Actively Recruiting
A Study to Evaluate Tobevibart+Elebsiran in Participants With Chronic HDV Infection Not Virologically Suppressed With Bulevirtide
Led by Vir Biotechnology, Inc. · Updated on 2026-05-06
150
Participants Needed
38
Research Sites
308 weeks
Total Duration
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AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
A Study to Evaluate Tobevibart+Elebsiran in Participants With Chronic HDV Infection Not Virologically Suppressed With Bulevirtide
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female ages 18 to 70 years at screening
- HDV RNA 500 IU/mL at screening
- Receiving bulevirtide 2 mg subcutaneously once daily for at least 24 weeks at Day 1
- Noncirrhotic or compensated cirrhotic liver disease at screening
- On nucleoside reverse transcriptase inhibitor 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
You will not qualify if you...
- Serum ALT 5 times upper limit of normal
- 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 causes
- 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 prior to screening with immunomodulatory agents, immune checkpoint inhibitors, immunosuppressants, cytotoxic or chemotherapeutic agents, or chronic systemic corticosteroids
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 38 locations
1
Investigative Site
Innsbruck, Austria, 6020
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2
Investigative Site
Vienna, Austria, 1090
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3
Investigative Site
Bobigny, France, 93009
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4
Investigative Site
Clichy, France, 92110
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5
Investigative Site
Créteil, France, 94000
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6
Investigative Site
Le Chesnay, France, 78150
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7
Investigative Site
Limoges, France, 87000
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8
Investigative Site
Lyon, France, 69004
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9
Investigative Site
Montpellier, France, 34295
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10
Investigative Site
Pessac, France, 33604
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11
Investigative Site
Rennes, France, 35033
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12
Investigative Site
Toulouse, France, 31059
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13
Investigative Site
Villejuif, France, 94804
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14
Investigative Site
Berlin, Germany, 13353
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15
Investigative Site
Essen, Germany, 45147
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16
Investigative Site
Frankfurt am Main, Germany, 60590
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17
Investigative Site
Hanover, Germany, 30625
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18
Investigative Site
Bergamo, Italy, 24127
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19
Investigative Site
Foggia, Italy, 71122
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20
Investigative Site
Milan, Italy, 20089
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21
Investigative Site
Milan, Italy, 20122
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22
Investigative Site
Pisa, Italy, 56124
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23
Investigative Site
Torino, Italy, 10122
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24
Investigative Site
Torino, Italy, 10126
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25
Investigative Site
Bucharest, Romania, 021105
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26
Investigative Site
Bucharest, Romania, 022328
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27
Investigative Site
Bucharest, Romania, 030303
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28
Investigative Site
Craiova, Romania, 200073
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29
Investigative Site
Barcelona, Spain, 08035
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30
Investigative Site
Barcelona, Spain, 08036
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31
Investigative Site
Madrid, Spain, 28007
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32
Investigative Site
Madrid, Spain, 28046
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33
Investigative Site
Santander, Spain, 39008
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34
Investigative Site
London, United Kingdom, E1 1FR
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35
Investigative Site
London, United Kingdom, SE5 9NU
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36
Investigative Site
London, United Kingdom, W2 1NY
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37
Investigative Site
Manchester, United Kingdom, M8 5RB
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38
Investigative Site
Nottingham, United Kingdom, NG7 2UH
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Research Team
S
Study Injury
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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