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)

What this Trial Is About

Researchers are evaluating the combination of tobevibart and elebsiran in adults aged 18 to 70 years with chronic Hepatitis D Virus (HDV) infection who have not achieved viral suppression with bulevirtide treatment. This Phase 3, randomized, open-label trial aims to assess the efficacy and safety of this combination therapy for participants who continue to have active HDV infection despite prior treatment with bulevirtide. The study is sponsored by Vir Biotechnology, Inc. and addresses a critical need for improved therapeutic options in this population. Participants will be assigned to one of two groups. One group will receive tobevibart plus elebsiran together for up to 240 weeks. The second group will continue bulevirtide treatment for 24 weeks before switching to the combination of tobevibart and elebsiran for the remaining 216 weeks. All drugs are given by subcutaneous injection. This design allows comparison of continued bulevirtide versus switching to the new combination therapy over a long-term period. During the study, participants will have their HDV RNA levels measured at multiple time points, including week 24, and up to 24 weeks after treatment ends, to evaluate viral suppression. Researchers will also monitor liver enzyme changes and record any treatment-related side effects through week 240. Safety assessments and laboratory tests will be conducted regularly throughout the study. The total duration for individual participation may be up to approximately 4.5 years, including extended follow-up to assess long-term outcomes and safety.

A Study to Evaluate Tobevibart+Elebsiran in Participants With Chronic HDV Infection Not Virologically Suppressed With Bulevirtide