A Platform Study to Evaluate Investigational Therapies in Chronic Hepatitis B Infection
NCT ID: NCT05612581
Last Updated: 2025-11-26
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1/PHASE2
33 participants
INTERVENTIONAL
2023-05-10
2025-08-19
Brief Summary
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Detailed Description
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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
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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STRIVE: Cohort 5a (VIR-3434 + VIR-2218 + TDF + PEG-IFNα)
Participants will receive combination therapy with VIR-3434 + VIR-2218 +TDF + PEG-IFNα for 48 weeks total
VIR-3434
VIR-3434 given by subcutaneous injection
VIR-2218
VIR-2218 given by subcutaneous injection
TDF
TDF given orally
PEG-IFNα
PEG-IFNα given by subcutaneous injection
THRIVE: Cohort 1b (VIR-3434 + TDF)
Participants will receive combination therapy with VIR-3434 + TDF for 44 weeks
VIR-3434
VIR-3434 given by subcutaneous injection
TDF
TDF given orally
THRIVE: Cohort 2b (VIR-3434 + VIR-2218 + TDF)
Participants will receive combination therapy with VIR-3434 + VIR-2218 + TDF for 44 weeks total
VIR-3434
VIR-3434 given by subcutaneous injection
VIR-2218
VIR-2218 given by subcutaneous injection
TDF
TDF given orally
STRIVE: Cohort 1a (VIR-3434 + TDF)
Participants will receive combination therapy with VIR-3434 + TDF for 44 weeks total
VIR-3434
VIR-3434 given by subcutaneous injection
TDF
TDF given orally
STRIVE: Cohort 2a (VIR-3434 + TDF)
Participants will receive combination therapy with VIR-3434 + TDF for 44 weeks total
VIR-3434
VIR-3434 given by subcutaneous injection
TDF
TDF given orally
STRIVE: Cohort 3a (VIR-3434 + TDF)
Participants will receive combination therapy with VIR-3434 + TDF for 36 or 40 weeks total
VIR-3434
VIR-3434 given by subcutaneous injection
TDF
TDF given orally
STRIVE: Cohort 4a (VIR-3434 + VIR-2218 + TDF)
Participants will receive combination therapy with VIR-3434 + VIR-2218 + TDF for 20 or 44 weeks total
VIR-3434
VIR-3434 given by subcutaneous injection
VIR-2218
VIR-2218 given by subcutaneous injection
TDF
TDF given orally
Interventions
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VIR-3434
VIR-3434 given by subcutaneous injection
VIR-2218
VIR-2218 given by subcutaneous injection
TDF
TDF given orally
PEG-IFNα
PEG-IFNα given by subcutaneous injection
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
* STRIVE: History of known contraindication to any interferon product
* THRIVE: Prior NRTI therapy \< 24 weeks of study or any prior PEG-IFN therapy
18 Years
66 Years
ALL
No
Sponsors
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Vir Biotechnology, Inc.
INDUSTRY
Responsible Party
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Locations
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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
Investigative Site
Yangsan, , South Korea
Investigative Site
Glasgow, , United Kingdom
Investigative Site
London, , United Kingdom
Investigative Site
London, , United Kingdom
Investigative Site
Manchester, , United Kingdom
Countries
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Provided Documents
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Document Type: Study Protocol: PREVAIL
Document Type: Study Protocol: STRIVE
Document Type: Study Protocol: THRIVE
Document Type: Statistical Analysis Plan
Other Identifiers
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VIR-MHB1-V200
Identifier Type: -
Identifier Source: org_study_id
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