Status:
RECRUITING
A Study to Evaluate Tobevibart+Elebsiran Versus Bulevirtide in Chronic HDV Infection
Lead Sponsor:
Vir Biotechnology, Inc.
Conditions:
Viral Hepatitis
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
Brief Summary
A Study to Evaluate Tobevibart+Elebsiran versus Bulevirtide in Chronic HDV Infection
Eligibility Criteria
Inclusion
- Male or female ages 18 to 70 years at screening
- Positive HDV antibody or positive HDV RNA PCR result for at least 6 months prior to screening and HDV RNA ≥ 500 IU/mL at screening
- Noncirrhotic or compensated cirrhotic liver disease at screening
- 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
Exclusion
- Serum ALT ≥ 5 × ULN
- 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
- Current therapy or therapy within 24 weeks of screening with an immunomodulatory agent, immune checkpoint inhibitors, immunosuppressants, cytotoxic or chemotherapeutic agent, or chronic systemic corticosteroids.
- Any previous treatment with Bulivertide
Key Trial Info
Start Date :
August 5 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2031
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT07142811
Start Date
August 5 2025
End Date
April 1 2031
Last Update
November 12 2025
Active Locations (31)
Enter a location and click search to find clinical trials sorted by distance.
1
Investigative Site
Brussels, Belgium, 1020
2
Investigative Site
Brussels, Belgium, 1070
3
Investigative Site
Edegem, Belgium, 2650
4
Investigative Site
Sofia, Bulgaria, 1407