Clinical trial

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

Name

VIR-2218-1001-PEG-IFNα

Description

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.

Trial arms

Trial start

2020-07-03

Estimated PCD

2024-03-25

Trial end

2024-11-01

Status

Active (not recruiting)

Phase

Early phase I

Treatment

VIR-2218

VIR-2218 given by subcutaneous injection

Arms:

Cohort 1d, Cohort 1e, Cohort 1f, Cohort 2d, Cohort 2e, Cohort 2f, Cohort 3d, Cohort 3e, Cohort 3f

pegylated interferon-alfa 2a

pegylated interferon-alfa 2a given by subcutaneous injection

Arms:

Cohort 1f, Cohort 2d, Cohort 2e, Cohort 2f, Cohort 3d, Cohort 3e, Cohort 3f

Other names:

pegylated interferon alpha-2a, PEG-IFNα

Size

Primary endpoint

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

Eligibility criteria

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

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'NON_RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 84, 'type': 'ACTUAL'}}

Updated at

2024-05-03

1 organization

2 products

1 indication

Organization

Vir Biotechnology

Product

VIR-2218

Indication

Chronic Hepatitis B

Product

Pegylated Interferon-alfa 2a