Study of VIR-2218 With or Without Pegylated Interferon Alpha-2a for Treatment of Chronic Hepatitis B Virus Infection
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
1 other identifier
interventional
84
6 countries
22
Brief Summary
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 Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Jul 2020
Typical duration for phase_2
22 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 29, 2020
CompletedFirst Posted
Study publicly available on registry
June 2, 2020
CompletedStudy Start
First participant enrolled
July 3, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 25, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
March 25, 2024
CompletedResults Posted
Study results publicly available
April 16, 2026
CompletedApril 16, 2026
March 1, 2026
3.7 years
May 29, 2020
March 25, 2025
March 27, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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
Secondary Outcomes (5)
Mean Maximum Reduction of Serum HBsAg at Any Timepoint
Up to 148 Weeks
Proportion of Subjects With Serum HBsAg Loss (Undetectable HBsAg) at Any Timepoint
Up to 148 Weeks
Proportion of Subjects With Sustained Serum HBsAg Loss (Undetectable HBsAg) for Greater Than 6 Months
Up to 148 Weeks
Proportion of Subjects With Anti-HBs Seroconversion at Any Timepoint
Up to 148 Weeks
For HBeAg-positive Patients: Proportion of Subjects With HBeAg Loss (Undetectable HBeAg) and/or Anti-HBe Seroconversion at Any Timepoint
Up to 148 weeks
Study Arms (9)
Cohort 1d
EXPERIMENTALVIR-2218 given by subcutaneous injection
Cohort 2d
EXPERIMENTALVIR-2218 and pegylated interferon-alfa 2a given by subcutaneous injection
Cohort 3d
EXPERIMENTALVIR-2218 and pegylated interferon-alfa 2a given by subcutaneous injection
Cohort 1e
EXPERIMENTALVIR-2218 given by subcutaneous injection
Cohort 2e
EXPERIMENTALVIR-2218 and pegylated interferon-alfa 2a given by subcutaneous injection
Cohort 3e
EXPERIMENTALVIR-2218 and pegylated interferon-alfa 2a given by subcutaneous injection
Cohort 1f
EXPERIMENTALVIR-2218 and pegylated interferon-alfa 2a given by subcutaneous injection
Cohort 2f
EXPERIMENTALVIR-2218 and pegylated interferon-alfa 2a given by subcutaneous injection
Cohort 3f
EXPERIMENTALVIR-2218 and pegylated interferon-alfa 2a given by subcutaneous injection
Interventions
VIR-2218 given by subcutaneous injection
pegylated interferon-alfa 2a given by subcutaneous injection
Eligibility Criteria
You may qualify if:
- Male or female of ages 18 - 65
- Chronic HBV infection for \>/= 6 months
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Vir Biotechnology, Inc.lead
- Alnylam Pharmaceuticalscollaborator
Study Sites (22)
Investigative Site
Birtinya, Queensland, 4575, Australia
Investigative Site
Fitzroy, Victoria, 3168, Australia
Investigative site
Hong Kong, Hong Kong
Investigative Site
Batu Caves, 68100, Malaysia
Investigative Site
Kajang, 43000, Malaysia
Investigative Site
Kuala Lumpur, 59100, Malaysia
Investigative Site
Kuantan, 25100, Malaysia
Investigative Site
Auckland, 1010, New Zealand
Investigative Site
Auckland, 2025, New Zealand
Investigative Site
Busan, 49241, South Korea
Investigative Site
Chuncheon, 24253, South Korea
Investigative Site
Daegu, 41944, South Korea
Investigative Site
Seoul, 03080, South Korea
Investigative Site
Seoul, 05505, South Korea
Investigative Site
Yangsan, 50612, South Korea
Investigative Site
Bangkok, 10330, Thailand
Investigative Site
Bangkok, 10400, Thailand
Investigative Site
Bangkok, 10700, Thailand
Investigative Site
Chiang Mai, 50200, Thailand
Investigative Site
Hat Yai, 90110, Thailand
Investigative Site
Khlong Luang, 12120, Thailand
Investigative Site
Khon Kaen, 40002, Thailand
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Study Inquiry
- Organization
- Vir Biotechnology, Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 29, 2020
First Posted
June 2, 2020
Study Start
July 3, 2020
Primary Completion
March 25, 2024
Study Completion
March 25, 2024
Last Updated
April 16, 2026
Results First Posted
April 16, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will not share