Clinical trial

A Phase 2 Study to Evaluate the Safety, Tolerability, and Efficacy of Regimens Containing VIR-2218, VIR-3434, and/or PEG-IFNα in Subjects With Chronic Hepatitis B Virus Infection

Name

VIR-2218-1006

Description

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

Trial arms

Trial start

2021-07-11

Estimated PCD

2027-06-01

Trial end

2027-06-01

Status

Recruiting

Phase

Early phase I

Treatment

VIR-2218

VIR-2218 given by subcutaneous injection

Arms:

Cohort 1a (VIR-2218 + VIR-3434), Cohort 1c (VIR-2218 + VIR-3434 + PEG-IFNα), Cohort 2a (VIR-2218 + VIR-3434), Cohort 2c (VIR-2218 + VIR-3434 + PEG-IFNα), Cohort 3a (VIR-2218 + VIR-3434), Cohort 4a (VIR-2218 + VIR-3434), Cohort 5a (VIR-2218 + VIR-3434), Cohort 6a (VIR-2218 + VIR-3434), Cohort 7a (VIR-2218 + VIR-3434), Cohort 8a (VIR-2218 + VIR-3434)

Other names:

Elebsiran

VIR-3434

VIR-3434 given by subcutaneous injection

Arms:

Cohort 1a (VIR-2218 + VIR-3434), Cohort 1b (VIR-3434), Cohort 1c (VIR-2218 + VIR-3434 + PEG-IFNα), Cohort 1d (VIR-3434 + PEG-IFNα), Cohort 2a (VIR-2218 + VIR-3434), Cohort 2b (VIR-3434), Cohort 2c (VIR-2218 + VIR-3434 + PEG-IFNα), Cohort 3a (VIR-2218 + VIR-3434), Cohort 4a (VIR-2218 + VIR-3434), Cohort 5a (VIR-2218 + VIR-3434), Cohort 6a (VIR-2218 + VIR-3434), Cohort 7a (VIR-2218 + VIR-3434), Cohort 8a (VIR-2218 + VIR-3434)

Other names:

Tobevibart

PEG-IFNα

PEG-IFNα given by subcutaneous injection

Arms:

Cohort 1c (VIR-2218 + VIR-3434 + PEG-IFNα), Cohort 1d (VIR-3434 + PEG-IFNα), Cohort 2c (VIR-2218 + VIR-3434 + PEG-IFNα)

Size

415

Primary endpoint

Proportion of participants with treatment-emergent adverse events (TEAEs)

Up to 110 weeks

Proportion of participants with serious adverse events (SAEs)

Up to 116 weeks

Proportion of participants with hepatitis B surface antigen (HBsAg) loss (defined as undetectable HBsAg) at end of treatment

Up to 48 weeks

Proportion of participants with HBsAg loss (defined as undetectable HBsAg) at 24 weeks post-end of treatment

Up to 72 weeks

Eligibility criteria

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

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'NON_RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 415, 'type': 'ESTIMATED'}}

Updated at

2024-04-24

1 organization

3 products

2 indications

Organization

Product

Indication

Indication

Product

Product