A Study to Evaluate Tobevibart+Elebsiran Versus Bulevirtide in Chronic HDV Infection
A Phase 2b Randomized, Open-Label Study to Evaluate the Efficacy and Safety of Tobevibart+Elebsiran Combination Therapy Versus Bulevirtide in Participants With Chronic HDV Infection (ECLIPSE 3)
1 other identifier
interventional
100
11 countries
31
Brief Summary
A Study to Evaluate Tobevibart+Elebsiran versus Bulevirtide in Chronic HDV Infection
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Aug 2025
Longer than P75 for phase_2
31 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 5, 2025
CompletedFirst Submitted
Initial submission to the registry
August 19, 2025
CompletedFirst Posted
Study publicly available on registry
August 27, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
July 1, 2030
January 16, 2026
January 1, 2026
1.2 years
August 19, 2025
January 15, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
HDV RNA < Lower Limit of Quantification (LLOQ), Target not detected (TND) at Week 48
Week 48
HDV RNA < Lower Limit of Quantification (LLOQ), Target not detected (TND) 24 weeks after end of treatment
24 Weeks after End of Treatment
Incidence of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) through Week 48
Week 48
Secondary Outcomes (5)
Change from baseline in HDV RNA at Week 48
Week 48
Change from baseline in ALT at Week 48
Week 48
HDV RNA < Lower Limit of Quantification (LLOQ), Target not detected (TND) at Week 96, Week 120, Week 144, Week 192 and Week 240
Week 96, Week 120, Week 144, Week 192 and Week 240
Change from baseline in HDV RNA at Week 96, Week 120, Week 144, Week 192 and Week 240
Week 96, Week 120, Week 144, Week 192 and Week 240
Change from baseline in ALT at Week 96, Week 120, Week 144, Week 192 and Week 240
Week 96 to Week 120, Week 144, Week 192 and Week 240
Study Arms (2)
Arm 1
EXPERIMENTALParticipants will receive treatment with tobevibart + elebsiran up to 240 weeks.
Arm 2
EXPERIMENTALParticipants will receive Bulevirtide for approximately 48 weeks and switch to receive tobevibart + elebsiran for additional 192 weeks
Interventions
Eligibility Criteria
You may qualify if:
- Male or female ages 18 to 70 years at screening
- Positive HDV antibody or positive HDV RNA PCR result for at least 6 months prior to screening and HDV RNA ≥ 500 IU/mL at screening
- Noncirrhotic or compensated cirrhotic liver disease at screening
- 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
You may not qualify if:
- Serum ALT ≥ 5 × ULN
- 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 etiology
- 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 of screening with an immunomodulatory agent, immune checkpoint inhibitors, immunosuppressants, cytotoxic or chemotherapeutic agent, or chronic systemic corticosteroids.
- Any previous treatment with Bulivertide
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (31)
Investigative Site
Brussels, 1020, Belgium
Investigative Site
Brussels, 1070, Belgium
Investigative Site
Edegem, 2650, Belgium
Investigative Site
Sofia, 1407, Bulgaria
Investigative Site
Sofia, 1431, Bulgaria
Investigative Site
Stara Zagora, 6003, Bulgaria
Investigative Site
Clichy, 92110, France
Investigative Site
Créteil, 94000, France
Investigative Site
Limoges, 87042, France
Investigative Site
Rennes, 35000, France
Investigative Site
Toulouse, 31059, France
Investigative Site
Hanover, 30625, Germany
Investigative Site
Chisinau, 2025, Moldova
Investigative Site
Amsterdam, 1081 HV, Netherlands
Investigative Site
Nijmegen, 6525 GA, Netherlands
Investigative Site
Rotterdam, 3015 GD, Netherlands
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
Barcelona, 08028, Spain
Investigative Site
Madrid, 28064, Spain
Investigative
Valencia, 46014, Spain
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
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 19, 2025
First Posted
August 27, 2025
Study Start
August 5, 2025
Primary Completion (Estimated)
November 1, 2026
Study Completion (Estimated)
July 1, 2030
Last Updated
January 16, 2026
Record last verified: 2026-01