A Study to Evaluate Tobevibart+Elebsiran in Participants With Chronic HDV Infection Not Virologically Suppressed With Bulevirtide
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)
1 other identifier
interventional
150
7 countries
38
Brief 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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Jul 2025
Longer than P75 for phase_3
38 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 30, 2025
CompletedFirst Submitted
Initial submission to the registry
August 13, 2025
CompletedFirst Posted
Study publicly available on registry
August 19, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
July 1, 2031
May 6, 2026
May 1, 2026
1.3 years
August 13, 2025
May 4, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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 (3)
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
Study Arms (2)
Arm 1
EXPERIMENTALParticipants will receive treatment with tobevibart + elebsiran up to 240 weeks.
Arm 2
EXPERIMENTALParticipants will receive Bulevirtide for 24 weeks and switch to receive tobevibart + elebsiran for additional 216 weeks
Interventions
Eligibility Criteria
You may qualify if:
- Male or female ages 18 to 70 years at screening
- HDV RNA ≥ 500 IU/mL at screening
- Receiving BLV 2 mg SC QD for ≥ 24 weeks at Day 1
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (38)
Investigative Site
Innsbruck, 6020, Austria
Investigative Site
Vienna, 1090, Austria
Investigative Site
Bobigny, 93009, France
Investigative Site
Clichy, 92110, France
Investigative Site
Créteil, 94000, France
Investigative Site
Le Chesnay, 78150, France
Investigative Site
Limoges, 87000, France
Investigative Site
Lyon, 69004, France
Investigative Site
Montpellier, 34295, France
Investigative Site
Pessac, 33604, France
Investigative Site
Rennes, 35033, France
Investigative Site
Toulouse, 31059, France
Investigative Site
Villejuif, 94804, France
Investigative Site
Berlin, 13353, Germany
Investigative Site
Essen, 45147, Germany
Investigative Site
Frankfurt am Main, 60590, Germany
Investigative Site
Hanover, 30625, Germany
Investigative Site
Bergamo, 24127, Italy
Investigative Site
Foggia, 71122, Italy
Investigative Site
Milan, 20089, Italy
Investigative Site
Milan, 20122, Italy
Investigative Site
Pisa, 56124, Italy
Investigative Site
Torino, 10122, Italy
Investigative Site
Torino, 10126, Italy
Investigative Site
Bucharest, 021105, Romania
Investigative Site
Bucharest, 022328, Romania
Investigative Site
Bucharest, 030303, Romania
Investigative Site
Craiova, 200073, Romania
Investigative Site
Barcelona, 08035, Spain
Investigative Site
Barcelona, 08036, Spain
Investigative Site
Madrid, 28007, Spain
Investigative Site
Madrid, 28046, Spain
Investigative Site
Santander, 39008, Spain
Investigative Site
London, E1 1FR, United Kingdom
Investigative Site
London, SE5 9NU, United Kingdom
Investigative Site
London, W2 1NY, United Kingdom
Investigative Site
Manchester, M8 5RB, United Kingdom
Investigative Site
Nottingham, NG7 2UH, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 13, 2025
First Posted
August 19, 2025
Study Start
July 30, 2025
Primary Completion (Estimated)
December 1, 2026
Study Completion (Estimated)
July 1, 2031
Last Updated
May 6, 2026
Record last verified: 2026-05