Summary

Eligibility
for people ages 18-70 (full criteria)
Location
at San Francisco, California and other locations
Dates
study started
study ends around

Description

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.

Official Title

A Phase 3 Randomized, Open-Label Study to Evaluate the Efficacy and Safety of Tobevibart + Elebsiran Combination Therapy in Participants With Chronic HDV Infection (ECLIPSE 1)

Keywords

Viral Hepatitis, HDV, Hepatitis D Virus, Hepatitis, Chronic Hepatitis D Virus, Hepatitis D, Hepatitis D, Chronic, Hepatitis Delta Virus, Tobevibart, Elebsiran, Tobevibart + Elebsiran

Eligibility

You can join if…

Open to people ages 18-70

  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

You CAN'T join if...

  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

  • Investigative Site accepting new patients
    San Francisco California 94143 United States
  • Investigative Site accepting new patients
    Redwood City California 94063 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Vir Biotechnology, Inc.
ID
NCT06903338
Phase
Phase 3 research study
Study Type
Interventional
Participants
Expecting 120 study participants
Last Updated