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

VIR-MHB1-V200

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.

2023-05-10

2026-03-01

2027-03-01

Active (not recruiting)

Early phase I

150

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 * STRIVE: History of known contraindication to any interferon product * THRIVE: Prior NRTI therapy \< 24 weeks of study or any prior PEG-IFN therapy

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1', 'PHASE2'], 'designInfo': {'allocation': 'NON_RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 150, 'type': 'ESTIMATED'}}

2024-02-20