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

NCT ID: NCT04412863

Last Updated: 2024-09-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

84 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-07-03

Study Completion Date

2024-03-25

Brief Summary

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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.

Detailed Description

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Conditions

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Chronic Hepatitis B

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Cohort 1d

VIR-2218 given by subcutaneous injection

Group Type EXPERIMENTAL

VIR-2218

Intervention Type DRUG

VIR-2218 given by subcutaneous injection

Cohort 2d

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

Group Type EXPERIMENTAL

VIR-2218

Intervention Type DRUG

VIR-2218 given by subcutaneous injection

pegylated interferon-alfa 2a

Intervention Type DRUG

pegylated interferon-alfa 2a given by subcutaneous injection

Cohort 3d

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

Group Type EXPERIMENTAL

VIR-2218

Intervention Type DRUG

VIR-2218 given by subcutaneous injection

pegylated interferon-alfa 2a

Intervention Type DRUG

pegylated interferon-alfa 2a given by subcutaneous injection

Cohort 1e

VIR-2218 given by subcutaneous injection

Group Type EXPERIMENTAL

VIR-2218

Intervention Type DRUG

VIR-2218 given by subcutaneous injection

Cohort 2e

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

Group Type EXPERIMENTAL

VIR-2218

Intervention Type DRUG

VIR-2218 given by subcutaneous injection

pegylated interferon-alfa 2a

Intervention Type DRUG

pegylated interferon-alfa 2a given by subcutaneous injection

Cohort 3e

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

Group Type EXPERIMENTAL

VIR-2218

Intervention Type DRUG

VIR-2218 given by subcutaneous injection

pegylated interferon-alfa 2a

Intervention Type DRUG

pegylated interferon-alfa 2a given by subcutaneous injection

Cohort 1f

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

Group Type EXPERIMENTAL

VIR-2218

Intervention Type DRUG

VIR-2218 given by subcutaneous injection

pegylated interferon-alfa 2a

Intervention Type DRUG

pegylated interferon-alfa 2a given by subcutaneous injection

Cohort 2f

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

Group Type EXPERIMENTAL

VIR-2218

Intervention Type DRUG

VIR-2218 given by subcutaneous injection

pegylated interferon-alfa 2a

Intervention Type DRUG

pegylated interferon-alfa 2a given by subcutaneous injection

Cohort 3f

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

Group Type EXPERIMENTAL

VIR-2218

Intervention Type DRUG

VIR-2218 given by subcutaneous injection

pegylated interferon-alfa 2a

Intervention Type DRUG

pegylated interferon-alfa 2a given by subcutaneous injection

Interventions

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VIR-2218

VIR-2218 given by subcutaneous injection

Intervention Type DRUG

pegylated interferon-alfa 2a

pegylated interferon-alfa 2a given by subcutaneous injection

Intervention Type DRUG

Other Intervention Names

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pegylated interferon alpha-2a PEG-IFNα

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Alnylam Pharmaceuticals

INDUSTRY

Sponsor Role collaborator

Vir Biotechnology, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Investigative Site

Birtinya, Queensland, Australia

Site Status

Investigative Site

Fitzroy, Victoria, Australia

Site Status

Investigative site

Hong Kong, , Hong Kong

Site Status

Investigative Site

Batu Caves, , Malaysia

Site Status

Investigative Site

Kajang, , Malaysia

Site Status

Investigative Site

Kuala Lumpur, , Malaysia

Site Status

Investigative Site

Kuantan, , Malaysia

Site Status

Investigative Site

Auckland, , New Zealand

Site Status

Investigative Site

Auckland, , New Zealand

Site Status

Investigative Site

Busan, , South Korea

Site Status

Investigative Site

Chuncheon, , South Korea

Site Status

Investigative Site

Daegu, , South Korea

Site Status

Investigative Site

Seoul, , South Korea

Site Status

Investigative Site

Seoul, , South Korea

Site Status

Investigative Site

Yangsan, , South Korea

Site Status

Investigative Site

Bangkok, , Thailand

Site Status

Investigative Site

Bangkok, , Thailand

Site Status

Investigative Site

Bangkok, , Thailand

Site Status

Investigative Site

Chiang Mai, , Thailand

Site Status

Investigative Site

Hat Yai, , Thailand

Site Status

Investigative Site

Khlong Luang, , Thailand

Site Status

Investigative Site

Khon Kaen, , Thailand

Site Status

Countries

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Australia Hong Kong Malaysia New Zealand South Korea Thailand

Other Identifiers

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VIR-2218-1001-PEG-IFNα

Identifier Type: -

Identifier Source: org_study_id

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