A Study to Evaluate Tobevibart+Elebsiran in Participants With Chronic HDV Infection Not Virologically Suppressed With Bulevirtide

Vir Biotechnology

Status and phase: Enrolling; Phase 3

Conditions: Viral Hepatitis

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT07128550

VIR-CHDV-V205

Details and patient eligibility

About

This is a multicenter, open label, randomized Phase 3 clinical study to evaluate tobevibart + elebsiran in participants with Chronic HDV Infection not virologically suppressed with bulevirtide

Enrollment: 150 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. HDV RNA ≥ 500 IU/mL at screening
3. Receiving BLV 2 mg SC QD for ≥ 24 weeks at Day 1
4. Noncirrhotic or compensated cirrhotic liver disease at screening
5. 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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150 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 24 weeks and switch to receive tobevibart + elebsiran for additional 216 weeks

Treatment:

Drug: Tobevibart

Drug: Elebsiran

Drug: Bulevirtide