VIR-CHDV-V205 (ECLIPSE-2)

• Research type

  Research Study

• Full title

  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)

• IRAS ID

  1011573

• Contact name

  Study Inquiry

• Contact email

  clinicaltrials@vir.bio

• Sponsor organisation

  Vir Biotechnology, Inc.

• Research summary

  The ECLIPSE-2 research study is being done to learn more about chronic (long-term) hepatitis Delta virus (HDV) infection and if the combination of research study drugs, tobevibart (VIR-3434) and elebsiran (VIR-2218), can treat this infection and how they compare to bulevirtide (BLV), in people with chronic HDV infection. We also want to know:
  • Are the study drugs safe?
  • Can the study drugs normalise liver function tests?
  • How do the study drugs affect liver stiffness?
  • Do the study drugs cause any side effects?
  • How do the study drugs interact with the body?
  • Can the study drugs reduce levels of HDV particles in the body?
  • How much and what amount of each study drug stays in the blood over time?
  There are two treatment groups for this study:
  • Arm 1 will receive tobevibart (300mg) + elebsiran (200mg) every 4 weeks for up to 240 weeks.
  • Arm 2 will continue to administer bulevirtide (BLV) (2 mg) daily for up to 24 weeks, after which participants will stop BLV treatment and instead receive tobevibart (300mg) + elebsiran (200mg) every 4 weeks for up to 216 weeks.
  HDV is a virus that infects your liver. Persons with HDV infection may develop cirrhosis (excessive accumulation of liver scars), end-stage liver disease (inability of the liver to make necessary proteins and detoxify the blood), and liver cancer. Tobevibart and elebsiran are experimental drugs. An experimental drug is a medication that is still being studied and has not yet been approved by the Medicines and Healthcare products Regulatory Agency (MHRA) in the UK as safe and effective and is considered an experimental treatment. MHRA allows tobevibart and elebsiran to be used only in research. The study will include approximately 150 participants. The total study duration for each participant is planned to be up to 270 weeks. This includes a 6-week screening period, followed by up to 240 weeks of the study intervention period, and a 24-week follow-up period.

• REC name

  London - Brent Research Ethics Committee

• REC reference

  25/LO/0194

• Date of REC Opinion

  4 Jun 2025

• REC opinion

  Further Information Favourable Opinion