Active — Not RecruitingPhase 2

A Study to Evaluate Tobevibart+Elebsiran Versus Bulevirtide in Chronic HDV Infection

Belgium, Bulgaria100 participantsStarted 2025-08-05

Plain-language summary

A Study to Evaluate Tobevibart+Elebsiran versus Bulevirtide in Chronic HDV Infection

Age range18 Years – 70 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. Male or female ages 18 to 70 years at screening
✓. Positive HDV antibody or positive HDV RNA PCR result for at least 6 months prior to screening and HDV RNA ≥ 500 IU/mL at screening
✓. 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

✕. 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.

HDV RNA < Lower Limit of Quantification (LLOQ), Target not detected (TND) at Week 48

Timeframe: Week 48

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

Timeframe: 24 Weeks after End of Treatment

Incidence of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) through Week 48

Timeframe: Week 48

NCT IDNCT07142811

SponsorVir Biotechnology, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-11

Who can participate

Age range18 Years – 70 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. Male or female ages 18 to 70 years at screening
✓. Positive HDV antibody or positive HDV RNA PCR result for at least 6 months prior to screening and HDV RNA ≥ 500 IU/mL at screening
✓. 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

✕. 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 48

Timeframe: Week 48

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

Timeframe: 24 Weeks after End of Treatment

Incidence of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) through Week 48

Timeframe: Week 48