A Phase 3 Randomized, Open-Label Study to Evaluate the Efficacy and Safety of Tobevibart+Elebsiran Combination Therapy in Participants With Chronic HDV Infection Not Virologically Suppressed With Bulevirtide (ECLIPSE 2)
Status: Recruiting
Location: See all (20) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY
This is a multicenter, open label, randomized Phase 3 clinical study to evaluate tobevibart + elebsiran in participants with Chronic HDV Infection not virologically suppressed with bulevirtide
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
• HDV RNA ≥ 500 IU/mL at screening
• Receiving BLV 2 mg SC QD for ≥ 24 weeks at Day 1
• 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 \< 10 IU/ml at screening, currently on locally approved NRTI therapy
Locations
Other Locations
France
Investigative Site
RECRUITING
Bobigny
Investigative Site
RECRUITING
Clichy
Investigative Site
RECRUITING
Le Chesnay
Investigative Site
RECRUITING
Limoges
Investigative Site
RECRUITING
Lyon
Investigative Site
RECRUITING
Pessac
Investigative Site
RECRUITING
Rennes
Investigative Site
RECRUITING
Toulouse
Investigative Site
RECRUITING
Villejuif
Germany
Investigative Site
RECRUITING
Frankfurt Am Main
Investigative Site
RECRUITING
Hanover
Romania
Investigative Site
RECRUITING
Bucharest
Investigative Site
RECRUITING
Bucharest
Investigative Site
RECRUITING
Bucharest
Investigative Site
RECRUITING
Craiova
Spain
Investigative Site
RECRUITING
Barcelona
Investigative Site
RECRUITING
Santander
United Kingdom
Investigative Site
RECRUITING
London
Investigative Site
RECRUITING
London
Investigative Site
RECRUITING
Nottingham
Contact Information
Primary
Study Injury
clinicaltrials@vir.bio
415-654-5281
Time Frame
Start Date: 2025-07-30
Estimated Completion Date: 2031-07
Participants
Target number of participants: 150
Treatments
Experimental: Arm 1
Participants will receive treatment with tobevibart + elebsiran up to 240 weeks.
Experimental: Arm 2
Participants will receive Bulevirtide for 24 weeks and switch to receive tobevibart + elebsiran for additional 216 weeks
Related Therapeutic Areas
Sponsors
Leads: Vir Biotechnology, Inc.