NCT05612581

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)

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 33 (actual)
• Sponsor: Vir Biotechnology, Inc. · Industry
• Sex: All
• Age: 18 Years – 66 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Hepatitis B, Chronic

Interventions

Type	Name	Description
DRUG	VIR-3434	VIR-3434 given by subcutaneous injection
DRUG	VIR-2218	VIR-2218 given by subcutaneous injection
DRUG	TDF	TDF given orally
DRUG	PEG-IFNα	PEG-IFNα given by subcutaneous injection

Timeline

• Start date: 2023-05-10
• Primary completion: 2024-10-15
• Completion: 2025-08-19
• First posted: 2022-11-10
• Last updated: 2026-02-09
• Results posted: 2025-11-26

Locations

15 sites across 6 countries: France, Hong Kong, Moldova, Romania, South Korea, United Kingdom

Regulatory

• FDA-regulated drug study