A Platform Study to Evaluate Investigational Therapies in Chronic Hepatitis B Infection
Hepatitis B, Chronic
About this trial
This is an interventional treatment trial for Hepatitis B, Chronic focused on measuring Hepatitis B Virus, Chronic Hepatitis B, HBV, Hepatitis
Eligibility 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
Sites / Locations
- Investigative SiteRecruiting
- Investigative Site
- Investigative Site
- Investigative Site
- Investigative SiteRecruiting
- Investigative SiteRecruiting
- Investigative SiteRecruiting
- Investigative SiteRecruiting
- Investigative SiteRecruiting
- Investigative SiteRecruiting
- Investigative Site
- Investigative Site
- Investigative Site
- Investigative SiteRecruiting
- Investigative Site
- Investigative Site
- Investigative Site
- Investigative Site
- Investigative Site
- Investigative Site
- Investigative Site
- Investigative SiteRecruiting
- Investigative SiteRecruiting
- Investigative SiteRecruiting
- Investigative SiteRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm 7
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
STRIVE: Cohort 1a (VIR-3434 + TDF)
STRIVE: Cohort 2a (VIR-3434 + TDF)
STRIVE: Cohort 3a (VIR-3434 + TDF)
STRIVE: Cohort 4a (VIR-3434 + VIR-2218 + TDF)
STRIVE: Cohort 5a (VIR-3434 + VIR-2218 + TDF + PEG-IFNα)
THRIVE: Cohort 1b (VIR-3434 + TDF)
THRIVE: Cohort 2b (VIR-3434 + VIR-2218 + TDF)
Participants will receive combination therapy with VIR-3434 + TDF for 44 weeks total
Participants will receive combination therapy with VIR-3434 + TDF for 44 weeks total
Participants will receive combination therapy with VIR-3434 + TDF for 36 or 40 weeks total
Participants will receive combination therapy with VIR-3434 + VIR-2218 + TDF for 20 or 44 weeks total
Participants will receive combination therapy with VIR-3434 + VIR-2218 +TDF + PEG-IFNα for 48 weeks total
Participants will receive combination therapy with VIR-3434 + TDF for 44 weeks
Participants will receive combination therapy with VIR-3434 + VIR-2218 + TDF for 44 weeks total