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Active Not Recruiting
NCT06903338
A Study to Evaluate Tobevibart + Elebsiran in Chronic HDV Infection
Conditions: Viral Hepatitis
Sex: All
Ages: 18 Years – 70 Years
Healthy volunteers: No
Phase: PHASE3
Enrollment: 124
Sponsor: Vir Biotechnology, Inc.
Location: Investigative Site Chandler Arizona
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.
Eligibility Criteria
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
Source: ClinicalTrials.gov (NCT06903338). StuddyBuddy aggregates publicly available trial information.