A Study to Evaluate Tobevibart+Elebsiran in Participants With Chronic HDV Infection Not Virologically Suppressed With Bulevirtide

NCT07128550 — Phase 3, Active not recruiting, 150 participants, Vir Biotechnology, Inc.
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A Phase 3 Randomized, Open-Label Study to Evaluate the Efficacy and Safety of Tobevibart+Elebsiran Combination Therapy in Participants With Chronic HDV Infection Not Virologically Suppressed With Bulevirtide (ECLIPSE 2)

RegistryNCT07128550
StatusActive not recruiting
PhasePhase 3
Study typeInterventional; randomized, parallel, masking: none, treatment
Enrollment150 (Estimated)
SponsorVir Biotechnology, Inc. (Industry)
ConditionsViral Hepatitis
InterventionsTobevibart, Elebsiran, Bulevirtide (Drug)
Datesstart 2025-07-30, primary completion 2026-12-01 (estimated), completion 2031-07-01 (estimated), first posted 2025-08-19, last updated 2026-07-13
Locations38 sites in Austria, France, Germany, Italy, Romania, Spain, United Kingdom

Related Papers Related Patents Related Grants Related Experts
All trials for Viral Hepatitis All trials of Tobevibart All trials of Elebsiran

-Summary

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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+Arms and interventions

ArmTypeInterventionsDescription
Arm 1ExperimentalDrug: Tobevibart; Drug: ElebsiranParticipants will receive treatment with tobevibart + elebsiran up to 240 weeks.
Arm 2ExperimentalDrug: Tobevibart; Drug: Elebsiran; Drug: BulevirtideParticipants will receive Bulevirtide for 24 weeks and switch to receive tobevibart + elebsiran for additional 216 weeks
  • Tobevibart (Drug), also known as VIR-3434: Tobevibart administered by subcutaneous injection
  • Elebsiran (Drug), also known as VIR-2218: Elebsiran administered by subcutaneous injection
  • Bulevirtide (Drug), also known as Hepcludex: Bulevirtide administered by subcutaneous injection

+Outcome measures

Primary outcomes

  • 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]

Secondary outcomes

  • 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 [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]

+Eligibility

Sex: All, ages: 18 Years to 70 Years

Inclusion Criteria:

1. Male or female ages 18 to 70 years at screening
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:

1. Serum ALT ≥ 5 × ULN
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.

+Locations (38)

FacilityCityCountryStatus
Investigative SiteInnsbruckAustria
Investigative SiteViennaAustria
Investigative SiteBobignyFrance
Investigative SiteClichyFrance
Investigative SiteCréteilFrance
Investigative SiteLe ChesnayFrance
Investigative SiteLimogesFrance
Investigative SiteLyonFrance
Investigative SiteMontpellierFrance
Investigative SitePessacFrance
Investigative SiteRennesFrance
Investigative SiteToulouseFrance
Investigative SiteVillejuifFrance
Investigative SiteBerlinGermany
Investigative SiteEssenGermany
Investigative SiteFrankfurt am MainGermany
Investigative SiteHanoverGermany
Investigative SiteBergamoItaly
Investigative SiteFoggiaItaly
Investigative SiteMilanItaly
Investigative SiteMilanItaly
Investigative SitePisaItaly
Investigative SiteTorinoItaly
Investigative SiteTorinoItaly
Investigative SiteBucharestRomania
Investigative SiteBucharestRomania
Investigative SiteBucharestRomania
Investigative SiteCraiovaRomania
Investigative SiteBarcelonaSpain
Investigative SiteBarcelonaSpain
Investigative SiteMadridSpain
Investigative SiteMadridSpain
Investigative SiteSantanderSpain
Investigative SiteLondonUnited Kingdom
Investigative SiteLondonUnited Kingdom
Investigative SiteLondonUnited Kingdom
Investigative SiteManchesterUnited Kingdom
Investigative SiteNottinghamUnited Kingdom

+Publications

  • Results publication: 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. PMID 41586499