ACTIVE_NOT_RECRUITING

A Study to Evaluate Tobevibart + Elebsiran in Chronic HDV Infection

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Conditions

Viral HepatitisHDVHepatitis D VirusHepatitisChronic Hepatitis D VirusHepatitis DHepatitis D, ChronicHepatitis Delta Virus

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

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)

Quick Facts

Study Start:2025-03-12
Study Completion:2031-05
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT06903338

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.

Ages Eligible for Study:18 Years to 70 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Male or female ages 18 to 70 years at screening
  2. 2. Chronic HDV infection for \>/= 6 months
  3. 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. 4. Serum ALT \> ULN and \< 5x ULN
  5. 5. Non-cirrhotic or Compensated Cirrhotic Liver Disease at screening
  1. 1. Any clinically significant chronic or acute medical or psychiatric condition that makes the participant unsuitable for participation.
  2. 2. History of significant liver disease from non-HBV or non-HDV etiology
  3. 3. History of allergic reactions, hypersensitivity, or intolerance to study drug, its metabolites, or excipients.
  4. 4. History of anaphylaxis
  5. 5. History of immune complex disease
  6. 6. History of autoimmune disorder
  7. 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

Contacts and Locations

Study Locations (Sites)

Investigative Site
Chandler, Arizona, 85224
United States
Investigative Site
Los Angeles, California, 90033
United States
Investigative Site
Redwood City, California, 94063
United States
Investigative Site
San Francisco, California, 94143
United States
Investigative Site
DeLand, Florida, 32720
United States
Investigative Site
Chicago, Illinois, 60612
United States
Investigative Site
Baltimore, Maryland, 21287
United States
Investigative Site
Hillsborough, New Jersey, 08844
United States
Investigative Site
New York, New York, 10016
United States
Investigative Site
New York, New York, 10021
United States
Investigative Site
New York, New York, 10029
United States
Investigative Site
Murray, Utah, 84107
United States
Investigative Site
Seattle, Washington, 98105
United States

Collaborators and Investigators

Sponsor: Vir Biotechnology, Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-03-12
Study Completion Date2031-05

Study Record Updates

Study Start Date2025-03-12
Study Completion Date2031-05

Terms related to this study

Keywords Provided by Researchers

  • HDV
  • Hepatitis D Virus
  • Hepatitis
  • Chronic Hepatitis D Virus
  • Hepatitis D
  • Hepatitis D, Chronic
  • Hepatitis Delta Virus

Additional Relevant MeSH Terms

  • Viral Hepatitis