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

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-70
SponsorVir Biotechnology, Inc.

About this trial

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 criteria

Qualifiers

Male or female ages 18 to 70 years at screening

HDV RNA ≥ 500 IU/mL at screening

Receiving BLV 2 mg SC QD for ≥ 24 weeks at Day 1

Noncirrhotic or compensated cirrhotic liver disease at screening

Disqualifiers

Serum ALT ≥ 5 × ULN

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 etiology

History of allergic reactions, hypersensitivity, or intolerance to study drug, its metabolites, or excipients.

Trial design

Treatments tested in this trial

  • Tobevibart
  • Elebsiran
  • Bulevirtide

Treatment groups

150 Participants
are divided into 2 treatment groups

Sponsors and collaborators