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

• Status: Not yet recruiting
• Trial end date: 2027-03-01
• Target enrollment: 0
• Participant gender: All

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 HBV infection.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Vir Biotechnology, Inc.

Criteria

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