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NCT Number: NCT07128550

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

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

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This study is active but is not currently recruiting participants.

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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, Innsbruck, Austria

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
  • HDV RNA ≥ 500 IU/mL at screening
  • Receiving BLV 2 mg SC QD for ≥ 24 weeks at Day 1
  • Noncirrhotic or compensated cirrhotic liver disease at screening
  • 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

  • Serum ALT ≥ 5 × ULN
  • 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
  • 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.

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

Bulevirtide

Drug

Bulevirtide administered by subcutaneous injection

Other names: Hepcludex

Primary outcomes

  1. HDV RNA < Lower Limit of Quantification (LLOQ), Target not detected (TND) at Week 24

    Time frame: Week 24

  2. HDV RNA < Lower Limit of Quantification (LLOQ), Target not detected (TND) 24 weeks after end of treatment.

    Time frame: 24 Weeks after End of Treatment

Secondary outcomes

  1. Incidence of Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) through Week 24, Week 48, Week 96, Week 120, Week 144, Week 192, and Week 240

    Time frame: Week 24, Week 48, Week 96, Week 120, Week 144, Week 192, and Week 240

  2. HDV RNA < Lower Limit of Quantification (LLOQ), Target not detected (TND) at Week 48, Week 96, Week 120, Week 144, Week 192 and Week 240

    Time frame: Week 48 , Week 96, Week 120, Week 144, Week 192 and Week 240

  3. Change from baseline in ALT at Week 24, Week 48, Week 96, Week 120, Week 144, Week 192, and Week 240

    Time frame: Week 24, Week 48, Week 96, Week 120, Week 144, Week 192, and Week 240

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 Not Virologically Suppressed With Bulevirtide (ECLIPSE 2)

Important dates

Study start
2025
Primary completion
2026
Study completion
2031
First posted
Aug 19, 2025
Registry last updated
Jul 13, 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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