A Study to Evaluate Tobevibart+Elebsiran in Participants With Chronic HDV Infection Not Virologically Suppressed With Bulevirtide
A Phase 3 Randomized, Open-Label Study to Evaluate the Efficacy and Safety of Tobevibart+Elebsiran Combination Therapy in Participants With Chronic HDV Infection Not Virologically Suppressed With Bulevirtide (ECLIPSE 2)
Vir Biotechnology, Inc.
150 participants
Jul 30, 2025
INTERVENTIONAL
Conditions
Summary
This is a multicenter, open label, randomized Phase 3 clinical study to evaluate tobevibart + elebsiran in participants with Chronic HDV Infection not virologically suppressed with bulevirtide
Eligibility
Inclusion Criteria5
- Male or female ages 18 to 70 years at screening
- HDV RNA ≥ 500 IU/mL at screening
- Receiving BLV 2 mg SC QD for ≥ 24 weeks at Day 1
- Noncirrhotic or compensated cirrhotic liver disease at screening
- On NRTI therapy against HBV for at least 12 weeks prior to day 1 or have HBV DNA < 10 IU/ml at screening, currently on locally approved NRTI therapy
Exclusion Criteria8
- Serum ALT ≥ 5 × ULN
- 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
- Current therapy or therapy within 24 weeks of screening with an immunomodulatory agent, immune checkpoint inhibitors, immunosuppressants, cytotoxic or chemotherapeutic agent, or chronic systemic corticosteroids.
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Interventions
Tobevibart administered by subcutaneous injection
Elebsiran administered by subcutaneous injection
Bulevirtide administered by subcutaneous injection
Locations(36)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07128550