A Study to Evaluate Tobevibart+Elebsiran in Participants With Chronic HDV Infection Not Virologically Suppressed With Bulevirtide
NCT ID: NCT07128550
Last Updated: 2025-11-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
150 participants
INTERVENTIONAL
2025-07-30
2031-07-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Arm 1
Participants will receive treatment with tobevibart + elebsiran up to 240 weeks.
Tobevibart
Tobevibart administered by subcutaneous injection
Elebsiran
Elebsiran administered by subcutaneous injection
Arm 2
Participants will receive Bulevirtide for 24 weeks and switch to receive tobevibart + elebsiran for additional 216 weeks
Tobevibart
Tobevibart administered by subcutaneous injection
Elebsiran
Elebsiran administered by subcutaneous injection
Bulevirtide
Bulevirtide administered by subcutaneous injection
Interventions
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Tobevibart
Tobevibart administered by subcutaneous injection
Elebsiran
Elebsiran administered by subcutaneous injection
Bulevirtide
Bulevirtide administered by subcutaneous injection
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. HDV RNA ≥ 500 IU/mL at screening
3. Receiving BLV 2 mg SC QD for ≥ 24 weeks at Day 1
4. Noncirrhotic or compensated cirrhotic liver disease at screening
5. 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 Criteria
2. Any clinically significant chronic or acute medical or psychiatric condition that makes the participant unsuitable for participation.
3. History of significant liver disease from non-HBV or non-HDV etiology
4. History of allergic reactions, hypersensitivity, or intolerance to study drug, its metabolites, or excipients.
5. History of anaphylaxis
6. History of immune complex disease
7. History of autoimmune disorder
8. 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.
18 Years
70 Years
ALL
No
Sponsors
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Vir Biotechnology, Inc.
INDUSTRY
Responsible Party
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Locations
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Investigative Site
Bobigny, , France
Investigative Site
Clichy, , France
Investigative Site
Créteil, , France
Investigative Site
Le Chesnay, , France
Investigative Site
Limoges, , France
Investigative Site
Lyon, , France
Investigative Site
Montpellier, , France
Investigative Site
Pessac, , France
Investigative Site
Rennes, , France
Investigative Site
Toulouse, , France
Investigative Site
Villejuif, , France
Investigative Site
Berlin, , Germany
Investigative Site
Frankfurt am Main, , Germany
Investigative Site
Hanover, , Germany
Investigative Site
Milan, , Italy
Investigative Site
Bucharest, , Romania
Investigative Site
Bucharest, , Romania
Investigative Site
Bucharest, , Romania
Investigative Site
Craiova, , Romania
Investigative Site
Barcelona, , Spain
Investigative Site
Barcelona, , Spain
Investigative Site
Madrid, , Spain
Investigative Site
Santander, , Spain
Investigative Site
London, , United Kingdom
Investigative Site
London, , United Kingdom
Investigative Site
Nottingham, , United Kingdom
Countries
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Central Contacts
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Other Identifiers
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VIR-CHDV-V205
Identifier Type: -
Identifier Source: org_study_id