A Phase 2 Study to Evaluate Efficacy, Safety and Tolerability of VIR-2218 and VIR-3434 in Participants with Chronic Hepatitis D Virus Infection (SOLSTICE) - SOLSTICE

Vir Biotechnology, Inc.0 sites4 target enrollmentTBD

Overview

No summary available.

Registry

who.int

Start Date

TBD

End Date

TBD

Last Updated

last year

Study Type

Interventional

Sponsor

•Age 1\. Age \>\= 18 (or age of legal consent, whichever is older) to \< 70 years at
•the time of screening Type of Participant and Disease Characteristics 2\.
•Chronic HBV infection defined as a positive serum HBsAg, HBV DNA, or HBeAg on 2
•occasions at least 6 months apart based on previous (within the past 12 months)
•or current laboratory documentation (any combination of these tests performed 6
•months apart is acceptable) 3\. On locally approved NRTI therapy for at least 12
•weeks prior to Day 1 4\. HBsAg \> 0\.05 IU/mL at screening 5\. Positive HDV
•antibody for at least 6 months prior to screening and HDV RNA \>\= 500 IU/mL at
•screening 6\. Serum alanine aminotransferase (ALT) and aspartate
•aminotransferase (AST) \> ULN and \< 5 x ULN Weight 7\. Body Mass Index (BMI) \>\= 18

•Medical Conditions 1\. History of clinically significant liver disease from
•non\-HBV and non\-HDV etiology as determined by the investigator 2\. History of
•clinically significant immune complex disease as determined by the investigator
•3\. History of clinically significant autoimmune disorder as determined by the
•investigator 4\. History of HBV\-related extrahepatic disease, including but not
•limited to HBV\-related rash, arthritis, or glomerulonephritis 5\. History of
•allergic reactions, hypersensitivity, or intolerance to study intervention, its
•metabolites or excipients 6\. Anti\-HBs \>10 mIU/L at screening 7\. Corrected QT
•interval (QTc) \> 450 milliseconds 8\. ALT or AST \>\= 5x ULN 9\. Total bilirubin \>
•2\.0 mg/dL 10\. Serum albumin \< 30 g/L 11\. Absolute neutrophil count \< 1,000/mm3

Not specified