Study of VIR-2218, VIR-3434, And/or PEG-IFNα in Subjects with Chronic Hepatitis B Virus Infection (MARCH)

Vir Biotechnology

Status and phase: Active, not recruiting; Phase 2

Conditions: Hepatitis B, Chronic

Treatments: Drug: VIR-2218; Drug: PEG-IFNα; Drug: VIR-3434

Study type: Interventional

Funder types: Industry

Identifiers

NCT04856085

VIR-2218-1006

Details and patient eligibility

About

This is a phase 2 study in which participants with chronic hepatitis B virus (HBV) infection will receive VIR-2218, VIR-3434 and/or PEG-IFNα and be assessed for safety, tolerability, and efficacy

Enrollment: 244 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male or female ages 18 - <66 years
• Chronic HBV infection for >/= 6 months
• On NRTI therapy for >/= 2 months at the time of screening

Exclusion criteria

• Any clinically significant chronic or acute medical condition that makes the participant unsuitable for participation
• Significant fibrosis or cirrhosis
• History or evidence of drug or alcohol abuse
• History of chronic liver disease from any cause other than chronic HBV infection
• History of hepatic decompensation
• History of anaphylaxis
• History of allergic reactions, hypersensitivity, or intolerance to monoclonal antibodies, antibody fragments, or any excipients of VIR-3434
• History of immune complex disease
• History of known contraindication to any interferon product

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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244 participants in 13 patient groups

Cohort 1a (VIR-2218 + VIR-3434)

Experimental group

Description:

Participants will receive multiple lead-in doses of VIR-2218, then combination therapy with VIR-2218 + VIR-3434 for 20 weeks total

Treatment:

Drug: VIR-3434

Drug: VIR-2218

Cohort 2a (VIR-2218 + VIR-3434)

Experimental group

Description:

Participants will receive multiple lead-in doses of VIR-2218, then combination therapy with VIR-2218 + VIR-3434 for 20 weeks total

Treatment:

Drug: VIR-3434

Drug: VIR-2218

Cohort 3a (VIR-2218 + VIR-3434)

Experimental group

Description:

Participants will receive multiple doses of VIR-2218 + VIR-3434 for 4 weeks

Treatment:

Drug: VIR-3434

Drug: VIR-2218

Cohort 4a (VIR-2218 + VIR-3434)

Experimental group

Description:

Participants will receive multiple doses of VIR-2218 + VIR-3434 for 4 weeks

Treatment:

Drug: VIR-3434

Drug: VIR-2218

Cohort 5a (VIR-2218 + VIR-3434)

Experimental group

Description:

Participants will receive multiple doses of VIR-2218 + VIR-3434 for 11 weeks

Treatment:

Drug: VIR-3434

Drug: VIR-2218

Cohort 6a (VIR-2218 + VIR-3434)

Experimental group

Description:

Participants will receive multiple doses of VIR-2218 + VIR-3434 for 11 weeks

Treatment:

Drug: VIR-3434

Drug: VIR-2218

Cohort 7a (VIR-2218 + VIR-3434)

Experimental group

Description:

Participants will receive multiple doses of VIR-2218 + VIR-3434 for 44 weeks

Treatment:

Drug: VIR-3434

Drug: VIR-2218

Cohort 8a (VIR-2218 + VIR-3434)

Experimental group

Description:

Participants will receive multiple doses of VIR-2218 + VIR-3434 for 20 weeks

Treatment:

Drug: VIR-3434

Drug: VIR-2218

Cohort 1b (VIR-3434)

Experimental group

Description:

Participants will receive multiple doses of VIR-3434 for 44 weeks

Treatment:

Drug: VIR-3434

Cohort 2b (VIR-3434)

Experimental group

Description:

Participants will receive multiple doses of VIR-3434 for 20 weeks

Treatment:

Drug: VIR-3434

Cohort 1c (VIR-2218 + VIR-3434 + PEG-IFNα)

Experimental group

Description:

Participants will receive multiple doses of VIR-2218 + VIR-3434 + PEG-IFNα for 24 weeks

Treatment:

Drug: VIR-3434

Drug: PEG-IFNα

Drug: VIR-2218

Cohort 2c (VIR-2218 + VIR-3434 + PEG-IFNα)

Experimental group

Description:

Participants will receive multiple doses of VIR-2218 + VIR-3434 + PEG-IFNα for 48 weeks

Treatment:

Drug: VIR-3434

Drug: PEG-IFNα

Drug: VIR-2218

Cohort 1d (VIR-3434 + PEG-IFNα)

Experimental group

Description:

Participants will receive multiple doses of VIR-3434 + PEG-IFNα for 48 weeks

Treatment:

Drug: VIR-3434

Drug: PEG-IFNα