SOLSTICE: Combination Therapy for the Treatment of Chronic Hepatitis D Infection

• Status: Not yet recruiting
• Trial end date: 2026-12-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a phase 2 trial in which participants with chronic hepatitis D virus (HDV) infection will receive VIR-2218 and/or VIR-3434 and be assessed for safety, tolerability, and efficacy

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Vir Biotechnology, Inc.

Criteria

Inclusion Criteria:

• Male or female ages 18 -< 70 years

• Chronic HDV infection for >/= 6 months

• On NRTI therapy for >/= 2 months at the time of screening

Exclusion Criteria:

• Any clinically significant chronic or acute medical or psychiatric condition that makes the participant unsuitable for participation.

• History of significant liver disease from non-HBV or non-HDV etiology

• History of allergic reactions, hypersensitivity, or intolerance to study drug, its metabolites, or excipients.

• History of anaphylaxis

• History of immune complex disease

• History of autoimmune disorder

• History or evidence of alcohol or drug abuse

• Prior or concomitant therapy with an immunomodulatory agent, IFN-alpha, cytotoxic or chemotherapeutic agent, or chronic corticosteroids.