A Phase 2b Randomized, Open-Label Study to Evaluate the Efficacy and Safety of Tobevibart+Elebsiran Combination Therapy Versus Bulevirtide in Participants With Chronic HDV Infection (ECLIPSE 3)
Status: Recruiting
Location: See all (26) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY
A Study to Evaluate Tobevibart+Elebsiran versus Bulevirtide in Chronic HDV Infection
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 70
Healthy Volunteers: f
View:
• 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
Locations
Other Locations
Belgium
Investigative Site
RECRUITING
Brussels
Investigative Site
RECRUITING
Edegem
Bulgaria
Investigative Site
RECRUITING
Sofia
Investigative Site
RECRUITING
Sofia
Investigative Site
RECRUITING
Stara Zagora
France
Investigative Site
RECRUITING
Clichy
Investigative Site
RECRUITING
Limoges
Investigative Site
RECRUITING
Rennes
Investigative Site
RECRUITING
Toulouse
Germany
Investigative Site
RECRUITING
Hanover
Netherlands
Investigative Site
RECRUITING
Amsterdam
Investigative Site
RECRUITING
Nijmegen
Investigative Site
RECRUITING
Rotterdam
Pakistan
Investigative Site
RECRUITING
Karachi
Investigative Site
RECRUITING
Karachi
Investigative Site
RECRUITING
Lahore
Investigative Site
RECRUITING
Rawalpindi
Republic of Moldova
Investigative Site
RECRUITING
Chisinau
Romania
Investigative Site
RECRUITING
Bucharest
Investigative Site
RECRUITING
Bucharest
Investigative Site
RECRUITING
Bucharest
Spain
Investigative Site
RECRUITING
Barcelona
Ukraine
Investigative Site
RECRUITING
Kyiv
United Kingdom
Investigative Site
RECRUITING
London
Investigative Site
RECRUITING
London
Investigative Site
RECRUITING
Nottingham
Contact Information
Primary
Study Inquiry
clinicaltrials@vir.bio
415-654-5281
Time Frame
Start Date: 2025-08-05
Estimated Completion Date: 2031-04
Participants
Target number of participants: 100
Treatments
Experimental: Arm 1
Participants will receive treatment with tobevibart + elebsiran up to 240 weeks.
Experimental: Arm 2
Participants will receive Bulevirtide for approximately 48 weeks and switch to receive tobevibart + elebsiran for additional 192 weeks
Related Therapeutic Areas
Sponsors
Leads: Vir Biotechnology, Inc.