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Clinical Trials in France / NCT05461170
Active, not recruiting Phase 2

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

NCT05461170 · tracked via the Priya Life Science France tracker
Sponsor
Vir Biotechnology, Inc
Phase
Phase 2
Started
2022-09-17
Last updated
2026-06-26

Condition(s) studied

Hepatitis D, Chronic

Investigational drug(s) / intervention(s)

VIR-2218 →VIR-3434 →NRTI

VIR-2218: VIR-2218 given by subcutaneous injection

VIR-3434: VIR-3434 given by subcutaneous injection

NRTI: NRTI given orally.

Study summary

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

Eligibility

Sex
ALL
Min age
18 Years
Max age
69 Years
Healthy volunteers
No
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

Primary outcome measure(s)

  • 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 — Up to 24 Weeks
  • Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) — Up to 360 Weeks

Trial sites (20)

FacilityCityRegionStatus
Investigative Site Sofia Bulgaria
Investigative Site Sofia Bulgaria
Investigative Site Stara Zagora Bulgaria
Investigative Site Clichy France
Investigative Site Pessac France
Investigative Site Rennes France
Investigative Site Toulouse France
Investigative Site Frankfurt Germany
Investigative Site Hanover Germany
Investigative Site Tübingen Germany
Investigative Site Milan Italy
Investigative Site Pisa Italy
Investigative Site Chisinau Moldova
Investigative Site Rotterdam Netherlands
Investigative Site Auckland New Zealand
Investigative Site Bucharest Romania
Investigative Site Birmingham United Kingdom
Investigative Site London United Kingdom
Investigative Site London United Kingdom
Investigative Site Manchester United Kingdom

More Vir Biotechnology, Inc. trials in France

A Study to Evaluate Tobevibart+Elebsiran Versus Bulevirtide in Chronic HDV Infection Active, not recruiting
To Access the Safety and Effects of Intravenous Administration of VIR-5818 Alone and in Combination With Pembrolizumab in Adult Participants With Locally Advanced or Metastatic HER2-Expressing Cancers Recruiting
A Study to Evaluate Tobevibart+Elebsiran in Participants With Chronic HDV Infection Not Virologically Suppressed With Bulevirtide Active, not recruiting

Other trials for the same condition

National Cohort of Patients Co-infected With Hepatitis B and Delta Viruses Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05461170 on ClinicalTrials.gov ↗ ← All trials in France