A Study to Evaluate Tobevibart + Elebsiran in Chronic HDV Infection
NCT ID: NCT06903338
Last Updated: 2025-11-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
ACTIVE_NOT_RECRUITING
PHASE3
124 participants
INTERVENTIONAL
2025-03-12
2031-05-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
A Study to Evaluate Tobevibart+Elebsiran in Participants With Chronic HDV Infection Not Virologically Suppressed With Bulevirtide
NCT07128550
A Study to Evaluate Tobevibart+Elebsiran Versus Bulevirtide in Chronic HDV Infection
NCT07142811
Study of Bepirovirsen in Nucleos(t)Ide Analogue-treated Participants With Chronic Hepatitis B (B-Well 1)
NCT05630807
A Study of GSK3228836 in Participants With Chronic Hepatitis B (CHB)
NCT04449029
Efficacy and Safety Study of Entecavir Plus Tenofovir in Patients With Chronic Hepatitis B Who Failed Previous Treatment
NCT01063036
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Arm 1 (Tobevibart + Elebsiran)
Participants will receive treatment with tobevibart + elebsiran for 240 weeks.
Tobevibart
Tobevibart administered by subcutaneous injection
Elebsiran
Elebsiran administered by subcutaneous injection
Arm 2 (Tobevibart + Elebsiran)
Participants will receive tobevibart + elebsiran after an observational period for 240 weeks.
Tobevibart
Tobevibart administered by subcutaneous injection
Elebsiran
Elebsiran administered by subcutaneous injection
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Tobevibart
Tobevibart administered by subcutaneous injection
Elebsiran
Elebsiran administered by subcutaneous injection
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. Chronic HDV infection for \>/= 6 months
3. 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
4. Serum ALT \> ULN and \< 5x ULN
5. Non-cirrhotic or Compensated Cirrhotic Liver Disease at screening
Exclusion Criteria
2. History of significant liver disease from non-HBV or non-HDV etiology
3. History of allergic reactions, hypersensitivity, or intolerance to study drug, its metabolites, or excipients.
4. History of anaphylaxis
5. History of immune complex disease
6. History of autoimmune disorder
7. 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
18 Years
70 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Vir Biotechnology, Inc.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Investigative Site
Chandler, Arizona, United States
Investigative Site
Los Angeles, California, United States
Investigative Site
Redwood City, California, United States
Investigative Site
San Francisco, California, United States
Investigative Site
DeLand, Florida, United States
Investigative Site
Chicago, Illinois, United States
Investigative Site
Baltimore, Maryland, United States
Investigative Site
Hillsborough, New Jersey, United States
Investigative Site
New York, New York, United States
Investigative Site
New York, New York, United States
Investigative Site
New York, New York, United States
Investigative Site
Murray, Utah, United States
Investigative Site
Seattle, Washington, United States
Investigative Site
Calgary, Alberta, Canada
Investigative Site
Montreal, Quebec, Canada
Investigative Site
Montreal, , Canada
Investigative Site
Ottawa, , Canada
Investigative Site
Québec, , Canada
Investigative Site
Vancouver, , Canada
Investigative Site
Tbilisi, , Georgia
Investigative Site
Tbilisi, , Georgia
Investigative Site
Tbilisi, , Georgia
Investigative Site
Frankfurt, , Germany
Investigative Site
Hanover, , Germany
Investigative Site
Heidelberg, , Germany
Investigative Site
Chisinau, , Moldova
Investigative Site
Auckland, , New Zealand
Investigative Site
Karachi, , Pakistan
Investigative Site
Karachi, , Pakistan
Investigative Site
Lahore, , Pakistan
Investigative Site
Rawalpindi, , Pakistan
Investigative Site
Bucharest, , Romania
Investigative Site
Bucharest, , Romania
Investigative Site
Bucharest, , Romania
Investigative Site
Kyiv, , Ukraine
Investigative Site
London, , United Kingdom
Investigative Site
London, , United Kingdom
Investigative Site
Manchester, , United Kingdom
Investigative Site
Nottingham, , United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
VIR-CHDV-V203
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.