Active — Not RecruitingPhase 3

A Study to Evaluate Tobevibart + Elebsiran in Chronic HDV Infection

United States124 participantsStarted 2025-03-12

Plain-language summary

This is a multicenter, open label, randomized Phase 3 clinical study to evaluate the efficacy and safety of the combination of tobevibart + elebsiran for the treatment of chronic hepatitis delta in comparison to delayed treatment.

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
✓. Chronic HDV infection for \>/= 6 months
✓. On NRTI therapy against HBV for at least 12 weeks prior to day 1 or have HBV DNA \< 20 IU/ml at screening, currently on locally approved NRTI therapy
✓. Serum ALT \> ULN and \< 5x ULN
✓. Non-cirrhotic or Compensated Cirrhotic Liver Disease at screening

Exclusion criteria

✕. 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
✕. History or evidence of alcohol or drug abuse within 6 months before screening or a positive drug screen at screening unless it can be explained by a prescribed medication

What they're measuring

HDV RNA < Lower Limit of Quantification (LLOQ), Target Not Detected (TND) and alanine aminotransferase (ALT) normalization (ALT </= Upper Limit of Normal [ULN]) at Week 48 for Arm 1 vs at Week 12 for Arm 2

Timeframe: Up to 48 weeks

Incidence of Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) through Week 12

Timeframe: Up to 12 weeks

Trial details

NCT IDNCT06903338

SponsorVir Biotechnology, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-12-31

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