A Phase 3 Randomized, Open-Label Study to Evaluate the Efficacy and Safety of Tobevibart + Elebsiran Combination Therapy in Participants With Chronic HDV Infection (ECLIPSE 1)
Status: Recruiting
Location: See all (39) 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 the efficacy and safety of the combination of tobevibart + elebsiran for the treatment of chronic hepatitis delta in comparison to delayed treatment.
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
• 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
Locations
United States
Arizona
Investigative Site
RECRUITING
Chandler
California
Investigative Site
RECRUITING
Los Angeles
Investigative Site
RECRUITING
Redwood City
Investigative Site
RECRUITING
San Francisco
Florida
Investigative Site
RECRUITING
Deland
Illinois
Investigative Site
RECRUITING
Chicago
Maryland
Investigative Site
RECRUITING
Baltimore
New Jersey
Investigative Site
RECRUITING
Hillsborough
New York
Investigative Site
RECRUITING
New York
Investigative Site
RECRUITING
New York
Investigative Site
RECRUITING
New York
Utah
Investigative Site
RECRUITING
Murray
Washington
Investigative Site
RECRUITING
Seattle
Other Locations
Canada
Investigative Site
RECRUITING
Calgary
Investigative Site
RECRUITING
Montreal
Investigative Site
RECRUITING
Montreal
Investigative Site
RECRUITING
Ottawa
Investigative Site
RECRUITING
Québec
Investigative Site
RECRUITING
Vancouver
Georgia
Investigative Site
RECRUITING
Tbilisi
Investigative Site
RECRUITING
Tbilisi
Investigative Site
RECRUITING
Tbilisi
Germany
Investigative Site
RECRUITING
Frankfurt
Investigative Site
RECRUITING
Hanover
Investigative Site
RECRUITING
Heidelberg
New Zealand
Investigative Site
RECRUITING
Auckland
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
Ukraine
Investigative Site
RECRUITING
Kyiv
United Kingdom
Investigative Site
RECRUITING
London
Investigative Site
RECRUITING
London
Investigative Site
RECRUITING
Manchester
Investigative Site
RECRUITING
Nottingham
Contact Information
Primary
Study Inquiry
clinicaltrials@vir.bio
415-654-5281
Time Frame
Start Date: 2025-03-12
Estimated Completion Date: 2031-05
Participants
Target number of participants: 120
Treatments
Experimental: Arm 1 (Tobevibart + Elebsiran)
Participants will receive treatment with tobevibart + elebsiran for 240 weeks.
Experimental: Arm 2 (Tobevibart + Elebsiran)
Participants will receive tobevibart + elebsiran after an observational period for 240 weeks.
Related Therapeutic Areas
Sponsors
Leads: Vir Biotechnology, Inc.