A Study to Evaluate Tobevibart + Elebsiran in Chronic HDV Infection

Purpose

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.

Condition

  • Viral Hepatitis

Eligibility

Eligible Ages
Between 18 Years and 70 Years
Eligible Genders
All
Accepts 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

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Arm 1 (Tobevibart + Elebsiran) 		Participants will receive treatment with tobevibart + elebsiran for 240 weeks.
  • Drug: Tobevibart
    Tobevibart administered by subcutaneous injection
    Other names:
    • VIR-3434
  • Drug: Elebsiran
    Elebsiran administered by subcutaneous injection
    Other names:
    • VIR-2218
Experimental
Arm 2 (Tobevibart + Elebsiran) 		Participants will receive tobevibart + elebsiran after an observational period for 240 weeks.
  • Drug: Tobevibart
    Tobevibart administered by subcutaneous injection
    Other names:
    • VIR-3434
  • Drug: Elebsiran
    Elebsiran administered by subcutaneous injection
    Other names:
    • VIR-2218

Recruiting Locations

Investigative Site
Chandler, Arizona 85224

Investigative Site
DeLand, Florida 32720

Investigative Site
Hillsborough, New Jersey 08844

Investigative Site
Seattle, Washington 98105

More Details

NCT ID
NCT06903338
Status
Recruiting
Sponsor
Vir Biotechnology, Inc.

Study Contact

Study Inquiry
415-654-5281
clinicaltrials@vir.bio

For help using this page: trialstoday@researchmatch.org or call 855-514-7001

ResearchMatch is funded in part by the National Institutes of Health (NIH) Clinical and Translational Science Award (CTSA) program, led by the NIH’s National Center for Advancing Translational Sciences (NCATS), grants UL1TR000445 and 1U54RR032646-01, and grant U24TR001579 from NCATS and the National Library of Medicine. The content of this website is solely the responsibility of ResearchMatch and Vanderbilt University and does not necessarily represent the official views of the NIH, NCATS, or NLM.

Vanderbilt University Medical Center