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This is a multicenter, open label, randomized Phase 3 clinical study to evaluate the efficacy and safety of the combination of tobevibart + elebsiran for the treatment of chronic hepatitis delta in comparison to delayed treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 (Tobevibart + Elebsiran) | Experimental | Participants will receive treatment with tobevibart + elebsiran for 240 weeks. |
|
| Arm 2 (Tobevibart + Elebsiran) | Experimental | Participants will receive tobevibart + elebsiran after an observational period for 240 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) and alanine aminotransferase (ALT) normalization (ALT </= Upper Limit of Normal [ULN]) at Week 48 for Arm 1 vs at Week 12 for Arm 2 | Up to 48 weeks | |
| Incidence of Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) through Week 12 | Up to 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| HDV RNA < LLOQ, TND at Week 48 for Arm 1 vs Week 12 for Arm 2 | Up to 48 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Investigative Site | Chandler | Arizona | 85224 | United States | ||
| 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 |
|
|
| Los Angeles |
| California |
| 90033 |
| United States |
| Investigative Site | Redwood City | California | 94063 | United States |
| Investigative Site | San Francisco | California | 94143 | United States |
| Investigative Site | DeLand | Florida | 32720 | United States |
| Investigative Site | Chicago | Illinois | 60612 | United States |
| Investigative Site | Baltimore | Maryland | 21287 | United States |
| Investigative Site | Hillsborough | New Jersey | 08844 | United States |
| Investigative Site | New York | New York | 10016 | United States |
| Investigative Site | New York | New York | 10021 | United States |
| Investigative Site | New York | New York | 10029 | United States |
| Investigative Site | Murray | Utah | 84107 | United States |
| Investigative Site | Seattle | Washington | 98105 | United States |
| Investigative Site | Calgary | Alberta | T2N 4Z6 | Canada |
| Investigative Site | Montreal | Quebec | H2L 4E9 | Canada |
| Investigative Site | Montreal | H2X 1R9 | Canada |
| Investigative Site | Ottawa | K1H8L6 | Canada |
| Investigative Site | Québec | G1V 4G2 | Canada |
| Investigative Site | Vancouver | V6Z 2C7 | Canada |
| Investigative Site | Tbilisi | 0102 | Georgia |
| Investigative Site | Tbilisi | 0114 | Georgia |
| Investigative Site | Tbilisi | 0159 | Georgia |
| Investigative Site | Frankfurt | 60590 | Germany |
| Investigative Site | Hanover | 30625 | Germany |
| Investigative Site | Heidelberg | 69120 | Germany |
| Investigative Site | Chisinau | 2025 | Moldova |
| Investigative Site | Auckland | 1010 | New Zealand |
| Investigative Site | Karachi | 74800 | Pakistan |
| Investigative Site | Karachi | 75600 | Pakistan |
| Investigative Site | Lahore | 54800 | Pakistan |
| Investigative Site | Rawalpindi | 46000 | Pakistan |
| Investigative Site | Bucharest | 021105 | Romania |
| Investigative Site | Bucharest | 022328 | Romania |
| Investigative Site | Bucharest | 030303 | Romania |
| Investigative Site | Kyiv | 01135 | Ukraine |
| Investigative Site | London | E1 1BB | United Kingdom |
| Investigative Site | London | SE5 9RS | United Kingdom |
| Investigative Site | Manchester | M8 5RB | United Kingdom |
| Investigative Site | Nottingham | NG7 2UH | United Kingdom |
| ID | Term |
|---|---|
| D006505 | Hepatitis |
| D003699 | Hepatitis D |
| D019701 | Hepatitis D, Chronic |
| ID | Term |
|---|---|
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| 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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