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Active, not recruiting Phase 2

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

NCT07142811 · tracked via the Priya Life Science France tracker
Phase
Phase 2
Started
2025-08-05
Last updated
2026-01-16

Condition(s) studied

Viral Hepatitis

Investigational drug(s) / intervention(s)

Tobevibart →Elebsiran →Bulevirtide →

Tobevibart: Tobevibart administered by subcutaneous injection

Elebsiran: Elebsiran administered by subcutaneous injection

Bulevirtide: Bulevirtide administered by subcutaneous injection

Study summary

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

Eligibility

Sex
ALL
Min age
18 Years
Max age
70 Years
Healthy volunteers
No
Inclusion Criteria: 1. Male or female ages 18 to 70 years at screening 2. 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 3. Noncirrhotic or compensated cirrhotic liver disease at screening 4. 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: 1. Serum ALT ≥ 5 × ULN 2. Any clinically significant chronic or acute medical or psychiatric condition that makes the participant unsuitable for participation. 3. History of significant liver disease from non-HBV or non-HDV etiology 4. History of allergic reactions, hypersensitivity, or intolerance to study drug, its metabolites, or excipients. 5. History of anaphylaxis 6. History of immune complex disease 7. History of autoimmune disorder 8. 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. 9. Any previous treatment with Bulivertide

Primary outcome measure(s)

  • HDV RNA < Lower Limit of Quantification (LLOQ), Target not detected (TND) at Week 48 — Week 48
  • HDV RNA < Lower Limit of Quantification (LLOQ), Target not detected (TND) 24 weeks after end of treatment — 24 Weeks after End of Treatment
  • Incidence of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) through Week 48 — Week 48

Trial sites (31)

FacilityCityRegionStatus
Investigative Site Brussels Belgium
Investigative Site Brussels Belgium
Investigative Site Edegem Belgium
Investigative Site Sofia Bulgaria
Investigative Site Sofia Bulgaria
Investigative Site Stara Zagora Bulgaria
Investigative Site Clichy France
Investigative Site Créteil France
Investigative Site Limoges France
Investigative Site Rennes France
Investigative Site Toulouse France
Investigative Site Hanover Germany
Investigative Site Chisinau Moldova
Investigative Site Amsterdam Netherlands
Investigative Site Nijmegen Netherlands
Investigative Site Rotterdam Netherlands
Investigative Site Karachi Pakistan
Investigative Site Karachi Pakistan
Investigative Site Lahore Pakistan
Investigative Site Rawalpindi Pakistan
Investigative Site Bucharest Romania
Investigative Site Bucharest Romania
Investigative Site Bucharest Romania
Investigative Site Barcelona Spain
Investigative Site Madrid Spain
Investigative Valencia Spain
Investigative Site Kyiv Ukraine
Investigative Site London United Kingdom
Investigative Site London United Kingdom
Investigative Site Manchester United Kingdom
Investigative Site Nottingham United Kingdom
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07142811 on ClinicalTrials.gov ↗ ← All trials in France