A Study to Evaluate Tobevibart + Elebsiran in Chronic HDV Infection (NCT06903338) | Clinical Trial Compass
Active — Not RecruitingPhase 3
A Study to Evaluate Tobevibart + Elebsiran in Chronic HDV Infection
United States, Canada, Georgia124 participantsStarted 2025-03-12
Plain-language 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.
Who can participate
Age range
18 Years – 70 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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
Exclusion criteria
. 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
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
Timeframe: Up to 48 weeks
2
Incidence of Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) through Week 12
. 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