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A Platform Study to Evaluate Investigational Therapies in Chronic Hepatitis B Infection | Clinical Trials | Clareo Health

COMPLETEDPHASE1/PHASE2

A Platform Study to Evaluate Investigational Therapies in Chronic Hepatitis B Infection

A Platform Study Evaluating the Efficacy and Safety of Investigational Therapies in Participants With Chronic Hepatitis B Infection (PREVAIL)

NCT05612581•Vir Biotechnology, Inc.

View on ClinicalTrials.gov

Summary

This is a Phase 1b/2 platform study framework to evaluate the safety and efficacy of investigational candidate(s) and their combinations as potential treatments for adults with chronic hepatitis B virus infection.

Detailed Description

VIR-SHB1-V201 (STRIVE) Sub-Protocol A is a Phase 2 study under the PREVAIL platform trial. This is a multi-center, open-label study designed to evaluate the safety and efficacy of regimens containing VIR-3434, VIR-2218, PEGASYS (PEG-IFNα), and nucleotide reverse transcriptase inhibitors (NRTI) in noncirrhotic adult participants with chronic HBV infection that have not received prior NRTI or PEGASYS treatment. VIR-SHB1-V202 (THRIVE) Sub-Protocol B is a Phase 2 study under the PREVAIL platform trial. This is a multi-center open-label study designed to evaluate the safety and efficacy of regimens containing VIR-3434 and NRTI with or without VIR-2218 in noncirrhotic adult participants with low viral burden of chronic HBV infection.

Eligibility

Age

18 - 66 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Male or female ages 18 or older
•Chronic HBV infection for \>/= 6 months
•Chronic HBV infection defined as a positive serum HBsAg, HBV DNA, or HBeAg on 2 occasions at least 6 months apart based on previous or current laboratory documentation
•STRIVE: HBeAg positive or negative, HBV DNA \> 2,000 IU/mL, ALT \> ULN and ≤ 5x ULN
•THRIVE: Must be/have the following, within the 1-year period prior to screening: HBeAg negative, HBV DNA ≤ 2,000 IU/mL, ALT ≤ ULN

Exclusion Criteria

•Any clinically significant chronic or acute medical condition that makes the participant unsuitable for participation
•History of clinically significant liver disease from non-HBV etiology
•History or current evidence of hepatic decompensation
•Co-infection with human immunodeficiency virus (HIV), hepatitis A virus (HAV), hepatitis C virus (HCV), hepatitis D virus (HDV) or hepatitis E virus (HEV).
•History or clinical evidence of alcohol or drug abuse
•STRIVE and THRIVE: Significant fibrosis or cirrhosis
•STRIVE and THRIVE: History of immune complex disease
•STRIVE and THRIVE: History of autoimmune disorder
•STRIVE and THRIVE: History of allergic reactions, hypersensitivity, or intolerance to monoclonal antibodies, antibody fragments, or any excipients of VIR-3434
•STRIVE: Prior NRTI or PEG-IFN therapy
+2 more criteria

Locations (15)

Investigative Site

Clichy, France

Investigative Site

Nice, France

Investigative Site

Rennes, France

Investigative Site

Toulouse, France

Investigative Site

Hong Kong, Sha Tin, Hong Kong

Investigative Site

Hong Kong, Hong Kong

Investigative Site

Chisinau, Moldova

Investigative Site

Bucharest, Romania

Investigative Site

Busan, South Korea

Investigative Site

Seoul, South Korea

Key Dates

Start Date

May 10, 2023

Primary Completion Date

October 15, 2024

Completion Date

August 19, 2025

Last Updated

February 9, 2026

Enrollment

ACTUAL participants

Conditions

Hepatitis B, Chronic

Interventions

VIR-3434

DRUG

VIR-2218

DRUG

TDF

DRUG

PEG-IFNα

DRUG

National Cohort of Patients Co-infected With Hepatitis B and Delta Viruses

NCT04166266

Hepatitis D, ChronicHepatitis B, Chronic

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RECRUITING

Improved Sensitivity Detection of Serum HBsAg and HBsAg Reversion

NCT06550622

Hepatitis B, Chronic

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RECRUITINGEARLY_PHASE1

Efficacy of NA Combined With PEG-IFN-α2b in the Continuous Versus Pulsed Treatment of Patients With Chronic Hepatitis B

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: February 9, 2026Data 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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A Platform Study to Evaluate Investigational Therapies in Chronic Hepatitis B Infection

Inclusion Criteria

Exclusion Criteria

National Cohort of Patients Co-infected With Hepatitis B and Delta Viruses

Improved Sensitivity Detection of Serum HBsAg and HBsAg Reversion

Efficacy of NA Combined With PEG-IFN-α2b in the Continuous Versus Pulsed Treatment of Patients With Chronic Hepatitis B

Digitalized Surveillance Management for Liver Cancer Risk Population in Improving Eearly Diagnosis Efficancy in Chinese Population (dSEARCH)

Study of VIR-2218, VIR-3434, and/or PEG-IFNα in Subjects With Chronic Hepatitis B Virus Infection

Effectiveness of Antiviral Treatment in Cirrhotic Patients with Low-level Hepatitis B Virus DNA Levels