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OpenTrials
Active, Not Recruiting

NCT Number: NCT06903338

A Study to Evaluate Tobevibart + Elebsiran in Chronic HDV Infection

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Viral Hepatitis Chronic Disease Digestive System Diseases Disease Attributes Hepatitis Hepatitis D Hepatitis D, Chronic Hepatitis, Chronic Hepatitis, Viral, Human Infections Liver Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms RNA Virus Infections Virus Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Investigative Site, Calgary, Alberta, Canada

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Male or female ages 18 to 70 years at screening
  • Chronic HDV infection for >/= 6 months
  • 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
  • Serum ALT > ULN and < 5x ULN
  • Non-cirrhotic or Compensated Cirrhotic Liver Disease at screening

Exclusion criteria

  • Any clinically significant chronic or acute medical or psychiatric condition that makes the participant unsuitable for participation.
  • History of significant liver disease from non-HBV or non-HDV etiology
  • History of allergic reactions, hypersensitivity, or intolerance to study drug, its metabolites, or excipients.
  • History of anaphylaxis
  • History of immune complex disease
  • History of autoimmune disorder
  • 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

Treatment and study plan

Tobevibart

Drug

Tobevibart administered by subcutaneous injection

Other names: VIR-3434

Elebsiran

Drug

Elebsiran administered by subcutaneous injection

Other names: VIR-2218

Primary outcomes

  1. 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

    Time frame: Up to 48 weeks

  2. Incidence of Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) through Week 12

    Time frame: Up to 12 weeks

Secondary outcomes

  1. HDV RNA < LLOQ, TND at Week 48 for Arm 1 vs Week 12 for Arm 2

    Time frame: Up to 48 weeks

Sponsors and collaborators

Lead sponsor

Vir Biotechnology, Inc.

Industry

Registry information

Official study title

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)

Important dates

Study start
2025
Primary completion
2026
Study completion
2031
First posted
Mar 30, 2025
Registry last updated
Apr 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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