Status:
ACTIVE_NOT_RECRUITING
A Study to Evaluate Tobevibart + Elebsiran in Chronic HDV Infection
Lead Sponsor:
Vir Biotechnology, Inc.
Conditions:
Viral Hepatitis
Eligibility:
All Genders
18-70 years
Phase:
PHASE3
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 co...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 12 2025
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2031
Estimated Enrollment :
124 Patients enrolled
Trial Details
Trial ID
NCT06903338
Start Date
March 12 2025
End Date
May 1 2031
Last Update
November 14 2025
Active Locations (39)
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1
Investigative Site
Chandler, Arizona, United States, 85224
2
Investigative Site
Los Angeles, California, United States, 90033
3
Investigative Site
Redwood City, California, United States, 94063
4
Investigative Site
San Francisco, California, United States, 94143