A Study to Evaluate Tobevibart + Elebsiran in Chronic HDV Infection
A Phase 3 Randomized, Open-Label Study to Evaluate the Efficacy and Safety of Tobevibart + Elebsiran Combination Therapy in Participants With Chronic HDV Infection (ECLIPSE 1)
1 other identifier
interventional
124
10 countries
39
Brief Summary
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.
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 Mar 2025
Longer than P75 for phase_3
39 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
March 12, 2025
CompletedFirst Submitted
Initial submission to the registry
March 24, 2025
CompletedFirst Posted
Study publicly available on registry
March 30, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
May 1, 2031
April 8, 2026
April 1, 2026
1.8 years
March 24, 2025
April 7, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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
Secondary Outcomes (1)
HDV RNA < LLOQ, TND at Week 48 for Arm 1 vs Week 12 for Arm 2
Up to 48 weeks
Study Arms (2)
Arm 1 (Tobevibart + Elebsiran)
EXPERIMENTALParticipants will receive treatment with tobevibart + elebsiran for 240 weeks.
Arm 2 (Tobevibart + Elebsiran)
EXPERIMENTALParticipants will receive tobevibart + elebsiran after an observational period for 240 weeks.
Interventions
Tobevibart administered by subcutaneous injection
Elebsiran administered by subcutaneous injection
Eligibility Criteria
You may qualify if:
- Male or female ages 18 to 70 years at screening
- Chronic HDV infection for \>/= 6 months
- On NRTI therapy against HBV for at least 12 weeks prior to day 1 or have HBV DNA \< 20 IU/ml at screening, currently on locally approved NRTI therapy
- Serum ALT \> ULN and \< 5x ULN
- Non-cirrhotic or Compensated Cirrhotic Liver Disease at screening
You may not qualify if:
- 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
- History or evidence of alcohol or drug abuse within 6 months before screening or a positive drug screen at screening unless it can be explained by a prescribed medication
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (39)
Investigative Site
Chandler, Arizona, 85224, United States
Investigative Site
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
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
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
March 24, 2025
First Posted
March 30, 2025
Study Start
March 12, 2025
Primary Completion (Estimated)
December 31, 2026
Study Completion (Estimated)
May 1, 2031
Last Updated
April 8, 2026
Record last verified: 2026-04