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

A Phase 2b Randomized, Open-Label Study to Evaluate the Efficacy and Safety of Tobevibart+Elebsiran Combination Therapy Versus Bulevirtide in Participants With Chronic HDV Infection (ECLIPSE 3)

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07142811

Enrollment

100

Registered

2025-08-27

Start date

2025-08-05

Completion date

2030-07-01

Last updated

2026-01-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Viral Hepatitis

Keywords

HDV, Hepatitis D Virus, Hepatitis, Chronic Hepatitis D Virus, Hepatitis D, Hepatitis D, Chronic, Hepatitis Delta Virus, Digestive System Diseases, Liver Diseases

Brief summary

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

Interventions

DRUGTobevibart

Tobevibart administered by subcutaneous injection

DRUGElebsiran

Elebsiran administered by subcutaneous injection

DRUGBulevirtide

Bulevirtide administered by subcutaneous injection

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

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

Design outcomes

Primary

Measure	Time frame
HDV RNA < Lower Limit of Quantification (LLOQ), Target not detected (TND) at Week 48	Week 48
HDV RNA < Lower Limit of Quantification (LLOQ), Target not detected (TND) 24 weeks after end of treatment	24 Weeks after End of Treatment
Incidence of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) through Week 48	Week 48

Secondary

Measure	Time frame
Change from baseline in HDV RNA at Week 48	Week 48
Change from baseline in ALT at Week 48	Week 48
HDV RNA < Lower Limit of Quantification (LLOQ), Target not detected (TND) at Week 96, Week 120, Week 144, Week 192 and Week 240	Week 96, Week 120, Week 144, Week 192 and Week 240
Change from baseline in HDV RNA at Week 96, Week 120, Week 144, Week 192 and Week 240	Week 96, Week 120, Week 144, Week 192 and Week 240
Change from baseline in ALT at Week 96, Week 120, Week 144, Week 192 and Week 240	Week 96 to Week 120, Week 144, Week 192 and Week 240

Countries

Belgium, Bulgaria, France, Germany, Moldova, Netherlands, Pakistan, Romania, Spain, Ukraine, United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026