PREVAIL
Research type
Research Study
Full title
A Platform Study Evaluating the Efficacy and Safety of Investigational Therapies in Participants with Chronic Hepatitis B Infection (PREVAIL)
IRAS ID
1006814
Contact name
Daniel Cloutier
Contact email
Sponsor organisation
Vir Biotechnology, Inc.
Eudract number
2022-002014-16
Clinicaltrials.gov Identifier
Research summary
The Sponsor conducting this study is Vir Biotechnology Inc. Chronic hepatitis B virus (HBV) infection remains an important global public health problem with significant morbidity and mortality. It is estimated that approximately 300 million people are living with chronic HBV infection worldwide. Chronic HBV infection leads to serious sequelae, including cirrhosis, liver failure, hepatocellular carcinoma (HCC), and death. Almost 800,000 people worldwide are estimated to die annually due to chronic HBV infection. Current treatment options for chronic HBV infection are limited. This is a platform study with one master protocol (VIR-MHB1-V200) which describes the overall study outline, study populations, common objectives and endpoints, common inclusion and exclusion criteria, common elements of randomisation scheme, statistical methodology, general study assessments (which include efficacy and safety assessments), and the planned analyses. The sub-protocols will identify specific investigational therapy(ies), the population(s) in which they will be tested, the study-specific design, and any additional information pertinent to the investigational intervention(s) included. The Master Protocol should be read in conjunction with each sub-protocol.
The investigational drug, VIR-2218 is a synthetic small interfering ribonucleic (siRNA) therapeutic that has been shown to reduce HBsAg in persons with HBV infection. VIR-3434 is a monoclonal antibody that recognises and binds HBsAg and prevents HBV virions from infecting liver cells. VIR-3434 has also been found to substantially reduce HBsAg in persons with HBV infection alone. The combination of VIR-2218 and VIR-3434 is anticipated to result in sustained reductions in HBsAg and thus HBV virus. The current sub-protocols will evaluate combinations of VIR-3434 and VIR-2218.
REC name
South Central - Hampshire A Research Ethics Committee
REC reference
22/SC/0468
Date of REC Opinion
14 Apr 2023
REC opinion
Further Information Favourable Opinion