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Active Not Recruiting
NCT05461170
SOLSTICE: Combination Therapy for the Treatment of Chronic Hepatitis D Infection.
Conditions: Hepatitis D, Chronic
Sex: All
Ages: 18 Years – 69 Years
Healthy volunteers: No
Phase: PHASE2
Enrollment: 95
Sponsor: Vir Biotechnology, Inc.
Location: Investigative Site Sofia
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 Criteria
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
Source: ClinicalTrials.gov (NCT05461170). StuddyBuddy aggregates publicly available trial information.