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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 | Experimental | Participants will receive treatment with tobevibart + elebsiran up to 240 weeks. |
|
| Arm 2 | Experimental | Participants will receive Bulevirtide for 24 weeks and switch to receive tobevibart + elebsiran for additional 216 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tobevibart | Drug | Tobevibart administered by subcutaneous injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| HDV RNA < Lower Limit of Quantification (LLOQ), Target not detected (TND) at Week 24 | Week 24 | |
| HDV RNA < Lower Limit of Quantification (LLOQ), Target not detected (TND) 24 weeks after end of treatment. | 24 Weeks after End of Treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) through Week 24, Week 48, Week 96, Week 120, Week 144, Week 192, and Week 240 | Week 24, Week 48, Week 96, Week 120, Week 144, Week 192, and Week 240 | |
| HDV RNA < Lower Limit of Quantification (LLOQ), Target not detected (TND) at Week 48, Week 96, Week 120, Week 144, Week 192 and Week 240 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Study Injury | Contact | 415-654-5281 | clinicaltrials@vir.bio |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Investigative Site | Recruiting | Innsbruck | 6020 | Austria | ||
| Investigative Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41586499 | Derived | Noack J, Anglero-Rodriguez Y, Gall J, Zhou J, LeBlanc S, Liebow A, Bakardjiev A, Hebner CM, Purcell LA, Jadhav V, Corti D, Lempp FA. Combination therapy with tobevibart and elebsiran potently reduces hepatitis B virus surface antigen levels in preclinical in vivo models. Antimicrob Agents Chemother. 2026 Mar 4;70(3):e0112725. doi: 10.1128/aac.01127-25. Epub 2026 Jan 26. |
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| Elebsiran | Drug | Elebsiran administered by subcutaneous injection |
|
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| Bulevirtide | Drug | Bulevirtide administered by subcutaneous injection |
|
|
| Week 48 , Week 96, Week 120, Week 144, Week 192 and Week 240 |
| Change from baseline in ALT at Week 24, Week 48, Week 96, Week 120, Week 144, Week 192, and Week 240 | Week 24, Week 48, Week 96, Week 120, Week 144, Week 192, and Week 240 |
| Recruiting |
| Vienna |
| 1090 |
| Austria |
| Investigative Site | Recruiting | Bobigny | 93009 | France |
| Investigative Site | Recruiting | Clichy | 92110 | France |
| Investigative Site | Recruiting | Créteil | 94000 | France |
| Investigative Site | Recruiting | Le Chesnay | 78150 | France |
| Investigative Site | Recruiting | Limoges | 87000 | France |
| Investigative Site | Recruiting | Lyon | 69004 | France |
| Investigative Site | Recruiting | Montpellier | 34295 | France |
| Investigative Site | Recruiting | Pessac | 33604 | France |
| Investigative Site | Recruiting | Rennes | 35033 | France |
| Investigative Site | Recruiting | Toulouse | 31059 | France |
| Investigative Site | Recruiting | Villejuif | 94804 | France |
| Investigative Site | Recruiting | Berlin | 13353 | Germany |
| Investigative Site | Recruiting | Essen | 45147 | Germany |
| Investigative Site | Recruiting | Frankfurt am Main | 60590 | Germany |
| Investigative Site | Recruiting | Hanover | 30625 | Germany |
| Investigative Site | Recruiting | Bergamo | 24127 | Italy |
| Investigative Site | Recruiting | Foggia | 71122 | Italy |
| Investigative Site | Recruiting | Milan | 20089 | Italy |
| Investigative Site | Recruiting | Milan | 20122 | Italy |
| Investigative Site | Recruiting | Pisa | 56124 | Italy |
| Investigative Site | Recruiting | Torino | 10122 | Italy |
| Investigative Site | Recruiting | Torino | 10126 | Italy |
| Investigative Site | Recruiting | Bucharest | 021105 | Romania |
| Investigative Site | Recruiting | Bucharest | 022328 | Romania |
| Investigative Site | Recruiting | Bucharest | 030303 | Romania |
| Investigative Site | Recruiting | Craiova | 200073 | Romania |
| Investigative Site | Recruiting | Barcelona | 08035 | Spain |
| Investigative Site | Recruiting | Barcelona | 08036 | Spain |
| Investigative Site | Recruiting | Madrid | 28007 | Spain |
| Investigative Site | Recruiting | Madrid | 28046 | Spain |
| Investigative Site | Recruiting | Santander | 39008 | Spain |
| Investigative Site | Recruiting | London | E1 1FR | United Kingdom |
| Investigative Site | Recruiting | London | SE5 9NU | United Kingdom |
| Investigative Site | Recruiting | London | W2 1NY | United Kingdom |
| Investigative Site | Recruiting | Manchester | M8 5RB | United Kingdom |
| Investigative Site | Recruiting | Nottingham | NG7 2UH | United Kingdom |
| ID | Term |
|---|---|
| D006505 | Hepatitis |
| D003699 | Hepatitis D |
| D019701 | Hepatitis D, Chronic |
| D004066 | Digestive System Diseases |
| D008107 | Liver Diseases |
| ID | Term |
|---|---|
| D006525 | Hepatitis, Viral, Human |
| D014777 | Virus Diseases |
| D007239 | Infections |
| D012327 | RNA Virus Infections |
| D006521 | Hepatitis, Chronic |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C000718249 | bulevirtide |
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