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This is a phase 2 trial in which participants with chronic hepatitis D virus (HDV) infection will receive VIR-2218 and/or VIR-3434 and be assessed for safety, tolerability, and efficacy
Participants may be enrolled into Cohort 1 (1a and 1b) or Cohort 2 (2a, 2b1 or 2b2, 2c), 3, 4, and 5. All participants still receiving VIR-2218 or VIR-3434 monotherapy at the time of implementation of Protocol Amendment 4 will switch to combination therapy at Week 132 (Cohort 2a, 2b1/2b2) or Week 112 (Cohort 3).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1a (VIR-2218) | Experimental | Participants will receive multiple doses of VIR-2218 for up to 96 weeks total. |
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| Cohort 1b (VIR-3434) | Experimental | Participants will receive multiple doses of VIR-3434 for up to 96 weeks total. |
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| Cohort 2a (VIR-2218) | Experimental | Participants will receive multiple doses of VIR-2218 for up to 132 weeks, then assign to Cohort 2c. |
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| Cohort 2b1 (VIR-3434) | Experimental | Participants will receive multiple doses of VIR-3434 for up to 132 weeks, then assign to Cohort 2c. |
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| Cohort 2b2 (VIR-3434) | Experimental | Participants will receive multiple doses of VIR-3434 for up to 132 weeks, then assign to Cohort 2c. |
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| Cohort 2c (VIR-2218 + VIR-3434) | Experimental |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VIR-2218 | Drug | VIR-2218 given by subcutaneous injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of participants with undetectable HDV RNA (< limit of detection [LOD]) or ≥ 2 log10 decrease in HDV RNA from baseline and alanine aminotransferase (ALT) normalization (ALT < upper limit of normal [ULN]) at Week 24 | Up to 24 Weeks | |
| Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) | Up to 360 Weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of participants with undetectable HDV RNA (less than LOD) or greater than/equal to 2 log10 decrease in HDV RNA from baseline and ALT normalization at Week 12, Week 48, Week 72, Week 96, Week 144, Week 192, Week 240, Week 288, and Week 336. | Up to 336 Weeks | |
| Proportion of participants with undetectable HDV RNA (less than LOD) or greater than/equal to 2 log10 decrease in HDV RNA from baseline at Week 12, Week 24, Week 48, Week 72, Week 96, Week 144, Week 192, Week 240, Week 288, and Week 336. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Investigative Site | Sofia | 1407 | Bulgaria | |||
| 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. | |
| 41211943 |
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Participants will receive multiple doses of VIR-2218 + VIR-3434 for up to 336 weeks. |
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| Cohort 3 (VIR-3434) | Experimental | Participants will receive multiple doses of VIR-3434 for up to 112 weeks, then assign to Cohort 2c. |
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| Cohort 4 (NRTI) | Placebo Comparator | Participants will receive NRTI for 12 weeks, then assign to Cohort 2c or Cohort 3. |
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| Cohort 5 (VIR-2218) | Experimental | Participants will receive multiple doses of VIR-2218 for 12 weeks, then assign to Cohort 2c. |
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| VIR-3434 | Drug | VIR-3434 given by subcutaneous injection |
|
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| NRTI | Drug | NRTI given orally. |
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| Up to 336 Weeks |
| Proportion of participants with undetectable HDV RNA (less than LOD) at Week 12, Week 24, Week 48, Week 72, Week 96, Week 144, Week 192, Week 240, Week 288, and Week 336. | Up to 336 Weeks |
| Proportion of participants with HDV RNA < lower limit of quantitation (LLOQ) at Week 12, Week 24, Week 48, Week 72, Week 96, Week 144, Week 192, Week 240, Week 288, and Week 336. | Up to 336 Weeks |
| Change from baseline in HDV RNA at Week 12, Week 24, Week 48, Week 72, Week 96, Week 144, Week 192, Week 240, Week 288, and Week 336. | Up to 336 Weeks |
| Proportion of participants with ALT normalization at Week 12, Week 24, Week 48, Week 72, Week 96, Week 144, Week 192, Week 240, Week 288, and Week 336. | Up to 336 Weeks |
| Incidence of anti-drug antibodies (ADA) and titers of ADA to VIR-3434 at specified study visits up to Week 336 (for cohorts with VIR3434) | Up to 336 Weeks |
| Change from baseline in liver fibrosis at Week 48, Week 96, Week 144, Week 192, Week 240, Week 288, and Week 336. | Liver Fibrosis will be measured by conventional Transient Elastography imaging technique reported in kPa. | Up to 336 Weeks. |
| Change from baseline in Model for End Stage Liver Disease (MELD) score at Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96, Week 144, Week 192, Week 240, Week 288, and Week 336. | MELD score will be calculated using serum bilirubin, serum creatinine, and International Normalized Ratio. | Up to 336 Weeks |
| Change from baseline in Child-Pugh-Turcotte (CPT) score at Week 24, Week 48, Week 72, Week 96, Week 144, Week 192, Week 240, Week 288, and Week 336. | Up to 336 Weeks |
| Sofia |
| 1431 |
| Bulgaria |
| Investigative Site | Stara Zagora | 6003 | Bulgaria |
| Investigative Site | Clichy | 92110 | France |
| Investigative Site | Pessac | 33600 | France |
| Investigative Site | Rennes | 35000 | France |
| Investigative Site | Toulouse | 31000 | France |
| Investigative Site | Frankfurt | 60596 | Germany |
| Investigative Site | Hanover | 30625 | Germany |
| Investigative Site | Tübingen | 72076 | Germany |
| Investigative Site | Milan | 20122 | Italy |
| Investigative Site | Pisa | 56124 | Italy |
| Investigative Site | Chisinau | MD-2025 | Moldova |
| Investigative Site | Rotterdam | 3015 GD | Netherlands |
| Investigative Site | Auckland | 1010 | New Zealand |
| Investigative Site | Bucharest | 021105 | Romania |
| Investigative Site | Birmingham | B15 2TT | United Kingdom |
| Investigative Site | London | E1 1RF | United Kingdom |
| Investigative Site | London | SE5 9RS | United Kingdom |
| Investigative Site | Manchester | M8 5RB | United Kingdom |
| Derived |
| Asselah T, Chattergoon MA, Jucov A, Streinu-Cercel A, Lampertico P, Wedemeyer H, Kennedy PT, Gane EJ, Bullard BL, Chow S, Santos D, Camus G, Lu Y, Pilowa C, Hwang C, Correll T, Agarwal K; SOLSTICE Trial Investigators. A Phase 2 Trial of Tobevibart plus Elebsiran in Hepatitis D. N Engl J Med. 2026 Jan 22;394(4):343-353. doi: 10.1056/NEJMoa2508827. Epub 2025 Nov 9. |
| ID | Term |
|---|---|
| D019701 | Hepatitis D, Chronic |
| D006505 | Hepatitis |
| D003699 | Hepatitis D |
| ID | Term |
|---|---|
| D006525 | Hepatitis, Viral, Human |
| D014777 | Virus Diseases |
| D007239 | Infections |
| D012327 | RNA Virus Infections |
| D006521 | Hepatitis, Chronic |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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