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 sites124 target enrollmentOctober 14, 2022

ConditionsChronic Hepatitis D Virus (HDV) Infection MedDRA version: 20.1Level: PTClassification code 10019762Term: Hepatitis DSystem Organ Class: 10021881 - Infections and infestations MedDRA version: 20.0Level: LLTClassification code 10047455Term: Viral hepatitis B without mention of hepatic coma, with hepatitis deltaSystem Organ Class: 10021881 - Infections and infestations Therapeutic area: Diseases [C] - Virus Diseases [C02]

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Chronic Hepatitis D Virus (HDV) Infection
Sponsor: Vir Biotechnology, Inc.
Enrollment: 124
Status: Active, not recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

October 14, 2022

End Date

TBD

Last Updated

last year

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

Vir Biotechnology, Inc.

Eligibility Criteria

Inclusion Criteria

•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) \> ULN and \< 5 x ULN
•7\. Body Mass Index (BMI) \= 18 kg/m2 to \= 40 kg/m2
•Sex and Contraceptive/Barrier Requirements
•8\. Female participants must have a negative pregnancy test or confirmation of postmenopausal status. Postmenopausal status is defined as 12 months with no menses without an alternative medical cause (see Section 10\.7 for additional details). Women of childbearing potential (WOCBP) must have a negative blood pregnancy test at screening and a negative urine pregnancy test on Day 1, cannot be breast feeding, and must be willing to use highly effective methods of contraception (Section 10\.7\) 14 days before study intervention administration through 48 weeks after the last dose of VIR\-2218 or VIR\-3434\. Female participants must also agree to refrain from egg donation and in vitro fertilization from the time of study intervention administration through 48 weeks after the last dose of VIR\-2218 or VIR\-3434\.

Exclusion Criteria

•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