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Recruiting NCT05612581

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

Conditions: Hepatitis B, Chronic

Sex: All
Ages: 18 Years – 66 Years
Phase: PHASE1, PHASE2
Enrollment: 150
Sponsor: Vir Biotechnology, Inc.

Location: Australia

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.

Eligibility Criteria

Inclusion Criteria:Male or female ages 18 or olderChronic HBV infection for >/= 6 monthsChronic 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 documentationSTRIVE: HBeAg positive or negative, HBV DNA > 2,000 IU/mL, ALT > ULN and ≤ 5x ULNTHRIVE: Must be/have the following, within the 1-year period prior to screening: HBeAg negative, HBV DNA ≤ 2,000 IU/mL, ALT ≤ ULNExclusion Criteria:Any clinically significant chronic or acute medical condition that makes the participant unsuitable for participationHistory of clinically significant liver disease from non-HBV etiologyHistory or current evidence of hepatic decompensationCo-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 abuseSTRIVE and THRIVE: Significant fibrosis or cirrhosisSTRIVE and THRIVE: History of immune complex diseaseSTRIVE and THRIVE: History of autoimmune disorderSTRIVE and THRIVE: History of allergic reactions, hypersensitivity, or intolerance to monoclonal antibodies, antibody fragments, or any excipients of VIR-3434STRIVE: Prior NRTI or PEG-IFN therapySTRIVE: History of known contraindication to any interferon productTHRIVE: Prior NRTI therapy < 24 weeks of study or any prior PEG-IFN therapy

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05612581). StuddyBuddy aggregates publicly available trial information.