A Study to Evaluate Tobevibart + Elebsiran in Chronic HDV Infection

Description

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.

Conditions

Viral Hepatitis

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Study Overview

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Study Details

Study 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.

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)

A Study to Evaluate Tobevibart + Elebsiran in Chronic HDV Infection

Condition
Viral Hepatitis
Intervention / Treatment

-

Contacts and Locations

Chandler

Investigative Site, Chandler, Arizona, United States, 85224

DeLand

Investigative Site, DeLand, Florida, United States, 32720

Hillsborough

Investigative Site, Hillsborough, New Jersey, United States, 08844

Seattle

Investigative Site, Seattle, Washington, United States, 98105

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • 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

Ages Eligible for Study

18 Years to 70 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Vir Biotechnology, Inc.,

Study Record Dates

2031-05