RecruitingPhase 3

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

Austria, France150 participantsStarted 2025-07-30

Plain-language 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

Who can participate

Age range18 Years – 70 Years

SexALL

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Inclusion criteria

✓. Male or female ages 18 to 70 years at screening
✓. HDV RNA ≥ 500 IU/mL at screening
✓. Receiving BLV 2 mg SC QD for ≥ 24 weeks at Day 1
✓. Noncirrhotic or compensated cirrhotic liver disease at screening
✓. On NRTI therapy against HBV for at least 12 weeks prior to day 1 or have HBV DNA \< 10 IU/ml at screening, currently on locally approved NRTI therapy

Exclusion criteria

✕. Serum ALT ≥ 5 × ULN
✕. Any clinically significant chronic or acute medical or psychiatric condition that makes the participant unsuitable for participation.
✕. History of significant liver disease from non-HBV or non-HDV etiology
✕. History of allergic reactions, hypersensitivity, or intolerance to study drug, its metabolites, or excipients.
✕. History of anaphylaxis
✕. History of immune complex disease
✕. History of autoimmune disorder
✕. Current therapy or therapy within 24 weeks of screening with an immunomodulatory agent, immune checkpoint inhibitors, immunosuppressants, cytotoxic or chemotherapeutic agent, or chronic systemic corticosteroids.

What they're measuring

HDV RNA < Lower Limit of Quantification (LLOQ), Target not detected (TND) at Week 24

Timeframe: Week 24

HDV RNA < Lower Limit of Quantification (LLOQ), Target not detected (TND) 24 weeks after end of treatment.

Timeframe: 24 Weeks after End of Treatment

Trial details

NCT IDNCT07128550

SponsorVir Biotechnology, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-12

Contact for this trial

Study Injury

415-654-5281 clinicaltrials@vir.bio

View on ClinicalTrials.gov More Viral Hepatitis trials