Clinical Trials in France / NCT07142811
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
Condition(s) studied
Viral Hepatitis
Investigational drug(s) / intervention(s)
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
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)
| Facility | City | Region | Status |
|---|---|---|---|
| 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 |
More Vir Biotechnology, Inc. trials in France
Other trials for the same condition
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