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COMPLETEDPHASE2

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

NCT04412863•Vir Biotechnology, Inc.

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - 65 years

Sex

ALL

Healthy Volunteers

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

Investigative site

Hong Kong, Hong Kong

Investigative Site

Batu Caves, Malaysia

Investigative Site

Kajang, Malaysia

Investigative Site

Kuala Lumpur, Malaysia

Investigative Site

Kuantan, Malaysia

Investigative Site

Auckland, New Zealand

Investigative Site

Auckland, New Zealand

Investigative Site

Busan, South Korea

Key Dates

Start Date

July 3, 2020

Primary Completion Date

March 25, 2024

Completion Date

March 25, 2024

Last Updated

September 19, 2024

Enrollment

ACTUAL participants

Conditions

Chronic Hepatitis B

Interventions

VIR-2218

DRUG

pegylated interferon-alfa 2a

DRUG

Phase 1b, Open-label Study of Tune-401 to Assess Safety, PK and PD in Adults With Chronic Hepatitis B

NCT06671093

Chronic Hep BChronic Hepatitis b+2 more

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RECRUITINGPHASE1

HBV-Specific TCR-T Cell Therapy Combined With Nucleos(t)Ide Analogues in Chronic Hepatitis B Patients

NCT06885710

Chronic Hepatitis b

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 19, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Phase 1b, Open-label Study of Tune-401 to Assess Safety, PK and PD in Adults With Chronic Hepatitis B

HBV-Specific TCR-T Cell Therapy Combined With Nucleos(t)Ide Analogues in Chronic Hepatitis B Patients

A Randomized, Double-blind, Placebo-controlled Phase IIa Clinical Study to Evaluate the Safety and Efficacy of GST-HG131 Tablets in Patients With Chronic Hepatitis B

From Fungus to Virus, Investigating the Safety and Efficacy of Terbinafine in Chronic Hepatitis B Patients

Therapeutic Effects and Long-term Follow-up After Ending Nucleos(t)Ide Analogs Therapy in Chronic Hepatitis b

The Establishment of Korean Hepatitis B Patients Cohort