A Study to Evaluate Tobevibart + Elebsiran in Chronic HDV Infection

Phase 3

Recruiting

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

• Registration Number: NCT06903338
• Lead Sponsor: Vir Biotechnology, Inc.

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2025-03-12
• Study First Submitted: 2025-03-24
• Study First Submitted QC: 2025-03-24
• Study First Posted: 2025-03-30
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-16
• Last Update Posted: 2025-05-20
• Primary Completion: 2026-12-31
• Study Completion: 2031-05

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 120

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm 1 (Tobevibart + Elebsiran)	Tobevibart	Participants will receive treatment with tobevibart + elebsiran for 240 weeks.
Arm 2 (Tobevibart + Elebsiran)	Tobevibart	Participants will receive tobevibart + elebsiran after an observational period for 240 weeks.
Arm 1 (Tobevibart + Elebsiran)	Elebsiran	Participants will receive treatment with tobevibart + elebsiran for 240 weeks.
Arm 2 (Tobevibart + Elebsiran)	Elebsiran	Participants will receive tobevibart + elebsiran after an observational period for 240 weeks.

Primary Outcome Measures

Name	Time	Method
HDV RNA < Lower Limit of Quantification (LLOQ), Target Not Detected (TND) and alanine aminotransferase (ALT) normalization (ALT </= Upper Limit of Normal [ULN]) at Week 48 for Arm 1 vs at Week 12 for Arm 2	Up to 48 weeks
Incidence of Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) through Week 12	Up to 12 weeks

Secondary Outcome Measures

Name	Time	Method
HDV RNA < LLOQ, TND at Week 48 for Arm 1 vs Week 12 for Arm 2	Up to 48 weeks

Trial Locations

Locations (1)

Investigative Site; 🇲🇩 Chisinau, Moldova, Republic of