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

Vir Biotechnology, Inc.84 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Chronic Hepatitis B

Interventions

VIR-2218DRUG

VIR-2218 given by subcutaneous injection

pegylated interferon-alfa 2aDRUG

pegylated interferon-alfa 2a given by subcutaneous injection

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Locations (22)

Investigative Site

Birtinya, Queensland, Australia

Investigative Site

Fitzroy, Victoria, Australia

Outcomes

Primary Outcomes

Number of Subjects With Adverse Events as Assessed by CTCAE v5.0

Time frame: Up to 148 Weeks

Number of Subjects With Abnormalities in Vital Signs, Electrocardiogram (ECG), and Clinically Significant Laboratory Findings

Time frame: Up to 148 Weeks

Secondary Outcomes

Mean Maximum Reduction of Serum HBsAg at Any Timepoint

Time frame: Up to 148 Weeks

Proportion of Subjects With Serum HBsAg Loss (Undetectable HBsAg) at Any Timepoint

Time frame: Up to 148 Weeks

Proportion of Subjects With Sustained Serum HBsAg Loss (Undetectable HBsAg) for Greater Than 6 Months

Time frame: Up to 148 Weeks

Proportion of Subjects With Anti-HBs Seroconversion at Any Timepoint

Anti-HBs seroconversion is defined as Anti-HBs quantitative value changed from baseline \<LLOQ (5 mIU/mL) to post-baseline\>=LLOQ.

Time frame: Up to 148 Weeks

For HBeAg-positive Patients: Proportion of Subjects With HBeAg Loss (Undetectable HBeAg) and/or Anti-HBe Seroconversion at Any Timepoint

Time frame: Up to 148 weeks

Data from ClinicalTrials.gov

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