Language: BG BG
← Back to results
Active (not recruiting) Phase 3 NCT06903338

A Study to Evaluate Tobevibart + Elebsiran in Chronic HDV Infection

Phase 3 – large-scale trial before approval
Conditions: Viral Hepatitis

Sponsor: Vir Biotechnology, Inc.

trial.available_in: БГ
Overview
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.
Who can participate
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
Locations 10
Canada (1)
Investigative Site
Calgary , Alberta
Georgia (1)
Investigative Site
Tbilisi
Germany (1)
Investigative Site
Frankfurt
Moldova (1)
Investigative Site
Chisinau
New Zealand (1)
Investigative Site
Auckland
Pakistan (1)
Investigative Site
Karachi
Romania (1)
Investigative Site
Bucharest
Ukraine (1)
Investigative Site
Kyiv
United Kingdom (1)
Investigative Site
London
United States (1)
Investigative Site
Chandler , Arizona
Technical details
Status
Active (not recruiting)
Phase
Phase 3
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
18 Years
Maximum age
70 Years
Healthy volunteers
No
Start date
12.03.2025
Completion date
01.05.2031
Registry ID
NCT06903338
Source
anzctr
trial.inquiry_btn

Information is automatically extracted from ClinicalTrials.gov. Consult your doctor before taking action.