VIR-CHDV-V206 ECLIPSE 3
Research type
Research Study
Full title
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)
IRAS ID
1011832
Contact name
Amy Rock
Contact email
Sponsor organisation
Vir Biotechnology, Inc
Research summary
This is a Phase 2b clinical trial which means the effectiveness and safety of new treatments are being tested in participants with a condition or disease. This trial will include adult participants with chronic HDV (hepatitis D virus) infection. The trial will be conducted in different countries around the world. Participants will be randomly divided and assigned treatment so for every 3 people enrolled in to the trial, 2 will receive tobevibart+elebsiran (Arm 1) and 1 will receive Bulevirtide (BLV) (Arm 2). Participants will be divided based on whether they have no cirrhosis or compensated cirrhosis and whether they have normal or abnormal liver enzyme levels. Part 1 of the trial will test the effectiveness and safety of tobevibart (300 mg) + elebsiran (200 mg) every 4 weeks compared with BLV daily treatment. Participants in Arm 1 will receive tobevibart+elebsiran for 96 weeks. Participants in Arm 2 will stop taking BLV at Week 48 or earlier and begin taking tobevibart+elebsiran for the duration of the study (total of at least 192 weeks). Both participants and doctors will know who was given which treatment (known as an open-label trial). Part 2 of the trial will study the effectiveness of tobevibart+elebsiran in keeping HDV RNA (hepatitis D virus ribonucleic acid) very low (too low to accurately measure) and undetectable after systematic treatment interruption. Participants in Arm 1 who reach and maintain undetectable levels of HDV RNA during the trial will interrupt tobevibart+elebsiran treatment starting at Week 96. Participants in Arm 1 who do not reach undetectable levels of HDV RNA and all participants in Arm 2 will continue to receive tobevibart+elebsiran until the end of the trial. Safety of tobevibart+elebsiran and BLV will be studied in both parts. Participants in both arms will be in the trial for up to 270 weeks in total.
REC name
London - Brighton & Sussex Research Ethics Committee
REC reference
25/LO/0254
Date of REC Opinion
1 Jul 2025
REC opinion
Further Information Favourable Opinion