A Study to Evaluate Tobevibart + Elebsiran in Chronic HDV Infection

Running, not enrolling · Phase 3

Conditions studied: Viral Hepatitis

In brief

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.

Key facts

Study ID

NCT06903338

Run by

Vir Biotechnology, Inc.

People needed

124

Starts

2025-03-12

Expected to finish

2031-05-01

Last updated by the study team

2026-04-08

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

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

Where it is running

• 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

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.