Actively Recruiting

Phase 3
Age: 18Years - 70Years
All Genders
NCT07128550

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

Led by Vir Biotechnology, Inc. · Updated on 2026-05-06

150

Participants Needed

38

Research Sites

308 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 70Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Male or female ages 18 to 70 years at screening
  • HDV RNA  500 IU/mL at screening
  • Receiving bulevirtide 2 mg subcutaneously once daily for at least 24 weeks at Day 1
  • Noncirrhotic or compensated cirrhotic liver disease at screening
  • On nucleoside reverse transcriptase inhibitor 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
Not Eligible

You will not qualify if you...

  • Serum ALT  5 times upper limit of normal
  • Any clinically significant chronic or acute medical or psychiatric condition that makes the participant unsuitable for participation
  • History of significant liver disease from non-HBV or non-HDV causes
  • History of allergic reactions, hypersensitivity, or intolerance to study drug, its metabolites, or excipients
  • History of anaphylaxis
  • History of immune complex disease
  • History of autoimmune disorder
  • Current therapy or therapy within 24 weeks prior to screening with immunomodulatory agents, immune checkpoint inhibitors, immunosuppressants, cytotoxic or chemotherapeutic agents, or chronic systemic corticosteroids

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 38 locations

1

Investigative Site

Innsbruck, Austria, 6020

Actively Recruiting

2

Investigative Site

Vienna, Austria, 1090

Actively Recruiting

3

Investigative Site

Bobigny, France, 93009

Actively Recruiting

4

Investigative Site

Clichy, France, 92110

Actively Recruiting

5

Investigative Site

Créteil, France, 94000

Actively Recruiting

6

Investigative Site

Le Chesnay, France, 78150

Actively Recruiting

7

Investigative Site

Limoges, France, 87000

Actively Recruiting

8

Investigative Site

Lyon, France, 69004

Actively Recruiting

9

Investigative Site

Montpellier, France, 34295

Actively Recruiting

10

Investigative Site

Pessac, France, 33604

Actively Recruiting

11

Investigative Site

Rennes, France, 35033

Actively Recruiting

12

Investigative Site

Toulouse, France, 31059

Actively Recruiting

13

Investigative Site

Villejuif, France, 94804

Actively Recruiting

14

Investigative Site

Berlin, Germany, 13353

Actively Recruiting

15

Investigative Site

Essen, Germany, 45147

Actively Recruiting

16

Investigative Site

Frankfurt am Main, Germany, 60590

Actively Recruiting

17

Investigative Site

Hanover, Germany, 30625

Actively Recruiting

18

Investigative Site

Bergamo, Italy, 24127

Actively Recruiting

19

Investigative Site

Foggia, Italy, 71122

Actively Recruiting

20

Investigative Site

Milan, Italy, 20089

Actively Recruiting

21

Investigative Site

Milan, Italy, 20122

Actively Recruiting

22

Investigative Site

Pisa, Italy, 56124

Actively Recruiting

23

Investigative Site

Torino, Italy, 10122

Actively Recruiting

24

Investigative Site

Torino, Italy, 10126

Actively Recruiting

25

Investigative Site

Bucharest, Romania, 021105

Actively Recruiting

26

Investigative Site

Bucharest, Romania, 022328

Actively Recruiting

27

Investigative Site

Bucharest, Romania, 030303

Actively Recruiting

28

Investigative Site

Craiova, Romania, 200073

Actively Recruiting

29

Investigative Site

Barcelona, Spain, 08035

Actively Recruiting

30

Investigative Site

Barcelona, Spain, 08036

Actively Recruiting

31

Investigative Site

Madrid, Spain, 28007

Actively Recruiting

32

Investigative Site

Madrid, Spain, 28046

Actively Recruiting

33

Investigative Site

Santander, Spain, 39008

Actively Recruiting

34

Investigative Site

London, United Kingdom, E1 1FR

Actively Recruiting

35

Investigative Site

London, United Kingdom, SE5 9NU

Actively Recruiting

36

Investigative Site

London, United Kingdom, W2 1NY

Actively Recruiting

37

Investigative Site

Manchester, United Kingdom, M8 5RB

Actively Recruiting

38

Investigative Site

Nottingham, United Kingdom, NG7 2UH

Actively Recruiting

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Research Team

S

Study Injury

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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