A Study to Evaluate Tobevibart + Elebsiran in Chronic HDV Infection

A Phase 3 Randomized, Open-Label Study to Evaluate the Efficacy and Safety of Tobevibart + Elebsiran Combination Therapy in Participants With Chronic HDV Infection (ECLIPSE 1)

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06903338

Enrollment

124

Registered

2025-03-30

Start date

2025-03-12

Completion date

2031-05-01

Last updated

2026-04-08

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

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.

Interventions

DRUGTobevibart

Tobevibart administered by subcutaneous injection

DRUGElebsiran

Elebsiran 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. 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

Design outcomes

Primary

Measure	Time frame
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

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

Countries

Canada, Georgia, Germany, Moldova, New Zealand, Pakistan, Romania, Ukraine, United Kingdom, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 9, 2026