Trials Today

A Study to Evaluate Tobevibart + Elebsiran in Chronic HDV Infection

Purpose

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.

Condition

Viral Hepatitis

Eligibility

Eligible Ages: Between 18 Years and 70 Years
Eligible Genders: All
Accepts Healthy Volunteers: No

Inclusion Criteria

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

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

Study Design

Phase: Phase 3
Study Type: Interventional
Allocation: Randomized
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
Masking: None (Open Label)

Arm Groups

Arm	Description	Assigned Intervention
Experimental Arm 1 (Tobevibart + Elebsiran)	Participants will receive treatment with tobevibart + elebsiran for 240 weeks.	Drug: Tobevibart Tobevibart administered by subcutaneous injection Other names: VIR-3434 Drug: Elebsiran Elebsiran administered by subcutaneous injection Other names: VIR-2218
Experimental Arm 2 (Tobevibart + Elebsiran)	Participants will receive tobevibart + elebsiran after an observational period for 240 weeks.	Drug: Tobevibart Tobevibart administered by subcutaneous injection Other names: VIR-3434 Drug: Elebsiran Elebsiran administered by subcutaneous injection Other names: VIR-2218

Recruiting Locations

Investigative Site
Chandler, Arizona 85224

Investigative Site
DeLand, Florida 32720

Investigative Site
Hillsborough, New Jersey 08844

Investigative Site
Seattle, Washington 98105

More Details

NCT ID: NCT06903338
Status: Recruiting
Sponsor: Vir Biotechnology, Inc.

Study Contact

Study Inquiry
415-654-5281
clinicaltrials@vir.bio

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.