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NCT Number: NCT05461170

SOLSTICE: Combination Therapy for the Treatment of Chronic Hepatitis D Infection.

This is a phase 2 trial in which participants with chronic hepatitis D virus (HDV) infection will receive VIR-2218 and/or VIR-3434 and be assessed for safety, tolerability, and efficacy

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

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

Age range

18 year–69 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Investigative Site, Sofia, Bulgaria

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About this study

Participants may be enrolled into Cohort 1 (1a and 1b) or Cohort 2 (2a, 2b1 or 2b2, 2c), 3, 4, and 5. All participants still receiving VIR-2218 or VIR-3434 monotherapy at the time of implementation of Protocol Amendment 4 will switch to combination therapy at Week 132 (Cohort 2a, 2b1/2b2) or Week 112 (Cohort 3).

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 for at least 12 weeks prior to day 1
  • ALT>ULN and < 5x ULN
  • Non-cirrhotic and CPT-A cirrhotic

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
  • Prior or concomitant therapy with an immunomodulatory agent, IFN-alpha, cytotoxic or chemotherapeutic agent, or chronic corticosteroids.
  • Anti-HBs >10 mIU/mL at screening

Treatment and study plan

VIR-2218

Drug

VIR-2218 given by subcutaneous injection

Other names: Elebsiran

VIR-3434

Drug

VIR-3434 given by subcutaneous injection

Other names: Tobevibart

NRTI

Drug

NRTI given orally.

Primary outcomes

  1. Proportion of participants with undetectable HDV RNA (< limit of detection [LOD]) or ≥ 2 log10 decrease in HDV RNA from baseline and alanine aminotransferase (ALT) normalization (ALT < upper limit of normal [ULN]) at Week 24

    Time frame: Up to 24 Weeks

  2. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs)

    Time frame: Up to 360 Weeks

Secondary outcomes

  1. Proportion of participants with undetectable HDV RNA (less than LOD) or greater than/equal to 2 log10 decrease in HDV RNA from baseline and ALT normalization at Week 12, Week 48, Week 72, Week 96, Week 144, Week 192, Week 240, Week 288, and Week 336.

    Time frame: Up to 336 Weeks

  2. Proportion of participants with undetectable HDV RNA (less than LOD) or greater than/equal to 2 log10 decrease in HDV RNA from baseline at Week 12, Week 24, Week 48, Week 72, Week 96, Week 144, Week 192, Week 240, Week 288, and Week 336.

    Time frame: Up to 336 Weeks

  3. Proportion of participants with undetectable HDV RNA (less than LOD) at Week 12, Week 24, Week 48, Week 72, Week 96, Week 144, Week 192, Week 240, Week 288, and Week 336.

    Time frame: Up to 336 Weeks

  4. Proportion of participants with HDV RNA < lower limit of quantitation (LLOQ) at Week 12, Week 24, Week 48, Week 72, Week 96, Week 144, Week 192, Week 240, Week 288, and Week 336.

    Time frame: Up to 336 Weeks

  5. Change from baseline in HDV RNA at Week 12, Week 24, Week 48, Week 72, Week 96, Week 144, Week 192, Week 240, Week 288, and Week 336.

    Time frame: Up to 336 Weeks

  6. Proportion of participants with ALT normalization at Week 12, Week 24, Week 48, Week 72, Week 96, Week 144, Week 192, Week 240, Week 288, and Week 336.

    Time frame: Up to 336 Weeks

  7. Incidence of anti-drug antibodies (ADA) and titers of ADA to VIR-3434 at specified study visits up to Week 336 (for cohorts with VIR3434)

    Time frame: Up to 336 Weeks

  8. Change from baseline in liver fibrosis at Week 48, Week 96, Week 144, Week 192, Week 240, Week 288, and Week 336.

    Time frame: Up to 336 Weeks.

    Liver Fibrosis will be measured by conventional Transient Elastography imaging technique reported in kPa.

  9. Change from baseline in Model for End Stage Liver Disease (MELD) score at Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96, Week 144, Week 192, Week 240, Week 288, and Week 336.

    Time frame: Up to 336 Weeks

    MELD score will be calculated using serum bilirubin, serum creatinine, and International Normalized Ratio.

  10. Change from baseline in Child-Pugh-Turcotte (CPT) score at Week 24, Week 48, Week 72, Week 96, Week 144, Week 192, Week 240, Week 288, and Week 336.

    Time frame: Up to 336 Weeks

Sponsors and collaborators

Lead sponsor

Vir Biotechnology, Inc.

Industry

Registry information

Official study title

A Phase 2 Study to Evaluate Efficacy, Safety and Tolerability of VIR-2218 and VIR-3434 in Participants With Chronic Hepatitis D Virus Infection (SOLSTICE)

Important dates

Study start
2022
Primary completion
2031
Study completion
2032
First posted
Jul 18, 2022
Registry last updated
Jun 26, 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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