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

Not Applicable

Recruiting

• Conditions: Viral Hepatitis
• Interventions: Drug: Tobevibart; Drug: Elebsiran; Drug: Bulevirtide

• Registration Number: NCT07128550
• Lead Sponsor: Vir Biotechnology, Inc.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2025-07-30
• Status Verified: 2025-08
• Study First Submitted: 2025-08-13
• Study First Submitted QC: 2025-08-13
• Last Update Submitted: 2025-08-13
• Study First Posted: 2025-08-19
• Last Update Posted: 2025-08-19
• Primary Completion: 2026-12
• Study Completion: 2031-07-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 150

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 < 20 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm 1	Tobevibart	Participants will receive treatment with tobevibart + elebsiran up to 240 weeks.
Arm 1	Elebsiran	Participants will receive treatment with tobevibart + elebsiran up to 240 weeks.
Arm 2	Tobevibart	Participants will receive Bulevirtide for 24 weeks and switch to receive tobevibart + elebsiran for additional 216 weeks
Arm 2	Elebsiran	Participants will receive Bulevirtide for 24 weeks and switch to receive tobevibart + elebsiran for additional 216 weeks
Arm 2	Bulevirtide	Participants will receive Bulevirtide for 24 weeks and switch to receive tobevibart + elebsiran for additional 216 weeks

Primary Outcome Measures

Name	Time	Method
HDV RNA < Lower Limit of Quantification (LLOQ), Target not detected (TND) at Week 24	Week 24
HDV RNA < Lower Limit of Quantification (LLOQ), Target not detected (TND) 24 weeks after end of treatment.	24 Weeks after End of Treatment

Secondary Outcome Measures

Name	Time	Method
Incidence of Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) through Week 24, Week 48, Week 96	Week 24, Week 48 and Week 96
HDV RNA < Lower Limit of Quantification (LLOQ), Target not detected (TND) at Week 48, Week 96, Week 144, Week 192 and Week 240	Week 48 , Week 96, Week 144, Week 192 and Week 240
Change from baseline in ALT at Week 24, Week 48 and Week 96	Week 24, Week 48 and Week 96

Trial Locations

Locations (1)

Investigative Site; 🇬🇧 Nottingham, United Kingdom