VIR-2218: VIR-2218 given by subcutaneous injection
VIR-3434: VIR-3434 given by subcutaneous injection
NRTI: NRTI given orally.
Study 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
Eligibility
Sex
ALL
Min age
18 Years
Max age
69 Years
Healthy volunteers
No
Inclusion Criteria:
* Male or female ages 18 to \< 70 years at screening
* Chronic HDV infection for \>/= 6 months
* On NRTI therapy for at least 12 weeks prior to day 1
* ALT\>ULN and \< 5x ULN
* Non-cirrhotic and CPT-A cirrhotic
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.
* Anti-HBs \>10 mIU/mL at screening
Primary outcome measure(s)
Proportion of participants with undetectable HDV RNA (< limit of detection [LOD]) or ≥ 2 log10 decrease in HDV RNA from baseline and alanine aminotransferase (ALT) normalization (ALT < upper limit of normal [ULN]) at Week 24 — Up to 24 Weeks
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) — Up to 360 Weeks
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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