RecruitingPhase 3NCT07128550

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

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)

Sponsor

Vir Biotechnology, Inc.

Enrollment

150 participants

Start Date

Jul 30, 2025

Study Type

INTERVENTIONAL

Conditions

Viral Hepatitis

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

Min Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This Phase 3 trial tests a combination of two investigational drugs — tobevibart and elebsiran — in adults with chronic hepatitis D virus (HDV) infection whose virus levels have not been adequately suppressed by the standard treatment, bulevirtide. HDV is a serious liver infection that only affects people who also have hepatitis B, and it can lead to rapid liver deterioration. Eligible participants are adults aged 18–70 with detectable HDV levels despite at least 24 weeks of bulevirtide treatment, compensated liver disease, and ongoing hepatitis B antiviral therapy. Participation involves receiving the combination drug regimen and undergoing regular blood tests to monitor viral load, liver function, and safety over the study period. This summary was prepared to help patients understand the study in plain language.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGTobevibart

Tobevibart administered by subcutaneous injection

DRUGElebsiran

Elebsiran administered by subcutaneous injection

DRUGBulevirtide

Bulevirtide administered by subcutaneous injection

Locations(38)

Investigative Site

Innsbruck, Austria

Investigative Site

Vienna, Austria

Investigative Site

Bobigny, France

Investigative Site

Clichy, France

Investigative Site

Créteil, France

Investigative Site

Le Chesnay, France

Investigative Site

Limoges, France

Investigative Site

Lyon, France

Investigative Site

Montpellier, France

Investigative Site

Pessac, France

Investigative Site

Rennes, France

Investigative Site

Toulouse, France

Investigative Site

Villejuif, France

Investigative Site

Berlin, Germany

Investigative Site

Essen, Germany

Investigative Site

Frankfurt am Main, Germany

Investigative Site

Hanover, Germany

Investigative Site

Bergamo, Italy

Investigative Site

Foggia, Italy

Investigative Site

Milan, Italy

Investigative Site

Milan, Italy

Investigative Site

Pisa, Italy

Investigative Site

Torino, Italy

Investigative Site

Torino, Italy

Investigative Site

Bucharest, Romania

Investigative Site

Bucharest, Romania

Investigative Site

Bucharest, Romania

Investigative Site

Craiova, Romania

Investigative Site

Barcelona, Spain

Investigative Site

Barcelona, Spain

Investigative Site

Madrid, Spain

Investigative Site

Madrid, Spain

Investigative Site

Santander, Spain

Investigative Site

London, United Kingdom

Investigative Site

London, United Kingdom

Investigative Site

London, United Kingdom

Investigative Site

Manchester, United Kingdom

Investigative Site

Nottingham, United Kingdom

View Full Details on ClinicalTrials.gov

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NCT07128550

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