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Clinical Trials in the UK / NCT06903338
Active, not recruiting Phase 3

A Study to Evaluate Tobevibart + Elebsiran in Chronic HDV Infection

NCT06903338 · tracked via the Priya Life Science UK tracker
Sponsor
Vir Biotechnology, Inc.
Phase
Phase 3
Started
2025-03-12
Last updated
2026-04-08

Condition(s) studied

Viral Hepatitis

Investigational drug(s) / intervention(s)

TobevibartElebsiran

Tobevibart: Tobevibart administered by subcutaneous injection

Elebsiran: Elebsiran administered by subcutaneous injection

Study 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.

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. Chronic HDV infection for \>/= 6 months 3. 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 4. Serum ALT \> ULN and \< 5x ULN 5. Non-cirrhotic or Compensated Cirrhotic Liver Disease at screening Exclusion Criteria: 1. Any clinically significant chronic or acute medical or psychiatric condition that makes the participant unsuitable for participation. 2. History of significant liver disease from non-HBV or non-HDV etiology 3. History of allergic reactions, hypersensitivity, or intolerance to study drug, its metabolites, or excipients. 4. History of anaphylaxis 5. History of immune complex disease 6. History of autoimmune disorder 7. 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

Primary outcome measure(s)

Trial sites (39)

FacilityCityRegionStatus
Investigative Site Chandler Arizona
Investigative Site Los Angeles California
Investigative Site Redwood City California
Investigative Site San Francisco California
Investigative Site DeLand Florida
Investigative Site Chicago Illinois
Investigative Site Baltimore Maryland
Investigative Site Hillsborough New Jersey
Investigative Site New York New York
Investigative Site New York New York
Investigative Site New York New York
Investigative Site Murray Utah
Investigative Site Seattle Washington
Investigative Site Calgary Alberta
Investigative Site Montreal Quebec
Investigative Site Montreal Canada
Investigative Site Ottawa Canada
Investigative Site Québec Canada
Investigative Site Vancouver Canada
Investigative Site Tbilisi Georgia
Investigative Site Tbilisi Georgia
Investigative Site Tbilisi Georgia
Investigative Site Frankfurt Germany
Investigative Site Hanover Germany
Investigative Site Heidelberg Germany
Investigative Site Chisinau Moldova
Investigative Site Auckland New Zealand
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 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 the UK

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 NCT06903338 on ClinicalTrials.gov ↗ ← All trials in the UK