A Study to Evaluate Tobevibart+Elebsiran Versus Bulevirtide in Chronic HDV Infection

Vir Biotechnology

Status and phase: Active, not recruiting; Phase 2

Conditions: Viral Hepatitis

Treatments: Drug: Elebsiran; Drug: Tobevibart; Drug: Bulevirtide

Study type: Interventional

Funder types: Industry

Identifiers

NCT07142811

VIR-CHDV-V206

Details and patient eligibility

About

A Study to Evaluate Tobevibart+Elebsiran versus Bulevirtide in Chronic HDV Infection

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Male or female ages 18 to 70 years at screening
2. Positive HDV antibody or positive HDV RNA PCR result for at least 6 months prior to screening and HDV RNA ≥ 500 IU/mL at screening
3. Noncirrhotic or compensated cirrhotic liver disease at screening
4. On NRTI therapy against HBV for at least 12 weeks prior to day 1 or have HBV DNA < 10 IU/ml at screening, currently on locally approved NRTI therapy

Exclusion criteria

1. Serum ALT ≥ 5 × ULN
2. Any clinically significant chronic or acute medical or psychiatric condition that makes the participant unsuitable for participation.
3. History of significant liver disease from non-HBV or non-HDV etiology
4. History of allergic reactions, hypersensitivity, or intolerance to study drug, its metabolites, or excipients.
5. History of anaphylaxis
6. History of immune complex disease
7. History of autoimmune disorder
8. Current therapy or therapy within 24 weeks of screening with an immunomodulatory agent, immune checkpoint inhibitors, immunosuppressants, cytotoxic or chemotherapeutic agent, or chronic systemic corticosteroids.
9. Any previous treatment with Bulivertide

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

Arm 1

Experimental group

Description:

Participants will receive treatment with tobevibart + elebsiran up to 240 weeks.

Treatment:

Drug: Tobevibart

Drug: Elebsiran

Arm 2

Experimental group

Description:

Participants will receive Bulevirtide for approximately 48 weeks and switch to receive tobevibart + elebsiran for additional 192 weeks

Treatment:

Drug: Bulevirtide

Drug: Tobevibart

Drug: Elebsiran