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Active, not recruiting Phase 3

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

NCT07128550 · tracked via the Priya Life Science UK tracker
Phase
Phase 3
Started
2025-07-30
Last updated
2026-07-13

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

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

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. HDV RNA ≥ 500 IU/mL at screening 3. Receiving BLV 2 mg SC QD for ≥ 24 weeks at Day 1 4. Noncirrhotic or compensated cirrhotic liver disease at screening 5. 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.

Primary outcome measure(s)

  • HDV RNA < Lower Limit of Quantification (LLOQ), Target not detected (TND) at Week 24 — Week 24
  • HDV RNA < Lower Limit of Quantification (LLOQ), Target not detected (TND) 24 weeks after end of treatment. — 24 Weeks after End of Treatment

Trial sites (38)

FacilityCityRegionStatus
Investigative Site Innsbruck Austria
Investigative Site Vienna Austria
Investigative Site Bobigny France
Investigative Site Clichy France
Investigative Site Créteil France
Investigative Site Le Chesnay France
Investigative Site Limoges France
Investigative Site Lyon France
Investigative Site Montpellier France
Investigative Site Pessac France
Investigative Site Rennes France
Investigative Site Toulouse France
Investigative Site Villejuif France
Investigative Site Berlin Germany
Investigative Site Essen Germany
Investigative Site Frankfurt am Main Germany
Investigative Site Hanover Germany
Investigative Site Bergamo Italy
Investigative Site Foggia Italy
Investigative Site Milan Italy
Investigative Site Milan Italy
Investigative Site Pisa Italy
Investigative Site Torino Italy
Investigative Site Torino Italy
Investigative Site Bucharest Romania
Investigative Site Bucharest Romania
Investigative Site Bucharest Romania
Investigative Site Craiova Romania
Investigative Site Barcelona Spain
Investigative Site Barcelona Spain
Investigative Site Madrid Spain
Investigative Site Madrid Spain
Investigative Site Santander Spain
Investigative Site London United Kingdom
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 NCT07128550 on ClinicalTrials.gov ↗ ← All trials in the UK