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

Vir Biotechnology

Status and phase: Completed; Phase 2

Conditions: Chronic Hepatitis B

Treatments: Drug: pegylated interferon-alfa 2a; Drug: VIR-2218

Study type: Interventional

Funder types: Industry

Identifiers

NCT04412863

VIR-2218-1001-PEG-IFNα

Details and patient eligibility

About

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.

Enrollment: 84 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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84 participants in 9 patient groups

Cohort 1d

Experimental group

Description:

VIR-2218 given by subcutaneous injection

Treatment:

Drug: VIR-2218

Cohort 2d

Experimental group

Description:

VIR-2218 and pegylated interferon-alfa 2a given by subcutaneous injection

Treatment:

Drug: VIR-2218

Drug: pegylated interferon-alfa 2a

Cohort 3d

Experimental group

Description:

VIR-2218 and pegylated interferon-alfa 2a given by subcutaneous injection

Treatment:

Drug: VIR-2218

Drug: pegylated interferon-alfa 2a

Cohort 1e

Experimental group

Description:

VIR-2218 given by subcutaneous injection

Treatment:

Drug: VIR-2218

Cohort 2e

Experimental group

Description:

VIR-2218 and pegylated interferon-alfa 2a given by subcutaneous injection

Treatment:

Drug: VIR-2218

Drug: pegylated interferon-alfa 2a

Cohort 3e

Experimental group

Description:

VIR-2218 and pegylated interferon-alfa 2a given by subcutaneous injection

Treatment:

Drug: VIR-2218

Drug: pegylated interferon-alfa 2a

Cohort 1f

Experimental group

Description:

VIR-2218 and pegylated interferon-alfa 2a given by subcutaneous injection

Treatment:

Drug: VIR-2218

Drug: pegylated interferon-alfa 2a

Cohort 2f

Experimental group

Description:

VIR-2218 and pegylated interferon-alfa 2a given by subcutaneous injection

Treatment:

Drug: VIR-2218

Drug: pegylated interferon-alfa 2a

Cohort 3f

Experimental group

Description:

VIR-2218 and pegylated interferon-alfa 2a given by subcutaneous injection

Treatment:

Drug: VIR-2218

Drug: pegylated interferon-alfa 2a