Skip to main content
OpenTrials
Completed

NCT Number: NCT04412863

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Chronic Hepatitis B Blood-Borne Infections Chronic Disease Communicable Diseases DNA Virus Infections Digestive System Diseases Disease Attributes Hepadnaviridae Infections Hepatitis Hepatitis B Hepatitis B, Chronic Hepatitis, Chronic Hepatitis, Viral, Human Infections Liver Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Virus Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Investigative Site, Birtinya, Queensland, Australia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

VIR-2218

Drug

VIR-2218 given by subcutaneous injection

Other names: Elebsiran

pegylated interferon-alfa 2a

Drug

pegylated interferon-alfa 2a given by subcutaneous injection

Other names: pegylated interferon alpha-2a, PEG-IFNα

Primary outcomes

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

    Time frame: Up to 148 Weeks

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

    Time frame: Up to 148 Weeks

Secondary outcomes

  1. Mean Maximum Reduction of Serum HBsAg at Any Timepoint

    Time frame: Up to 148 Weeks

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

    Time frame: Up to 148 Weeks

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

    Time frame: Up to 148 Weeks

  4. Proportion of Subjects With Anti-HBs Seroconversion at Any Timepoint

    Time frame: Up to 148 Weeks

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

  5. 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

Sponsors and collaborators

Lead sponsor

Vir Biotechnology, Inc.

Industry

Collaborators

  • Alnylam Pharmaceuticals

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2024
Study completion
2024
First posted
Jun 2, 2020
Registry last updated
Apr 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.