Drug: pegylated interferon-alfa 2a<br>* pegylated interferon-alfa 2a given by subcutaneous injection<br>* Other names: PEG-IFNα;|
| Experimental: Cohort 3e<br>VIR-2218 and pegylated interferon-alfa 2a given by subcutaneous injection | Drug: VIR-2218<br>* VIR-2218 given by subcutaneous injection<br>Drug: pegylated interferon-alfa 2a<br>* pegylated interferon-alfa 2a given by subcutaneous injection<br>* Other names: PEG-IFNα;|
| Experimental: Cohort 1f<br>VIR-2218 and pegylated interferon-alfa 2a given by subcutaneous injection | Drug: VIR-2218<br>* VIR-2218 given by subcutaneous injection<br>Drug: pegylated interferon-alfa 2a<br>* pegylated interferon-alfa 2a given by subcutaneous injection<br>* Other names: PEG-IFNα;|
| Experimental: Cohort 2f<br>VIR-2218 and pegylated interferon-alfa 2a given by subcutaneous injection | Drug: VIR-2218<br>* VIR-2218 given by subcutaneous injection<br>Drug: pegylated interferon-alfa 2a<br>* pegylated interferon-alfa 2a given by subcutaneous injection<br>* Other names: PEG-IFNα;|
| Experimental: Cohort 3f<br>VIR-2218 and pegylated interferon-alfa 2a given by subcutaneous injection | Drug: VIR-2218<br>* VIR-2218 given by subcutaneous injection<br>Drug: pegylated interferon-alfa 2a<br>* pegylated interferon-alfa 2a given by subcutaneous injection<br>* Other names: PEG-IFNα;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of subjects with Adverse Events as assessed by CTCAE v5.0 |  | Up to 148 Weeks | 
| Number of subjects with abnormalities in vital signs, electrocardiogram (ECG), and clinically significant laboratory findings |  | Up to 148 Weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean maximum reduction of serum HBsAg at any timepoint |  | Up to 144 Weeks | 
| Number of subjects with serum HBsAg loss (undetectable HBsAg) at any timepoint |  | Up to 144 Weeks | 
| Number of subjects with sustained serum HBsAg loss (undetectable HBsAg) for greater than 6 months |  | Up to 144 Weeks | 
| Number of subjects with anti-HBs seroconversion at any timepoint |  | Up to 144 Weeks | 
| For HBeAg-positive subjects: number of subjects with HBeAg loss (undetectable HBeAg) and/or anti-HBe seroconversion at any timepoint |  | Up to 96 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hepatitis B Virus, Chronic Hepatitis B, HBV, Hepatitis