Vir Biotechnology, Inc. will begin a study of VIR-2218 + VIR-3434 in Subjects With Chronic Hepatitis B Virus Infection (MARCH)

 

The condition is cronic Hepatitis B.

The trial begins on the June 2021 and is planned to complete on January 2025.

This is a phase 2 study in which subjects with chronic hepatitis B virus (HBV) infection will receive VIR-2218+ VIR-3434 and will be assessed for safety, tolerability, and efficacy

The population that can be enrolled into this study includes:

• Male or female ages 18 - <66 years - Chronic HBV infection for >/= 6 months - On NRTI therapy for >/= 2 months at the time of screening Exclusion Criteria: - Any clinically significant chronic or acute medical condition that makes the participant unsuitable for participation - Significant fibrosis or cirrhosis - History or evidence of drug or alcohol abuse - History of chronic liver disease from any cause other than chronic HBV infection - History of hepatic decompensation - History of anaphylaxis - History of allergic reactions to monoclonal antibodies or antibody fragments - History of immune complex disease - Active infection with HIV, HCV, or hepatitis Delta virus (HDV).

Patients with the following pathologies will be excluded from participation:

• Any clinically significant chronic or acute medical condition that makes the participant unsuitable for participation - Significant fibrosis or cirrhosis - History or evidence of drug or alcohol abuse - History of chronic liver disease from any cause other than chronic HBV infection - History of hepatic decompensation - History of anaphylaxis - History of allergic reactions to monoclonal antibodies or antibody fragments - History of immune complex disease - Active infection with HIV, HCV, or hepatitis Delta virus (HDV).

The link to the complete study profile: https://ichgcp.net/clinical-trials-registry/NCT04856085