A Study to Evaluate Tobevibart + Elebsiran in Chronic HDV Infection

Launched by VIR BIOTECHNOLOGY, INC. · Mar 24, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a combination of two medications, tobevibart and elebsiran, to see how effective and safe they are for treating chronic hepatitis delta (HDV infection). The trial is open to both men and women aged 18 to 70 who have had chronic HDV infection for at least six months. Participants should also be on a specific type of treatment for hepatitis B virus (HBV) and have liver function tests that meet certain criteria.

If you join this study, you will receive one of the treatments, either the combination of the two drugs or a delayed treatment option, and you will be monitored closely by healthcare professionals. The trial aims to find out if this new treatment can help improve your condition compared to waiting for treatment. It’s important to know that not everyone can participate; there are specific health conditions that may exclude you from the study, such as serious liver diseases unrelated to hepatitis or certain allergies. Overall, this trial represents a chance to explore a new potential treatment for those living with chronic HDV infection.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Male or female ages 18 to 70 years at screening
• • 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:
• • 1. Any clinically significant chronic or acute medical or psychiatric condition that makes the participant unsuitable for participation.
• • 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